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EVIDENCE BASED PRACTICES IN OBSTETRICS AND GYNAECOLOGY

CONTENT
1. Introduction
2. Evidence based practices in Gynaecology
3. Evidence based practices in Pregnancy, labour and Puerperium
4. Evidence based practices in Neonatology

EVIDENCE BASED PRACTICES IN OBSTETRICAL AND GYNAECOLOGICAL NURSING


"Knowing is not enough; we must apply. Willing is not enough, we must do"
(The Cicily statement on evidence-based practice)

INTRODUCTION

Within the nursing profession, it is expected that new information in the form of research
findings will be incorporated constantly and knowledgeably into nursing practice. The staff
nurse is a critical link in bringing research-based changes into clinical practice. Depending
on the environment, a health care organization may or may not have the resources to ensure
critical, succinct, reasonable evaluation and application of research findings as they relate to
the point-of-care delivery. Health care organizations are beginning to create mechanisms to
facilitate the process of information translation from the literature to practice. Evidence
based practice is sometimes indicative of an attempt to avoid the µnature of the evidence
being detained by the bias of a particular professional grouping. The emphasis is on practice
and this determines the nature of evidence that would besought.
The ability to deliver evidence-based practice promotes individualisation of care and
assures the quality of health care for patients today as well as those of tomorrow
Critical thinking is vital to evidence-based nursing practice. Evidence-based practice (EBP)
supports nursing care and can contribute positively to patient outcomes across a variety of
settings and geographic locations. The nature of EBP, its relevance to nursing, and the skills
needed to support it should be required components of baccalaureate education and must be
introduced early in students' development as independent, self-directed learners and
as professional nurses. Among the knowledge, skills, and processes needed to support EBP,
Critical thinking is paramount.
STEPS OF EVIDENCE BASED PRACTICE

Asking the relevant clinical question


 Searching for the best evidence
 Appraising the evidence critically
 Integrating evidence with clinical expertise, patient preferences and values
in making a practice decision or change
 Evaluating the practice decision on change

OBSTACLES TO EVIDENCED BASED PRACTISE

 Organizational (lack of facilitates, equipment, overload)


 Structural (regulation, financial disincentives, insufficient investment in training)
 Peer group and supervisors (local standards of care not in line with desired practice)
Professional-patient interaction
 Individual (knowledge, attitude, skills - decisions largely based on rule of thumb,
beliefs rather than on scientific evidence)
EVIDENCE BASED PRACTICES IN GYNAECOLOGY

1. Skin patch and vaginal ring versus combined oral contraceptivesfor contraception
Laureen M Lopez, David A Grimes, Maria F Gallo, Kenneth F Schulz

Objectives
To compare the contraceptive effectiveness, cycle control, adherence (compliance), and safe
ty of the skin patch or the vaginal ring versus combination oral contraceptives (COs)
Selection criteria
All randomized controlled trials comparing the skin patch or vaginal ring with a COC.
Data collection and analysis
Data were abstracted by two authors and entered into RevMan. For dichotomous variables, t
hePeto odds ratio (OR) with 95% confidence intervals (CI) was calculated. For continuousv
ariables, the mean difference was computed.
Main results
The researchers found 5 trials of the skin patch and 10 of the vaginal ring. Contraceptiveeff
ectiveness was similar for the patch or ring versus the comparison COC. More patch usersdi
scontinued early than COC users: ORs were 1.59 (95% CI 1.26 to 2.00), 1.56 (95% CI 1.18
to2.06), and 2.57 (95% CI 0.99 to 6.64). Patch users also had more discontinuation due to a
dverseevents. Compared to COC users, patch users reported more breast discomfort, dysme
norrhea,nausea, and vomiting. Patch users reported more compliant cycles than the COC us
ers in twotrials: ORs were 2.05 (95% CI 1.83 to 2.29) and 2.76 (95% CI 2.35 to 3.24). The r
ing trialsgenerally showed similar discontinuation for ring and COC users. Ring users repor
ted lessnausea, acne, irritability, and depression than COC users. Ring users had more vagin
itis andleukorrhea but less vaginal dryness. Ring users had similar adherence to COC users i
n two trials but less adherence in one. Cycle control was generally similar for the patch and
COC, and wassimilar or better for the ring versus CoC.
Conclusions
Effectiveness was similar for the methods compared. The patch could lead to morediscontin
uation while the vaginal ring showed little difference. The patch group had better complianc
e than the COC group but more side effects. Ring users generally had fewer adverseevents t
han COC users but more vaginal irritation and discharge. High losses to follow up can
affect the validity of the results.

2. Conservative management of pelvic organ prolapse in women

Suzanne Hagen, Diane Stark, Christopher Maher, Elisabeth J Adams

Objectives
To determine the effects of conservative management (physical interventions and lifestyle
interventions) for women with pelvic organ prolapse in comparison with no treatment or
other treatment options (such as mechanical devices or surgery).
Selection criteria
Randomised and quasi-randomised trials in women with pelvic organ prolapse that included
a physical or lifestyle intervention in at least one arm of the trial.
Data collection and analysis
Two reviewers assessed all trials for inclusion/exclusion and methodological quality. Data
were extracted by the lead reviewer onto a standard form and cross checked by
another.Disagreements were resolved by discussion. Data were processed as described in
the Cochrane Handbook for Systematic Reviews of Interventions.
Main results
Three trials of relevance to this review were identified. The largest of these, of pelvic
floor muscle training in preventing anterior prolapse from worsening, had significant
limitations which affect the generalisability and rigor of the findings. A small feasibility
study (which is to be followed up with a larger trial) randomised 47 women to pelvic floor
muscle training or control and found suggestions of better outcomes (better self-reported
improvement, decreased severity) in the intervention group. The third trial evaluated peri-
operative physiotherapy for women undergoing surgery for prolapse and/or
incontinence. The authors report that urinary symptoms, pelvic floor muscle function and
quality of life were improved more in the treatment group than the control group, but data
were not provided to allow this to be assessed. The trial was small and no prolapse-specific
outcome measures were used. It was not possible to combine data from the three trials.
Conclusions
Despite there now being reports of three eligible trials in this update, the evidence
available is not significant to guide practice. There is some encouragement from a
feasibility study that pelvic floor muscle training, delivered by a physiotherapist to
symptomatic women in an outpatient setting, may reduce severity of prolapse. Further
evidence from larger, better quality randomised control trials is however still necessary.

3. Advance provision of emergency contraception for pregnancyprevention


Chelsea B. Polis, David A Grimes, Kate Schaffer, Kelly Blanchard, Anna Glasier, Cynthia Harper

Objectives
The objectives of the study was to to summarize randomized controlled trials evaluating
advance provision of emergency contraception to explore effects on pregnancy rates,
sexually transmitted infections, and sexual and contraceptive behaviors.

Selection criteria
The researchers included randomized controlled trials comparing advance provision and
standard access (i.e., counseling which may or may not have included information about
emergency contraception, or provision of emergency contraception on request at a clinic
or pharmacy).
Main results
Eleven randomized controlled trials met our criteria for inclusion, representing
7695 patients in the United States, China, India and Sweden. Advance provision did not
decrease pregnancy rates(odds ratio (OR) 0.98, 95% confidence interval (CI) 0.76 to 1.25 in
studies for which we included twelve-month follow-up data; OR 0.48, 95% CI 0.18 to
1.29 in a study with seven-month follow-up data; OR 0.92, 95% CI 0.70 to 1.20 in studies
for which we included six-month follow-up data; OR 0.49, 95% CI 0.09 to 2.74 in a study
with three-month follow-up data),despite reported increased use (single use: OR 2.47, 95%
CI 1.80 to 3.40; multiple use: OR 4.13,95% CI 1.77 to 9.63) and faster use (weighted mean
difference (WMD) -12.98 hours, 95% CI -16.66 to -9.31 hours). Advance provision did not
lead to increased rates of sexually transmitted infections (OR 1.01, 95% CI 0.75 to 1.37),
increased frequency of unprotected intercourse, or changes in contraceptive methods.
Women who received emergency contraception in advance were equally likely to use
condoms as other women.

Conclusions
Advance provision of emergency contraception did not reduce pregnancy rates when
compared to conventional provision. Results from primary analyses suggest that advance
provision doesnot negatively impact sexual and reproductive health behaviors and
outcomes. Women should have easy access to emergency contraception, because it can
decrease the chance of pregnancy. However, the interventions tested thus far have not
reduced overall pregnancy rates in the populations studied.

4. Acupuncture for uterine fibroids

Yan Zhang, Weina Peng, Jane Clarke, Zhishun Liu


Objectives
To assess the benefits and harms of acupuncture in women with uterine fibroids
Selection criteria
All randomised controlled trials (RCTs) comparing acupuncture management with placebo
acupuncture, no management, Chinese medication, Western medication or other
managements of uterine fibroids were considered for inclusion. Acupuncture
management included either traditional acupuncture or contemporary
acupuncture, regardless of the source of stimulation (for example, body, electro, scalp,
elongated, fire, hand, fine needle, moxibustion). Acupuncture management without
needling was excluded.
Data collection and analysis
Two review authors assessed trial risk of bias according to our a priori criteria. No trials
were included in this version of the review, therefore no data was collected.
Main results
No randomized double-blind controlled trials met the inclusion criteria .
Conclusions
The effectiveness of acupuncture for the management of uterine fibroids remains uncertain.
More evidence is required to establish the efficacy and safety of acupuncture for uterine
fibroids. There is a continued need for well designed RCTs with long term follow up.
5. Progesterone for premenstrual syndrome

Olive Ford, Anne Lethaby, Helen Roberts, Ben Willem J Mol


Objectives
The objectives were to determine if progesterone has been found to be an effective
treatment for all or some premenstrual symptoms and if adverse events associated with this
treatment have been reported.

Selection criteria
We included randomised double-blind, placebo-controlled trials of progesterone on women
with PMS diagnosed by at least two prospective cycles, without current psychiatric
disorder.
Data collection and analysis
Two reviewers (BM and OF) extracted data independently and decided which trials to
include. Of wrote to trial investigators for missing data.
Main results
From 17 studies, only two met our inclusion criteria. Together they had 280 participants
aged between 18 and 45 years. One hundred and fifteen yielded analysable results. Both
studies measured symptom severity using subjective scales. Differing in design,
participants, dose of progesterone and how delivered, the studies could not be combined in
meta-analysis. Adverse events which may or may not have been side effects of the
treatment were described as mild. Both trials had defects. They intended to exclude women
whose symptoms continued after their periods. When data from ineligible women were
excluded from analysis in one trial, the other women were found to have benefited more
from progesterone than placebo. The smaller study found no statistically significant
difference between oral progesterone, vaginally absorbed progesterone and placebo, but
reported outcomes incompletely.
Conclusions
The trials did not show that progesterone is an effective treatment for PMS nor that it is
not. Neither trial distinguished a subgroup of women who benefited, nor examined claimed
success with high doses.
6. Oral oestrogen and combined oestrogen/progestogen therapy versus placebo for
hot flushes

Alastair H MacLennan, Jessica L Broadbent, Sue Lester, Vivienne Moore


Objectives
To examine the effect of oral HT compared to placebo on these vasomotor symptoms and
the risk of early onset side-effects.
Selection criteria
Double-blind, randomised, placebo-controlled trials of oral HT for at least three months
duration.
Data collection and analysis
Study quality and outcome data were assessed independently. Random effects models were
considered appropriate due to the variety of trial methodologies. The meta-analyses were
explored for sensitivity to trial quality and therapy duration. Symptom frequency and
severity were assessed separately, together with withdrawals and side-effects. Frequency
data were analysed using the Weighted Mean Difference (WMD) between treatment and
placebo outcomes. For severity data, odds ratios were estimated from the proportional odds
model. From115 references originally identified, 24 trials meeting the selection criteria
were included in there view. Study participants totaled 3,329. Trial duration ranged from
three months to three years.
Main results
There was a significant reduction in the weekly hot flush frequency for HT compared to
placebo(WMD -17.92, 95% CI -22.86 to -12.99). This was equivalent to a 75% reduction in
frequency(95% CI 64.3 to 82.3) for HT relative to placebo. Symptom severity was also
significantly reduced compared to placebo (OR 0.13, 95% CI 0.07 to 0.23). Withdrawal for
lack of efficacy occurred significantly more often on placebo therapy (OR 10.51, 95% CI
5.00 to 22.09).Withdrawal for adverse events, commonly breast tenderness, oedema, joint
pain and psychological symptoms, was not significantly increased (OR 1.25, 95% CI 0.83
to 1.90),although the occurrence of any adverse events was significantly increased for HT
(OR 1.41, 95%CI 1.00 to 1.99). In women who were randomised to placebo treatment, a
57.7% (95% CI 45.1 to67.7) reduction in hot flushes was observed between baseline and
end of study.
Conclusions
Oral HT is highly effective in alleviating hot flushes and night sweats. Therapies purported
to reduce such symptoms must be assessed in blinded trials against a placebo or a validated
therapy because of the large placebo effect seen in well conducted randomised controlled
trials, and also because during menopause symptoms may fluctuate and after menopause
symptoms of ten decline. Withdrawals due to side-effects were only marginally increased in
the HT groups despite the inability to tailor HT in these fixed dose trials. Comparisons of
hormonal doses, product types or regimens require analysis of trials with these specific
"within study"comparisons.

7. Oral versus intra-vaginal imidazole and triazole anti-fungal treatment of


uncomplicated vulvovaginal candidiasis (thrush)

Munira Nurbhai, Jeremy Grimshaw, Margaret Watson, Christine M Bond, Jill A Mollison,
Anne Ludbrook
Objectives
The primary objective of this review was to assess the relative effectiveness of oral versus
intra-vaginal anti-fungals for the treatment of uncomplicated vulvovaginal candidiasis.The
secondary objectives of the review were to assess the cost-effectiveness, safety and
patient preference of oral versus intra-vaginal anti-fungals.
Selection criteria
Randomised controlled trials published in any language.Trials had to compare at least one
oral anti-fungal with one intra-vaginal anti-fungal.Women (aged 16 years or over) with
uncomplicated vulvovaginal candidiasis.The diagnosis of vulvovaginal candidiasis to be
made mycologically (i.e. a positive culture and /or microscopy for yeast).Trials were
excluded if they solely involved subjects who were HIV positive,immunocompromised,
pregnant, breast feeding or diabetic.The primary outcome measure was clinical cure.
Data collection and analysis
Two reviewers screened titles and abstracts of the electronic search results and full text
of potentially relevant papers. Independent duplicate abstraction was performed by two
reviewers. Disagreements regarding trial inclusion or data abstraction were resolved by
discussion between the reviewers. Odds ratios were pooled using the fixed effects models
(except for two analyses when random effects models were used because of potentially
important heterogeneity).
Main results
Two new trials reporting three comparisons were found in the update. Nineteen trials are
included in the review, reporting 22 oral versus intra-vaginal anti-fungal comparisons. No
statistically significant differences were shown between oral and intra-vaginal anti-fungal
treatment for clinical cure at short term (OR 0.94, 95% CI, 0.75 to 1.17) and long term (OR
1.07,95% CI, 0.82 to 1.41) follow-up. No statistically significant differences for
mycological cure were observed between oral and intra-vaginal treatment at short term (OR
1.15, 95% CI, 0.94 to1.42). There was a statistically significant difference for long term
follow-up (OR 1.29, 95% CI,1.05 to 1.60) in favour of oral treatment, however the clinical
significance of this result is uncertain. Two trials each reported one withdrawal from
treatment due to an adverse reaction. Treatment preference data were poorly reported.
Conclusions

No statistically significant differences were observed in clinical cure rates of anti-fungals


administered by the oral and intra-vaginal routes for the treatment of uncomplicated vaginal
candidiasis. No definitive conclusion can be made regarding the relative safety of oral
and intra-vaginal anti-fungals for uncomplicated vaginal candidiasis.The decision to
prescribe or recommend the purchase of an anti-fungal for oral or intra-vaginal
administration should take into consideration: safety, cost and treatment preference.Unless
there is a previous history of adverse reaction to one route of administration
or contraindications, women who are purchasing their own treatment should be given full
information about the characteristics and costs of treatment to make their own decision. If
health services are paying the treatment cost, decision-makers should consider whether the
higher cost of some oral anti-fungals is worth the gain in convenience, if this is the patient's
preference.

8. Cervical cap versus diaphragm for contraception

Maria F Gallo, David A Grimes, Kenneth F Schulz, Laureen M Lopez


Objectives
To compare the contraceptive efficacy, safety, discontinuation, and acceptability of the
cervicalcap with that of the diaphragm.
Selection criteria
All randomized controlled trials in any language comparing a cervical cap with a diaphragm
were eligible for inclusion
Data collection and analysis
Articles identified for inclusion were independently abstracted by two reviewers. Data were
entered into RevMan, and a second reviewer verified the data entered. Outcome measures
include contraceptive efficacy, safety, discontinuation, and acceptability. Outcomes were
calculated as Peto odds ratios (OR) with 95% confidence intervals (CI). Life-table and
Kaplan-Meier cumulative rate ratios for selected measures are presented.
Main results
The curves for the life-table cumulative pregnancy rates for the Prentif cap and the
diaphragm did not differ. However, the Kaplan-Meier six-month cumulative
pregnancy rates for the Fem Cap and the diaphragm were not clinically equivalent. The
Prentif cap had more Class I to Class III cervical cytologic conversions than the diaphragm
(OR 2.31; 95% CI 1.04 to 5.11). The FemCap trial did not find differences in Papanicolaou
smear results between the groups. Fewer Prentif cap users had vaginal ulcerations or
lacerations (OR 0.31; 95% CI 0.14 to 0.71) than diaphragm users. Fewer FemCap users had
blood in the device (OR 2.29; 95% CI 1.27 to 4.14), but more had urinary tract infections
(OR 0.59; 95% CI 0.39 to 0.95). In the FemCap trial, similar proportions of women
reported liking their device. However, FemCap users were less likely to use the device
alone after the trial (OR 0.47; 95% CI 0.31 to 0.71) or recommend it to a friend (OR 0.48;
95% CI 0.29 to 0.81).
Conclusions
The Prentif cap was as effective as its comparison diaphragm in preventing pregnancy, but
the FemCap was not. Both cervical caps appear to be medically safe.

9. Adjuvant platinum-based chemotherapy for early stage cervical cancer

Daniela D Rosa, Lídia RF Medeiros, Maria I Edelweiss, Mary C Bozzetti, Paula R Pohlmann, Airton T
Stein, Heather O Dickinson

Objectives
To evaluate the effectiveness and safety of platinum-based adjuvant chemotherapy after
radical hysterectomy, radiotherapy, or both in the treatment of early stage cervical cancer
(stages IA2,IB1 or IIA).
Selection criteria
Randomised controlled trials (RCTs) comparing adjuvant radiotherapy with adjuvant
radiotherapy and cisplatin-chemotherapy after radical surgery for early stage cervix cancer
were included.
Data collection and analysis
Two review authors extracted data independently to assess whether the studies met the
specified inclusion criteria. Any discrepancies were solved by a third and a forth review
author. Meta-analysis was performed using a random effects model, with death and disease
progression as outcomes.

Main results
Three trials were included. Two trials enrolling 325 participants, of whom 297 (91%) were
assessed and compared radiotherapy and chemotherapy with radiotherapy alone found that
adjuvant chemotherapy significantly reduced the risk of death (hazard ratio (HR) = 0.56,
95%confidence interval (CI): 0.36 to 0.87) and disease progression (HR = 0.47, 95%CI:
0.30 to0.74), with no heterogeneity between trials (I= 0% for both meta-analyses). One trial
assessing71 participants compared chemotherapy followed by radiotherapy with
radiotherapy alone and found no significant difference between the two groups (HR = 1.34;
95%CI: 0.24 to 7.66). The median follow up of patients varied from 29 to 42 months.
Conclusions
The addition of platinum-based chemotherapy to radiotherapy may offer clinical benefit in
the adjuvant treatment of early stage cervical cancer with risk factors for recurrence.
However, the evidence is limited because the selected studies were quantitatively and
qualitatively limited, with small number of patients and limited period of follow-up

10. Long versus short course treatment with Metformin and


Clomiphene Citrate for ovulation induction in women with PCO

Supat Sinawat, Pranom Buppasiri, Pisake Lumbiganon, Porjai Pattanittum

Objectives
To determine the effectiveness of short-course (less than four weeks) metformin plus CC
versus long-course (four weeks or more) metformin plus CC with regard to ovulation and
achievement of pregnancy in infertile PCOS women.
Selection criteria
Randomised controlled trials comparing short-course (less than four weeks) metformin plus
CC versus long-course (four weeks or more) metformin plus CC for ovulation or
achievement of pregnancy in infertile PCOS women.
Data collection and analysis
No trials were found that met the selection criteria.
Main results
No randomised controlled trials were identified.

Conclusions
There are insufficient data to determine whether short-house metformin pretreatment is as
effective as the conventional long-course metformin pretreatment before initiation of
clomiphenecitrate for ovulation induction in infertile PCOS patients. A well-designed
randomised controlled trial is needed to answer this important clinical question.

EVIDENCE BASED PRACTICES IN PREGNANCY, LABOUR AND PUERPERIUM

1. Immersion in water in labour and birth

Elizabeth R Cluett, Ethel Burns


Objectives
To assess the evidence from randomised controlled trials about immersion in water during
labour and waterbirth on maternal, fetal, neonatal and caregiver outcomes.
Selection criteria
Randomised controlled trials comparing any bath tub/pool with no immersion during
labour and/or birth.
Main results
This review includes 11 trials (3146 women); eight related to the first stage of labour, one to
the first and second stages, one to early versus late immersion in the first stage of labour,
and another to the second stage. We identified no trials evaluating different baths/pools, or
the management of third stage of labour.Results for the first stage of labour showed there
was a significant reduction in the epidural/spinal/paracervical analgesia/anaesthesia rate
amongst women allocated to water immersion compared to controls (478/1254 versus
529/1245; odds ratio (OR) 0.82, 95%confidence interval (CI) 0.70 to 0.98, six trials). There
was no difference in assisted vaginal deliveries (OR 0.84, 95% CI 0.66 to 1.06, seven
trials), caesarean sections (OR 1.23, 95% CI0.86 to 1.75, eight trials), perineal trauma
or maternal infection. There were no differences for Apgar score less than seven at five
minutes (OR 1.59, 95% CI 0.63 to 4.01, five trials), neonatal unit admissions (OR 1.06,
95% CI 0.70 to 1.62, three trials), or neonatal infection rates (OR 2.01, 95% CI 0.50 to 8.07,
five trials).A lack of data for some comparisons prevented robust conclusions. Further
research is needed.
Conclusions
Evidence suggests that water immersion during the first stage of labour reduces the use
of epidural/spinal analgesia. There is limited information for other outcomes related
to water use during the first and second stages of labour, due to intervention and outcome
variability. There is no evidence of increased adverse effects to the fetus/neonate or woman
from labouring in water or waterbirth. The fact that use of water immersion in labour and
birth is now a widely available care option for women threatens the feasibility of a large,
multicentre randomised controlledtrial.

2. Amniotomy for shortening spontaneous labour

Rebecca MD Smyth, S Kate Alldred, Carolyn Markham

Objectives
To determine the effectiveness and safety of amniotomy alone for (1) routinely shortening
all labours that start spontaneously, and (2) shortening labours that have started
spontaneously, but have become prolonged.
Selection criteria
Randomised controlled trials comparing amniotomy alone versus intention to preserve the
membranes. We excluded quasi-randomised trials.
Main results
We have included 14 studies in this review, involving 4893 women. There was no
clear statistically significant difference between the amniotomy and control groups in length
of the first stage of labour (weighted mean difference -20.43 minutes, 95% confidence
interval (CI) -95.93 to 55.06), caesarean section (RR 1.26, 95% CI 0.98 to 1.62), maternal
satisfaction with childbirth experience (standardised mean difference 0.27, 95% CI -0.49 to
1.04) or low Apgar score less than seven at five minutes (RR 0.55, 95% CI 0.29 to 1.05).
There was no consistency between papers regarding the timing of amniotomy during labour
in terms of cervical dilatation.
Conclusions
On the basis of the findings of this review, we cannot recommend that amniotomy should
be introduced routinely as part of standard labour management and care. We do recommend
that the evidence presented in this review should be made available to women offered an
amniotomy and may be useful as a foundation for discussion and any resulting decisions
made between women and their caregivers.

3. Midwife-led versus other models of care for childbearing women

Marie Hatem, Jane Sandall, Declan Devane, Hora Soltani, Simon Gates
Objectives
To compare midwife-led models of care with other models of care for childbearing women
and their infants.
Selection criteria
All published and unpublished trials in which pregnant women are randomly allocated to
midwife-led or other models of care during pregnancy, and where care is provided during
the ante and intrapartum period in the midwife-led model.
Main results
We included 11 trials (12,276 women). Women who had midwife-led models of care were
less likely to experience antenatal hospitalisation, risk ratio (RR) 0.90, 95% confidence
interval (CI)0.81 to 0.99), regional analgesia (RR 0.81, 95% CI 0.73 to 0.91), episiotomy
(RR 0.82, 95% CI0.77 to 0.88), and instrumental delivery (RR 0.86, 95% CI 0.78 to 0.96),
and were more likely to experience no intrapartum analgesia/anaesthesia (RR 1.16, 95% CI
1.05 to 1.29), spontaneous vaginal birth (RR 1.04, 95% CI 1.02 to 1.06), feeling in control
during childbirth (RR 1.74, 95%CI 1.32 to 2.30), attendance at birth by a known midwife
(RR 7.84, 95% CI 4.15 to 14.81) and initiate breastfeeding (RR 1.35, 95% CI 1.03 to 1.76),
although there were no statistically significant differences between groups for caesarean
births (RR 0.96, 95% CI 0.87 to 1.06).Women who were randomised to receive midwife-led
care were less likely to experience fetal loss before 24 weeks' gestation (RR 0.79, 95% CI
0.65 to 0.97), although there were no statistically significant differences in fetal
loss/neonatal death of at least 24 weeks (RR 1.01,95% CI 0.67 to 1.53) or in fetal/neonatal
death overall (RR 0.83, 95% CI 0.70 to 1.00). In addition, their babies were more likely to
have a shorter length of hospital stay (mean difference-2.00, 95% CI -2.15 to -1.85).
Conclusions
Most women should be offered midwife-led models of care and women should be
encouraged to ask for this option although caution should be exercised in applying this
advice to women with substantial medical or obstetric complications.

4. Home-like versus conventional institutional settings for birth

Ellen D Hodnett, Soo Downe, Nadine Edwards, Denis Walsh


Objective
Primary: to assess the effects of care in a home-like birth environment compared to care in
a conventional labour ward. Secondary: to determine if the effects of birth settings are
influenced by staffing or organizational models or geographical location of the birth centre.
Search strategy
We searched the Cochrane Pregnancy and Childbirth Group trials register (18 May 2004)
and hand searched eight journals and two published conference proceedings.
Selection criteria
All randomized or quasi-randomized controlled trials that compared the effects of a home-
like institutional birth environment to conventional hospital care.
Main results
Six trials involving 8677 women were included. No trials of freestanding birth centres were
found. Between 29% and 67% of women allocated to home-like settings were transferred to
standard care before or during labour. Allocation to a home-like setting significantly
increased the likelihood of: no intrapartum analgesia/anaesthesia (four trials; n = 6703;
relative risk (RR)1.19, 95% confidence interval (CI) 1.01 to 1.40), spontaneous vaginal
birth (five trials; n = 8529;RR 1.03, 95% CI 1.01 to 1.06), vaginal/perineal tears (four trials;
n = 8415; RR 1.08, 95% CI1.03 to 1.13), preference for the same setting the next time (one
trial; n = 1230; RR 1.81, 95% CI1.65 to 1.98), satisfaction with intrapartum care (one trial;
n = 2844; RR 1.14, 95% CI 1.07 to1.21), and breastfeeding initiation (two trials; n = 1431;
RR 1.05, 95% CI 1.02 to 1.09) and continuation to six to eight weeks (two trials; n = 1431;
RR 1.06, 95% CI 1.02 to 1.10).Allocation to a home-like setting decreased the likelihood of
episiotomy (five trials; n = 8529;RR 0.85, 95% CI 0.74 to 0.99). There was a trend towards
higher perinatal mortality in the home-like setting (five trials; n = 8529; RR 1.83, 95% CI
0.99 to 3.38). No firm conclusions could be drawn regarding the effects of staffing or
organizational models.
Conclusions
When compared to conventional institutional settings, home-like settings for childbirth
areassociated with modest benefits, including reduced medical interventions and increased
maternalsatisfaction. Caregivers and clients should be vigilant for signs of complications.

5.Patterns of routine antenatal care for low-risk pregnancy

José Villar, Guillermo Carroli, Dina Khan-Neelofu, Gilda GP Piaggio, A Metin Gülmezoglu
Objectives
The objective of this review was to assess the effects of antenatal care programmes for
low-risk women.
Selection criteria
Randomised trials comparing programmes of antenatal care with varied frequency and
timing of the visits and different types of care providers.
Data collection and analysis
Trial quality was assessed and data were extracted by two reviewers independently. Study
authors were contacted for additional information and they were provided with the final
version of the review.
Main results
Ten trials involving over 60,000 women were included. Seven trials evaluated the number
of antenatal clinic visits, and three trials evaluated the type of care provider. Most trials
were of acceptable quality. A reduction in the number of antenatal visits was not associated
with an increase in any of the negative maternal and perinatal outcomes reviewed.
However, trials from developed countries suggest that women can be less satisfied with the
reduced number of visits and feel that their expectations with care are not fulfilled.
Antenatal care provided by amid wife/general practitioner was associated with improved
perception of care by women. Clinical effectiveness of midwife/general practitioner
managed care was similar to that of obstetrician/gynaecologist led shared care.
Authors' conclusions
A reduction in the number of antenatal care visits with or without an increased emphasis on
the content of the visits could be implemented without any increase in adverse biological
maternal and perinatal outcomes. Women can be less satisfied with reduced visits. Lower
costs for the mothers and providers could be achieved. While clinical effectiveness seemed
similar, women appeared to be slightly more satisfied with midwife/general practitioner
managed care compared with obstetrician/gynaecologist led shared care.

6. Biophysical profile for fetal assessment in high risk pregnancies


Joan G Lalor, Bukola Fawole, Zarko Alfirevic, Declan Devane

Objectives
To assess the effects of the BPP when compared with conventional monitoring (CTG only
or MBPP) on pregnancy outcome in high-risk pregnancies.
Selection criteria
Randomised and quasi-randomised controlled trials involving a comparison of fetal BPP
with other forms of antepartum fetal assessment in women with high-risk pregnancies.
Data collection and analysis
Two authors independently assessed eligibility, quality and extracted data.
Main results
We included five trials, involving 2974 women. Most trials were not of high quality.
Although the overall incidence of adverse outcomes was low, available evidence from
randomized controlled trials does not support the use of BPP as a test of fetal wellbeing in
high-risk pregnancies. We found no significant differences between the groups in perinatal
deaths (relative risk (RR) 1.33, 95% confidence interval (CI) 0.60 to 2.98) or in Apgar
score less than seven at five minutes (RR 1.27, 95% CI 0.85 to 1.92).Combined data from
the two high-quality trials suggest an increased risk of caesarean section in the BPP group
RR 1.60, 95% CI 1.05 to 2.44, n= 280, interaction test P = 0.03. However, the number of
participating women was relatively small (n = 280). Therefore, additional evidence is
required in order to be definitive regarding the efficacy of this test in high-risk pregnancies.
Furthermore, the impact of the BPP on other interventions, length of hospitalisation, serious
short-term and long-term neonatal morbidity and parental satisfaction requires further
evaluation.
Authors' conclusions
At present, there is insufficient evidence from randomised trials to support the use of BPP
as a test of fetal wellbeing in high-risk pregnancies.

7. Castor oil, bath and/or enema for cervical priming and induction of labour

Anthony J Kelly, Josephine Kavanagh, Jane Thomas

Selection criteria
Clinical trials comparing castor oil, bath or enemas used for third trimester cervical ripening
or labour induction with placebo/no treatment or other methods listed above it on
a predefined list of labour induction methods.
Data collection and analysis
A strategy was developed to deal with the large volume and complexity of trial data relating
to labour induction. This involved a two-stage method of data extraction.
Main results
In the one included study of 100 women, which compared a single dose of castor oil versus
no treatment, no evidence of a difference was found between caesarean section rates
(relative risk (RR) 2.31, 95% confidence interval (CI) 0.77, 6.87). No data were presented
on neonatal or maternal mortality or morbidity. There was no evidence of a difference
between either the rate of meconium stained liquor (RR 0.77, 95% CI 0.25 to 2.36) or
Apgar score less than seven at five minutes (RR 0.92, 95% CI 0.02 to 45.71) between the
two groups. The number of participants was small hence only large differences in outcomes
could have been detected. All women who ingested castor oil felt nauseous (RR 97.08, 95%
CI 6.16 to 1530.41).
Authors' conclusions
The only trial included in this review attempts to address the role of castor oil as
an induction agent. The trial was small and of poor methodological quality. Further research
is needed to attempt to quantify the efficacy of castor oil as an induction agent.

8 Homoeopathy for induction of labour


Caroline A Smith
Objectives
To determine the effects of homoeopathy for third trimester cervical ripening or induction
of labour.
Selection criteria
Randomised controlled trials comparing homeopathy used for third trimester cervical
ripening or labour induction with placebo/no treatment or other methods listed above it on
a predefined list of labour induction methods.
Data collection and analysis
A generic strategy was developed to deal with the large volume and complexity of trial data
relating to labour induction. This involved a two-stage method of data extraction. The initial
data extraction was done centrally.
Main results
Two trials, involving 133 women, were included in the review. The trials were placebo
controlled and double blind, but the quality was not high. Insufficient information was
available on the method of randomisation and the study lacked clinically meaningful
outcomes. This trials demonstrated no differences in any primary or secondary outcome
between the treatment and control group.
Authors' conclusions
There is insufficient evidence to recommend the use of homoeopathy as a method of
induction. It is likely that the demand for complementary medicine will continue and
women will continue to consult a homoeopath during their pregnancy. Although
caulophyllum is a commonly used homoeopathic therapy to induce labour, the treatment
strategy used in the one trial in which it was evaluated may not reflect routine homoeopathy
practice. Rigorous evaluations of individualised homeopathic therapies for induction of
labour are needed.

9. Medical versus surgical methods for first trimester terminationof pregnancy

Lale Say, Dalia Brahmi, Regina Kulier, Aldo Campana, A Metin Gülmezoglu
Objectives
To evaluate medical methods in comparison to surgical methods for first-trimester abortion
with respect to efficacy, side effects and acceptability.
Selection criteria
Randomised trials of any surgical abortion method compared with any medical abortion
method in the first trimester.
Data collection and analysis
Trial quality was assessed and data extraction was made independently by two reviewers.
Main results
Seven studies mostly with small sample sizes, comparing 4 different
interventions(prostaglandins alone, mifepristone alone, and mifepristone/misoprostol and
methotrexate/misoprostol versus vacuum aspiration) were included. Results are sometimes
based on one trial only. Prostaglandins vs vacuum aspiration: the rate of abortions not
completed with the intended method was statistically significant higher in the prostaglandin
group (2.7, 95% CI 1.1 to 6.8)compared to surgery. There are no data on the most
commonly medical(mifepristone/misoprostol) and surgical abortion available to be included
in the review. Duration of bleeding was longer in the medical abortion groups compared to
vacuum aspiration. There was only one major complication (uterine perforation) in one trial
in the surgical group. There was no difference between the groups for ongoing pregnancies
at the time of follow-up or pelvic infections. No data on acceptability, side effects or
women's satisfaction with the procedure were availbale for inclusion in the review.
Authors' conclusions
The results are derived from relatively small trials. Prostaglandins used alone seems to be
less effective and more painful compared to surgical first-trimester abortion. However, there
is inadequate evidence to comment on the acceptability and side effects of medical
compared to surgical first-trimester abortions. There is a need for trials to address the
efficacy of currently used methods and women's preferences more reliably.

10.Progestogen for treating threatened miscarriage

Hayfaa A Wahabi, Nuha F Abed Althagafi ,Mamoun Elawad, Rasmieh A Al Zeidan

Objectives
To determine the efficacy and the safety of progestogens in the treatment of
threatenedmiscarriage.
Search strategy
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (December
2009) and bibliographies of all located articles for any unidentified articles.
Data collection and analysis
At least two authors assessed the trials for inclusion in the review and extracted the data.
Main results
Two studies (84 participants) were included in the meta-analysis. In one study, all
the participants met the inclusion criteria and in the other study, only the subgroup of
participants who met the inclusion criteria was included in the meta-analysis. There was no
evidence of effectiveness with the use vaginal progesterone compared to placebo in
reducing the risk of miscarriage (risk ratio 0.47; 95% confidence interval 0.17 to 1.30).

Authors' conclusions
Based on scarce data from two methodologically poor trials, there is no evidence to support
the routine use of progestogens for the treatment of threatened miscarriage. Information
about potential harms to the mother or child, or both, with the use of progestogens is
lacking. Further, larger, randomized controlled trials on the effect of progestogens on the
treatment of threatened miscarriage, which investigate potential harms as well as benefits,
are needed.

11.Continuous support for women during childbirth

Ellen D Hodnett, Simon Gates, G Justus Hofmeyr, Carol Sakala

Objectives
Primary: to assess the effects, on mothers and their babies, of continuous, one-to-one
intrapartum support compared with usual care. Secondary: to determine whether the effects
of continuous support are influenced by: (1) routine practices and policies in the birth
environment that may affect a woman's autonomy, freedom of movement and ability to
cope with labour; (2) whether the caregiver is a member of the staff of the institution; and
(3) whether the continuous support begins early or later in labour.
Selection criteria
All published and unpublished randomized controlled trials comparing continuous support
during labour with usual care.
Data collection and analysis
We used standard methods of the Cochrane Collaboration Pregnancy and Childbirth Group.
All authors participated in evaluation of methodological quality. One author and a research
assistant independently extracted the data. We sought additional information from the trial
authors. We used relative risk for categorical data and weighted mean difference for
continuous data to present the results.
Main results
Sixteen trials involving 13,391 women met inclusion criteria and provided usable outcome
data. Primary comparison: women who had continuous intrapartum support were likely to
have as lightly shorter labour, were more likely to have a spontaneous vaginal birth and
less likely to have intrapartum analgesia or to report dissatisfaction with their childbirth
experiences. Subgroup analyses: in general, continuous intrapartum support was associated
with greater benefits when the provider was not a member of the hospital staff, when it
began early in labour and in settings in which epidural analgesia was not routinely
available.
Authors' conclusions
All women should have support throughout labour and birth.

12.Topical treatment for vaginal candidiasis (thrush) in pregnancy

Gavin Young, David Jewell


Objectives
The objective of this review was to assess the effects of different methods of treating
vaginal candidiasis in pregnancy.
Selection criteria
Randomised trials of any treatment for vaginal candidiasis in pregnancy.
Data collection and analysis
Two reviewers assessed trial quality and extracted data.
Main results
Ten trials were included. Based on five trials, imidazole drugs were more effective than
nystatin when treating vaginal candidiasis in pregnancy (odds ratio 0.21, 95% confidence
interval 0.16 to0.29). In turn, Nystatin was as effective as hydrargaphen in one trial (odds
ratio 0.29, 95%confidence interval 0.05-1.84). A trial of clotrimazole was more effective
than placebo (odds ratio 0.14, 95% confidence interval 0.06 to 0.31). Single dose treatment
was no more or less effective than three or four days treatment. However, two trials
involving 81 women, showed that treatment lasting for four days was less effective than
treatment for seven days (odds ratio11.7, 95% confidence interval 4.21 to 29.15). Based on
two trials, treatment for seven days was no more or less effective than treatment for 14 days
(odds ratio 0.41, 95% confidence interval0.16 to 1.05). Terconazole was as effective as
clotrimazole (odds ratio 1.41, 95% confidence interval 0.28- 7.10).
Authors' conclusions
Topical imidazole appears to be more effective than nystatin for treating symptomatic
vaginal candidiasis in pregnancy. Treatments for seven days may be necessary in pregnancy
rather than the shorter courses more commonly used in non-pregnant women.

13. Symphysis-fundal height measurement in pregnancy

James P Neilso

Objectives
The objective of this review was to assess the effects of routine use of symphysis-fundal
height measurements (tape measurement of the distance from the pubic symphysis to the
uterine fundus) during antenatal care on pregnancy outcome.
Selection criteria
Acceptably controlled trials comparing symphysis-fundal height measurement with
assessment by abdominal palpation alone.
Data collection and analysis
One reviewer assessed trial quality and extracted data.
Main results
One trial involving 1639 women was included. No obvious differences were detected in any
of the outcomes measured.
Authors' conclusions
There is not enough evidence to evaluate the use of symphysis-fundal height measurements
during antenatal care

14 .Interventions for suspected placenta praevia


James P Neilson
Objectives

To assess the impact of any clinical intervention applied specifically because of


a perceivedlikelihood that a pregnant woman might have placenta praevia.
Selection criteria
Any controlled clinical trial that has assessed the impact of an intervention in women
diagnosed as having, or being likely to have, placenta praevia.
Data collection and analysis
Data were extracted, unblinded, by the author without consideration of results.
Main results
Three trials were included, involving a total of 114 women. Both tested interventions
(homeversus hospitalisation and cervical cerclage versus no cerclage) were associated with
reduced lengths of stay in hospital antenatally: weighted mean difference (WMD)
respectively -18.50days (95% confidence interval (CI) -26.83 to -10.17), -4.80 days
(95% CI -6.37 to -3.23).Otherwise, there was little evidence of any clear advantage or
disadvantage to a policy of home versus hospital care. The one woman who had a
haemorrhage severe enough to require immediate transfusion and delivery was in the home
care group. Cervical cerclage may reduce the risk of delivery before 34 weeks: relative risk
(RR) 0.45 (95% CI 0.23 to 0.87), or the birth of a baby weighing less than two kilograms
RR 0.34 (0.14 to 0.83) or having a low five minute Apgar score RR 0.19 (0.04 to 1.00). In
general, these possible benefits were more evident in the trial of lower methodological
quality.
Authors' conclusions
There are insufficient data from trials to recommend any change in clinical practice.
Available data should, however, encourage further work to address the safety of more
conservative policies of hospitalisation for women with suspected placenta praevia, and the
possible value of insertion of a cervical suture.

15.Treatments for suppression of lactation

Olufemi T Oladapo, Bukola Fawole


Objectives
To evaluate the effectiveness and safety of interventions used for suppression of lactation
in postpartum women (who have not breastfed or expressed breastmilk) to determine which
approach has the greatest comparative benefits with least risk

Data collection and analysis


Two authors independently assessed trial quality and extracted data.
Main results
We included 46 trials (5164 women). The trials were generally small and of limited quality.
Five trials (206 women) indicated that bromocriptine significantly reduced the proportion of
women lactating compared to no treatment at or within seven days postpartum (three trials,
107 women; relative risk (RR) 0.36, 95% confidence interval (CI) 0.24 to 0.54). Six trials
involving oestrogen preparations (diethylstilbestrol, quinestrol, chlorotrianisene, hexestrol)
suggested that they significantly reduced the proportion of lactating women compared to no
treatment at or within seven days postpartum (RR 0.41, 95% CI 0.29 to 0.59). We found no
trials comparing nonpharmacologic methods with no treatment. Trials comparing
bromocriptine with other pharmacologic agents suggested similarity in their effectiveness
(RR 0.79, 95% CI 0.54 to 1.17).Side effects were poorly reported in the trials and no case of
thromboembolism was recorded in the four trials that reported it as an outcome.
Authors' conclusions
There is weak evidence that some pharmacologic treatments (most of which are currently
unavailable to the public) are better than no treatment for suppressing lactation symptoms in
the first postpartum week. No evidence currently exists to indicate whether non
pharmacologic approaches are more effective than no treatment. Presently, there is
insufficient evidence to address the side effects of methods employed for suppressing
lactation. When women desire treatment, bromocriptine may be considered where it is
registered for lactation suppression in those without predisposition to its major side effects
of public concerns. Large randomized trials are needed to compare the effectiveness of
pharmacologic (especially bromocriptine) and nonpharmacologic methods to no treatment.
Such trials should consider acceptability of the intervention and lactation symptoms of
concern to women and be large enough to detect clinically important differences in major
side effects between comparison groups.

16. Music during caesarean section under regional anaesthesia forimproving maternal
and infant outcomes
Malinee Laopaiboon, Pisake Lumbiganon, Ruth Martis, Patravoot Vatanasapt, BusabaSomjaivong
Objectives
To evaluate the effectiveness of music during caesarean section under regional
anaesthesia for improving clinical and psychological outcomes for mothers and infants.
Selection criteria
We included randomised controlled trials comparing music added to standard care during
caesarean section under regional anaesthesia to standard care alone.
Data collection and analysis
Two review authors, Malinee Laopaiboon and Ruth Martis, independently assessed
eligibility,risk of bias in included trials and extracted data. We analysed continuous
outcomes using a mean difference (MD) with a 95% confidence interval (CI).
Main results
One trial involving 76 women who planned to have their babies delivered by caesarean
section met the inclusion criteria, but data were available for only 64 women. This trial was
of low quality with unclear allocation concealment and only a few main clinical outcomes
reported for the women. The trial did not report any infant outcomes. It appears that music
added to standard care during caesarean section under regional anaesthesia had some impact
on pulse rate at the end of maternal contact with the neonate in the intra-operative period
(MD -7.50 fewer beats per minute, 95% CI -14.08 to -0.92) and after completion of skin
suture for the caesarean section(MD -7.37 fewer beats per minute, 95% CI -13.37 to -1.37).
There was also an improvement in the birth satisfaction score (maximum possible score of
35) (MD of 3.38, 95%CI 1.59 to 5.17).Effects on other outcomes were either not significant
or not reported in the one included trial.
Authors' conclusions
The findings indicate that music during planned caesarean section under regional
anaesthesia may improve pulse rate and birth satisfaction score. However, the magnitude of
these benefits is small and the methodological quality of the one included trial is
questionable. Therefore, the clinical significance of music is unclear. More research is
needed to investigate the effects of music during caesarean section under regional
anaesthesia on both maternal and infant outcomes ,in various ethnic pregnant women, and
with adequate sample sizes.

17.Anti-D administration in pregnancy for preventing Rhesus alloimmunisation

Caroline A Crowther, Philippa Middleton


Objectives
To assess the effects of antenatal anti-D immunoglobulin on the incidence of Rhesus
Dalloimmunisation when given to Rh-negative women without anti-D antibodies.
Selection criteria
Randomised trials in Rh-negative women without anti-D antibodies given anti-D after 28
weeks of pregnancy, compared with no treatment or placebo.
Data collection and analysis
One review author extracted and double-entered data; these were checked by another
review author.
Main results
Two average to poor-quality trials, involving over 4500 women, compared anti-D
prophylaxis with no treatment. When women received anti-D at 28 and 34 weeks' gestation,
relative risk (RR) of immunisation during pregnancy was 0.42 (95% confidence interval
(CI) 0.15 to 1.17); after the birth of a Rh-positive infant the RR was 0.42 (95% CI 0.15 to
1.17); and within 12months after birth of a Rh-positive infant the RR was 0.41 (95% CI
0.16 to 1.04). While none of these differences were statistically significant, the risk
difference (RD) between anti-D and no treatment was significant (RD -0.01, 95% CI -0.01
to 0.00) suggesting reduced incidence of immunisation after anti-D prophylaxis.In the
higher dose trial (100 g; 500 international units (IU) anti-D), there was a non significant
reduction in immunisation at two to 12 months following birth of a Rh-positive infant in
women who had received anti-D (RR 0.14, 95% CI 0.02 to 1.15). However, women
receiving anti-D were significantly less likely to register a positive Kleihauer test (which
detects fetal cells in maternal blood) in pregnancy (RR 0.60, 95% CI 0.41 to 0.88) and at the
birth of a Rh-positive infant (RR 0.60, 95% CI 0.46 to 0.79). No data were available for the
risk of Rhesus D alloimmunisation in a subsequent pregnancy. No differences were seen for
neonatal jaundice.
Authors' conclusions
The risk of Rhesus D alloimmunisation during or immediately after a first pregnancy is
about1%. Administration of 100 g (500 IU) anti-D to women in their first pregnancy can
reduce this risk to about 0.2% without, to date, any adverse effects. Although unlikely to
confer benefit in the current pregnancy, fewer women may have Rhesus D antibodies in any
subsequent pregnancy, but the effects of this needs to be tested in studies of robust design.

18.Fundal pressure versus controlled cord traction as part of the active management
of the third stage of labour
Guiomar E Peña-Martí, Gabriella Comunián-Carrasco
.
Objectives
To determine the efficacy of fundal pressure versus controlled cord traction as part of the
activemanagement of the third stage of labour.
Selection criteria
We searched for published and unpublished randomised and quasi-randomised controlled
trials.
Data collection and analysis
Two review authors independently identified potential studies from the literature search and
assessed them for methodological quality and appropriateness of inclusion.
Main results
The search strategies yielded five studies for consideration of inclusion. However, none of
these studies fulfilled the requirements for inclusion in this review.
Authors' conclusions
We identified no randomised controlled trials comparing the efficacy of fundal pressure
versus controlled cord traction as part of the active management of the third stage of labour.
Hence controlled cord traction, after awaiting signs of placental separation, should remain
the third component of the active management of third stage of labour, and follow the
routine administration of a uterotonic drug and cord clamping.

19. Prostaglandins for preventing postpartum haemorrhage

A Metin Gülmezoglu, Fatu Forna, José Villar, G Justus Hofmeyr


Objectives
To assess the effects of prophylactic prostaglandin use in the third stage of labour.
Selection criteria
Randomized trials comparing a prostaglandin agent with another uterotonic or
no prophylactic uterotonic (nothing or placebo) as part of management of the third stage of
labour. The primary outcomes were blood loss 1000 ml or more and the use of additional
uterotonics.
Data collection and analysis
Two review authors independently assessed eligibility and trial quality and extracted data.
Main results
Thirty-seven misoprostol and nine intramuscular prostaglandin trials (42,621 women) were
included. Oral (seven trials, 2849 women) or sublingual misoprostol (relative risk (RR)
0.66;95% confidence interval (CI) 0.45 to 0.98; one trial, 661 women) compared to placebo
may be effective in reducing severe PPH and blood transfusion (RR 0.31; 95% CI 0.10 to
0.94; five oral misoprostol trials, 3519 women). The severe PPH analysis of oral
misoprostol trials was not totalled due to significant heterogeneity. Compared to
conventional injectable utero tonics, oral misoprostol was associated with higher risk of
severe PPH (RR 1.32; 95% CI 1.16 to 1.51; 16 trials, 29,042 women) and use of additional
uterotonics but with fewer blood transfusions (RR 0.81; 95% CI 0.64 to 1.02; 15
trials,27,858 women). Additional uterotonic data were not totalled due to heterogeneity.
Misoprostoluse is associated with significant increases in shivering and a temperature of 38
ºCelsius. There are scarce data comparing injectable prostaglandins with the conventional
injectable uterotonics on severe PPH and the use of additional uterotonics, the primary
outcomes of this review.
Authors' conclusions
Misoprostol orally or sublingually at a dose of 600 mcg shows promising results when
compared to placebo in reducing blood loss after delivery. The margin of benefit may be
affected by whether other components of management of the third stage of labour are used
or not. As side-effects are dose-related, research should be directed towards establishing the
lowest effective dose for routine use, and the optimal route of administration. Neither
intramuscular prostaglandins nor misoprostol are preferable to conventional injectable
uterotonics as part of the management of the third stage of labour especially for low-risk
women.

20.Prophylactic oxytocin for the third stage of labour

Amanda M Cotter, Amen Ness, Jorge E Tolosa


Objectives
To examine the effect of oxytocin given prophylactically in the third stage of labour on
maternaland neonatal outcomes.
Selection criteria
Randomised or quasi-randomised controlled trials including pregnant women anticipating
avaginal delivery where oxytocin was given prophylactically for the third stage of labour.
Data collection and analysis
The review authors independently assessed trial quality and extracted data. Analysis was by
intention to treat. Subgroup analyses were based on extent of selection bias, oxytocin in the
context of active or expectant management of the third stage, and timing of administration.
Results are presented as relative risks, and weighted mean difference, both with 95%
confidence intervals using a fixed-effect model.
Main results
Fourteen trials are included. In seven trials involving over 3000 women, prophylactic
oxytocin showed benefits (reduced blood loss (relative risk (RR) for blood loss greater than
500 ml 0.50;95% confidence interval (CI) 0.43 to 0.59) and need for therapeutic oxytocics
(RR 0.50; 95% CI0.39 to 0.64) compared to no uterotonics. In six trials involving over 2800
women, there was little evidence of differential effects for oxytocin versus ergot alkaloids,
except that oxytocin was associated with fewer manual removals of the placenta (RR 0.57;
95% CI 0.41 to 0.79), and with the suggestion of less raised blood pressure (RR 0.53; 95%
CI 0.19 to 1.52) than with ergot alkaloids.In five trials involving over 2800 women, there
was little evidence of a synergistic effect of adding oxytocinto ergometrine versus
ergometrine alone.
Authors' conclusions
Oxytocin appears to be beneficial for the prevention of postpartum haemorrhage. However,
thereis insufficient information about other outcomes and side-effects hence it is difficult to
beconfident about the trade-offs for these benefits. There seems little evidence in favour of
ergotalkaloids alone compared to either oxytocin alone, or to ergometrine-oxytocin, but the
data aresparse. More trials are needed in domiciliary deliveries in developing countries,
which shoulder most of the burden of third stage complications.

21. Position in the second stage of labour for women without epidural anaesthesia

Janesh K Gupta, G Justus Hofmeyr, Rebecca MD Smyth

Objectives
To assess the benefits and risks of the use of different positions during the second stage of
labour (i.e. from full dilatation of the cervix).
Selection criteria
Trials that used randomised or quasi-randomised allocation and appropriate follow up and
compared various positions assumed by pregnant women during the second stage of labour.
Data collection and analysis
We independently assessed the trials for inclusion and extracted the data.
Main results
Results should be interpreted with caution as the methodological quality of the 20 included
trials(6135 participants) was variable. Use of any upright or lateral position, compared with
supine or lithotomy positions, was associated with: reduced duration of second stage of
labour (9 trials:mean 4.28 minutes, 95% confidence interval (CI) 2.93 to 5.63 minutes) -
this was largely due to a considerable reduction in women allocated to the use of the birth
cushion; a small reduction in assisted deliveries (19 trials: relative risk (RR) 0.80, 95% CI
0.69 to 0.92); a reduction in episiotomies (12 trials: RR 0.83, 95% CI 0.75 to 0.92); an
increase in second degree perineal tears (11 trials: RR 1.23, 95% CI 1.09 to 1.39); increased
estimated blood loss greater than 500ml (11 trials: RR 1.63, 95% CI 1.29 to 2.05); reduced
reporting of severe pain during second stage of labour (1 trial: RR 0.73, 95% CI 0.60 to
0.90); fewer abnormal fetal heart rate patterns(1 trial: RR 0.31, 95% CI 0.08 to 0.98).

Authors' conclusions
The tentative findings of this review suggest several possible benefits for upright posture,
with the possibility of increased risk of blood loss greater than 500 ml. Women should be
encouraged to give birth in the position they find most comfortable. Until such time as the
benefits and risks of various delivery positions are estimated with greater certainty,
when methodologically stringent trials' data are available, women should be allowed to
make informed choices about the birth positions in which they might wish to assume for
delivery of their babies.

22. Placental cord drainage after spontaneous vaginal delivery as part of the
management of the third stage of labour

Hora Soltani, Fiona Dickinson, Ian M Symonds


Objectives
The objective of this review was to assess the specific effects of placental cord drainage on
thethird stage of labour, with or without the prophylactic use of oxytocics.
Selection criteria
Randomised trials involving placental cord drainage as a variable within the package
of interventions as part of the management of the third stage of labour.
Data collection and analysis
Two review authors independently assessed the quality of trials and extracted data.
Main results
Two studies met our inclusion criteria in terms of quality and relevance. Cord drainage
could impact the third stage of labour as the results show a statistically significant reduction
in the length of third stage of labour (one trial, n = 147, weighted mean difference (minutes)
-5.46, 95%confidence interval (CI) -8.02 to -2.90). In the incidence of retained placenta at
30 minutes after birth (one trial, n = 477, relative risk 0.28, 95% CI 0.10 to 0.73) a
significant difference was found, but this should be interpreted with caution due to potential
intervention bias.
Authors' conclusions
It is difficult to draw conclusions from such a small number of studies, especially where the
review outcomes were presented in a variety of formats. However, there does appear to be
some potential benefit from the use of placental cord drainage in terms of reducing
the length of the third stage of labour. More research is required to investigate the impact of
cord drainage on the management of the third stage of labour
23.Antenatal breast examination for promoting breastfeeding

Sue J Lee, Jane Thomas


Objectives

To determine the effect of antenatal breast examination(s) on the initiation of breastfeeding.


Selection criteria
All randomised controlled trials of the effects of antenatal breast examination, with a
concurrent comparison group.
Data collection and analysis
Two review authors independently assessed trial quality and extracted data.
Main results
We identified no randomised controlled trials.
Authors' conclusions
Ideally, policies that govern the care of pregnant women should be evidence based. There is
nodoubt that breastfeeding is beneficial for both mother and infant. However, there is
no evidence to support the notion that antenatal breast examinations are effective in
promoting breastfeeding,nor any evidence on other potential effects of antenatal breast
examination, such as the detection of breast anomalies or satisfaction with care.
24.Interventions for promoting the initiation of breastfeeding

Lisa Dyson, Felicia M McCormick, Mary J Renfrew


Objectives
To evaluate the effectiveness of interventions which aim to encourage women to breastfeed
in terms of changes in the number of women who start to breastfeed.
Selection criteria
Randomised controlled trials, with or without blinding, of any breastfeeding
promotionintervention in any population group except women and infants with a specific
health problem.
Data collection and analysis
One review author independently extracted data and assessed trial quality, checked by a
second author. We contacted investigators to obtain missing information.
Main results
Eleven trials were included. Statistical analyses were conducted on data from eight trials
(1553women). Five studies (582 women) on low incomes in the USA with typically low
breast feeding rates showed breastfeeding education had a significant effect on increasing
initiation rates compared to standard care (risk ratio (RR) 1.57, 95% confidence interval
(CI) 1.15 to 2.15, P =0.005). Subgroup analyses showed that one-to-one, needs-based,
informal repeat education sessions and generic, formal antenatal education sessions are
effective in terms of an increase in breastfeeding rates among women on low incomes
regardless of ethnicity and feeding intention. Needs-based, informal peer support in the
antenatal and postnatal periods was also shown to be effective in one study conducted
among Latina women who were considering breastfeeding in the USA (RR 4.02, 95% CI
2.63 to 6.14, P < 0.00001).
Authors' conclusions
This review showed that health education and peer support interventions can result in some
improvements in the number of women beginning to breastfeed. Findings from these
studies suggest that larger increases are likely to result from needs-based, informal repeat
education sessions than more generic, formal antenatal sessions. These findings are based
only on studies conducted in the USA, among women on low incomes with varied ethnicity
and feeding intention, and this raises some questions regarding generalisability to
other settings.
25. Methods of milk expression for lactating women

Genevieve E Becker, Felicia M McCormick, Mary J Renfrew


Objectives
To assess acceptability, effectiveness, safety, effect on milk composition, bacterial
contamination of milk and cost implications of a range of methods of milk expression,
including hand expression and manual, battery and electric pumps.
Selection criteria
Randomised and quasi-randomised controlled trials that compared one method or technique
of milk expression or pumping with other(s), at any time after birth, and cross-over trials
that commenced at least 28 days after birth.
Data collection and analysis
Two authors independently assessed trial quality and extracted data. We sought additional
in formation from the trial authors.
Main results
Twelve studies met the inclusion criteria of which six (397 mothers) provided data that
could be used in the analyses. Compared with hand expression, one study found a
significantly greater total volume of milk expressed over six days both with the electrical
pump (373.10 ml, 95% confidence interval (CI) 161.09 to 585.11), and with the foot-
operated pump (212.10 ml, 95% CI9.39 to 414.81); however, the difference found between
the foot pump and the electric pump was not significant. Mothers provided with a relaxation
tape produced a greater volume of milk atone expression than women not provided with the
tape (34.70 ml, 95% CI 9.51 to 59.89).Simultaneous pumping took less time than sequential
pumping in one study (3.50 hours/week,95% CI 1.39 to 5.61). No evidence of difference
was found in volume with simultaneous or sequential pumping, or for milk contamination,
breastfeeding at discharge, fat content of milk, serum prolactin by method of pumping.
Maternal satisfaction, adverse effects on mothers and economic effects of interventions
were poorly reported.
Authors' conclusions
Mothers appear to obtain greater total volumes of milk in six days after birth using the
electric or foot powered pump tested compared to hand expression, and a greater volume at
one expression during the second week when provided with a relaxation tape. Simultaneous
pumping takes less time compared to sequential pumping. Further research with larger
numbers and more comprehensive reporting is needed, and mothers' reasons for expressing
linked to their evaluation of effectiveness rather than market-led research on equipment
performance.

26.Interventions for nausea and vomiting in early pregnancy

David Jewell, GaviN Young


Objectives

Selection criteria
Randomised trials of any treatment for nausea and/or vomiting in early pregnancy.
Data collection and analysis
Two reviewers assessed the trial quality and extracted the data independently.
Main results
Twenty-eight trials met the inclusion criteria. For milder degrees of nausea and vomiting,
21trials were included. These trials were of variable quality. Nausea treatments were:
different antihistamine medications, vitamin B6 (pyridoxine), the combination
tablet Debendox (Bendectin), P6 acupressure and ginger. For hyperemesis gravidarum,
seven trials were identified testing treatments with oral ginger root extract, oral or injected
corticosteroids or injected adrenocorticotropic hormone (ACTH), intravenous diazepam and
acupuncture. Based on12 trials, there was an overall reduction in nausea from anti-emetic
medication (odds ratio 0.16,95% confidence interval 0.08 to 0.33).
Authors' conclusions
Anti-emetic medication appears to reduce the frequency of nausea in early pregnancy.
There is some evidence of adverse effects, but there is very little information on effects on
fetal outcomes from randomised controlled trials. Of newer treatments, pyridoxine (vitamin
B6) appears to be more effective in reducing the severity of nausea. The results from trials
of P6 acupressure areequivocal. No trials of treatments for hyperemesis gravidarum show
any evidence of benefit. Evidence from observational studies suggests no evidence of
teratogenicity from any of these treatments.

27. Interventions for heartburn in pregnancy

Therese Dowswell, James P Neilson


Objectives
To assess the effect of interventions to relieve heartburn in pregnancy.
Selection criteria
We included randomised controlled trials evaluating interventions to relieve heartburn.
Data collection and analysis
We assessed eligibility for inclusion and extracted data independently.
Main results
Three studies were eligible for inclusion, together they included a total of 286 women. All
three were placebo controlled trials, each examining a different medication to relieve
heartburn(intramuscular prostigmine, an antacid preparation and an antacid plus ranitidine).
All three produced positive findings in favour of the intervention groups. It was not possible
to pool findings from studies to produce an overall treatment effect.
Authors' conclusions
There was little information to draw conclusions on the overall effectiveness of
interventions to relieve heartburn in pregnancy.

28.Interventions for preventing and treating pelvic and back pain in pregnancy

Victoria Pennick, Gavin Young


Objectives
To assess the effects of interventions for preventing and treating back and pelvic pain
in pregnancy.
Selection criteria
Randomised controlled trials of any treatment to prevent or reduce the incidence or severity
of back or pelvic pain in pregnancy.
Data collection and analysis
Two authors independently assessed trial quality and extracted data.
Main results
We found no studies dealing specifically with prevention of back or pelvic pain. We
included eight studies (1305 participants) that examined the effects of adding various
pregnancy-specific exercises, physiotherapy, acupuncture and pillows to usual prenatal
care.For women with low-back pain, participating in strengthening exercises, sitting pelvic
tilt exercises (standardised mean difference (SMD) -5.34; 95% confidence interval (CI) -
6.40 to -4.27), and water gymnastics reduced pain intensity and back pain-related sick leave
(relative risk (RR) 0.40; 95% CI 0.17 to 0.92) better than usual prenatal care alone.
The specially-designed Ozzlo pillow was more effective than a regular one in relieving back
pain(RR 1.84; 95% CI 1.32 to 2.55), but is no longer commercially available. Both
acupuncture and stabilising exercises relieved pelvic pain more than usual prenatal care.
Acupuncture gave more relief from evening pain than exercises. For women with both
pelvic and back pain, in one study, acupuncture was more effective than physiotherapy in
reducing the intensity of their pain; stretching exercises resulted in more total pain relief
(60%) than usual care (11%); and 60% of those who received acupuncture reported less
intense pain, compared to 14% of those receiving usual prenatal care. Women who received
usual prenatal care reported more use of analgesics, physical modalities and sacroiliac belts.
Authors' conclusions
All but one study had moderate to high potential for bias, so results must be viewed
cautiously. Adding pregnancy-specific exercises, physiotherapy or acupuncture to usual
prenatal care appears to relieve back or pelvic pain more than usual prenatal care alone,
although the effects are small. We do not know if they actually prevent pain from starting in
the first place. Water gymnastics appear to help women stay at work. Acupuncture shows
better results compared to physiotherapy
29. Interventions for treating constipation in pregnancy

David Jewell, Gavin Young


Objectives
The objective of this review was to assess the effects of different methods for treating
constipation in pregnancy.
Selection criteria
Randomised trials of any treatment for constipation in pregnancy.
Data collection and analysis
Trial quality assessments and data extraction were done independently by two reviewers.
Main results
Two suitable trials were identified. Fibre supplements increased the frequency of
defecation(odds ratio 0.18, 95% confidence interval 0.05 to 0.67), and lead to softer stools.
Stimulant laxatives are more effective than bulk-forming laxatives (odds ratio 0.30, 95%
confidence interval 0.14 to 0.61), but may cause more side effects.
Authors' conclusions
Dietary supplements of fibre in the form of bran or wheat fibre are likely to help women
experiencing constipation in pregnancy. If the problem fails to resolve, stimulant laxatives
are likely to prove more effective.
EVIDENCE BASED PRACTICES IN NEONATALOGY

1) Effect of timing of umbilical cord clamping of term infants on maternal and


neonatal outcomes

Susan J McDonald, Philippa Middleton


Objectives
To determine the effects of different policies of timing of cord clamping at delivery of
the placenta on maternal and neonatal outcomes.
Selection criteria
Randomised controlled trials comparing early and late cord clamping.
Data collection and analysis
Two review authors independently assessed trial eligibility and quality and extracted data.
Main results
We included 11 trials of 2989 mothers and their babies. No significant differences between
early and late cord clamping were seen for postpartum haemorrhage or severe postpartum
haemorrhage in any of the five trials (2236 women) which measured this outcome (relative
risk (RR) for postpartum haemorrhage 500 mls or more 1.22, 95% confidence interval (CI)
0.96 to1.55). For neonatal outcomes, our review showed both benefits and harms for late
cord clamping. Following birth, there was a significant increase in infants needing
phototherapy for jaundice(RR 0.59, 95% CI 0.38 to 0.92; five trials of 1762 infants) in the
late compared with early clamping group. This was accompanied by significant increases in
newborn haemoglobin levels in the late cord clamping group compared with early cord
clamping (weighted mean difference2.17 g/dL; 95% CI 0.28 to 4.06; three trials of 671
infants), although this effect did not persist past six months. Infant ferritin levels remained
higher in the late clamping group than the early clamping group at six months.
Authors' conclusions
One definition of active management includes directions to administer an uterotonic with
birth of the anterior shoulder of the baby and to clamp the umbilical cord within 30-60
seconds of birth of the baby (which is not always feasible in practice). In this review
delaying clamping of the cord for at least two to three minutes seems not to increase the risk
of postpartum haemorrhage. In addition, late cord clamping can be advantageous for the
infant by improving iron status which may be of clinical value particularly in infants where
access to good nutrition is poor,although delaying clamping increases the risk of jaundice
requiring phototherapy.

2.Prophylactic animal derived surfactant extract for preventing morbidity and


mortality in preterm infants

Roger Soll Eren Özek

Objectives
To assess the effect of prophylactic intratracheal administration of animal derived surfactant
extract on mortality, broncho pulmonary dysplasia (BPD) and other morbidities in preterm
newborns at risk for developing RDS. Subgroup analysis were planned according to the
specific surfactant product and the degree of prematurity.
Selection criteria
Randomized or quasi-randomized controlled trials that compared the effect of
prophylacticanimal derived surfactant extract administration (surfactant obtained from
human, porcine or bovine sources, either modified with additional phospholipids or not)
administered to high risk preterm newborns at or shortly after birth in order to prevent
RDS, mortality and other complications of prematurity.
Data collection and analysis
Data extraction and analysis was done in accordance with the standards of the CNRG.
Main results
All nine of the included studies note an initial improvement in respiratory status and a
decrease in the risk of RDS in infants who receive prophylactic animal derived surfactant
extract. The meta-analysis supports a decrease in the risk of pneumothorax (typical relative
risk 0.40, 95% CI0.29, 0.54; typical risk difference -0.12, 95% CI -0.16, -0.09), a decrease
in the risk pulmonary interstitial emphysema (PIE) (typical relative risk 0.46, 95% CI
0.36, 0.59; typical risk difference-0.16, 95% CI -0.21, -0.11), a decrease in the risk of
neonatal mortality (typical relative risk 0.60,95% CI 0.47, 0.77; typical risk difference -
0.07, 95% CI -0.12, -0.03), and a decrease in the risk of BPD or death (typical relative risk
0.80, 95% CI 0.72, 0.88; typical risk difference -0.10, 95%CI -0.16, -0.04). No differences
are reported in the risk of intra ventricular hemorrhage, patent ductus arteriosus,
necrotizing enterocolitis or retinopathy of prematurity. Few data are available on long-term
follow-up of treated infants.
Authors' conclusions
Prophylactic intratracheal administration of animal derived surfactant extract to
infants judged to be at risk of developing respiratory distress syndrome has been
demonstrated to improve clinical outcome. Infants who receive prophylactic animal derived
surfactant extract have a decreased risk of pneumothorax, a decreased risk of PIE, a
decreased risk of mortality, and a decreased risk of BPD or death.

3. Continuous nasogastric milk feeding versus intermittent bolus milkfeeding for


premature infants less than 100 grams

Shahirose S Premji, Lorraine Chessell


Objectives
To examine the evidence regarding the effectiveness of continuous vs. intermittent
bolusnasogastric milk feeding in premature infants less than 1500 grams.

Selection criteria
Randomized and quasi-randomized clinical trials comparing continuous vs. intermittent
bolusnasogastric milk feeding in premature infants less than 1500 grams.
Data collection and analysis
Two review authors independently assessed all trials for relevance and methodologic
quality.The standard methods of the Cochrane Neonatal Review Group were used to extract
data.
Main results
Overall, the seven included trials, involving 511 infants, found no differences in time to
achieve full enteral feeds between feeding methods (weighted mean difference (WMD) 2
days; 95% CI -0.3, 3.9) . In the subgroup analysis of those studies comparing continuous
nasogastric vs.intermittent bolus nasogastric milk feedings the findings remained
unchanged (WMD 2 days,95% CI -0.4, 4.1). There was no significant difference in somatic
growth and incidence of NEC between feeding methods irrespective of tube placement. One
study noted a trend toward more apneas during the study period in infants fed by the
continuous tube feeding method compared tothose fed by intermittent feedings delivered
predominantly by orogastric tube placements [mean difference (MD) 14.0 apneas during
study period; 95% CI -0.2, 28.2]. In subgroup analysis based on weight groups, one study
suggested that infants less than 1000 grams and 1000 - 1250 grams birth weight gained
weight faster when fed by the continuous nasogastric tube feeding method compared to
intermittent nasogastric tube feeding method (MD 2.0 g/day; 95% CI 0.5, 3.5; MD2.0
g/day; 95% CI 0.2, 3.8, respectively). A trend toward earlier discharge for infants less
than1000 grams birth weight fed by the continuous tube feeding method compared to
intermittent nasogastric tube feeding method (MD -11 days; 95% CI -21.8, -0.2).
Authors' conclusions
Small sample sizes, methodologic limitations, inconsistencies in controlling variables that
may affect outcomes, and conflicting results of the studies to date make it difficult to make
universal recommendations regarding the best tube feeding method for premature infants
less than 1500grams. The clinical benefits and risks of continuous vs. intermittent
nasogastric tube milk feeding cannot be reliably discerned from the limited information
available from randomized trials to date.

4. Nasal versus oral route for placing feeding tubes in preterm orlow birth weight
infants

Judith Hawes, Peter McEwan, William McGuire


Objectives

To determine the effect of nasal compared with oral placement of enteral feeding tubes on
feeding, growth and development, and the incidence of adverse consequences in preterm or
low birth weight infants.
Selection criteria
Randomised or quasi-randomised controlled trials that compared the use of the nasal versus
oral route for placing enteral feeding tubes in preterm or low birth weight infants.
Data collection and analysis
The standard methods of the Cochrane Neonatal Review Group were used, with separate
evaluation of trial quality and data extraction by two authors. Data synthesis using a fixed
effects model and reporting typical relative risk, typical risk difference and weighted mean
difference was planned.
Main results
Two small randomised trials were identified. Only one trial reported data on the pre-
specified primary outcomes for this review. This trial found no evidence of effect on the
time taken to establish enteral feeding nor the time taken to regain birth weight. However,
the trial was underpowered (N= 46) to exclude modest effect sizes.
Authors' conclusions
There are insufficient data available to inform practice. A large randomised controlled trial
is required to determine if the use of naso- vs. oro-enteric feeding tubes affects feeding,
growth and development, and the incidence of adverse consequences in preterm or low birth
weight infants.

5.Cot-nursing versus incubator care for preterm infants

Peter H Gray, Vicki Flenady


Objectives
Among preterm infants allocated to cot-nursing vs incubator care in neonatal period, to
assess effects on their temperature control and weight gain.
Selection criteria
All trials using random or quasi-random patient allocation in which infants receiving care in
standard newborn cots were compared to infants managed in a conventional air heated
incubator.
Data collection and analysis
The authors independently assessed trial quality and extracted data for the primary
outcomes of temperature control and weight gain. Meta-analysis was conducted using a
fixed effects model. Results are presented as relative risk (RR) for categorical data
and mean difference (MD) and weighted mean differences (WMD) for data measured on a
continuous scale.
Main results
Nine potential studies were identified of which four, involving 173 babies, were included
in this review. When compared to incubator care, cot-nursing resulted in a statistically
significantly higher mean body temperature (MD 0.30 degrees C; 95% CI 0.10, 0.50, one
trial) and a decrease in proportion of infants not breast feeding at hospital discharge (RR
0.52; 95% CI 0.28, 0.94, two trials, 77 infants). No statistically significant difference was
shown in weight gain, reported by two trials involving 69 infants. The comparison of cot-
nursing using a heated water-filled mattress versus incubator care, which included four
trials and a total of 149 infants, produced similar results. Cot-nursing with warming of
the nursery resulted in statistically significantly smaller weight gain during week one
compared to the incubator group in one trial that involved 49 infants (MD -5.90 g/kg/day;
95% CI -11.13, -0.67) with no significant difference found for weeks two and three.
Authors' conclusions
Due to the small numbers of trials included and infants studied, and the resulting
imprecision in the measures of effect for all outcomes, the review does not give a clear
indication for the role of cot-nursing for preterm infants. Further assessment of the role of
cot nursing for preterm infants using randomised controlled trials is necessary.

6.Kangaroo mother care to reduce morbidity and mortality in low birth weight infants
Agustin Conde-Agudelo, José M Belizán
Objectives
To determine whether there is evidence to support the use of KMC in LBW infants as
analternative to conventional care after the initial period of stabilization with conventional
care.
Selection criteria
Randomized trials comparing KMC and conventional neonatal care in LBW infants.
Data collection and analysis
Trial quality was assessed and data were extracted independently by two reviewers.
Statistical analysis was conducted using the standard Cochrane Collaboration methods.
Main results
Three studies, involving 1362 infants, were included. All the trials were conducted in
developing countries. The studies were of moderate to poor methodological quality. The
most common shortcomings were in the areas of blinding procedures for those who
collected the out comes measures, handling of drop outs, and completeness of follow-up.
The great majority of results consist of results of a single trial. KMC was associated with
the following reduced risks :nosocomial infection at 41 weeks' corrected gestational age
(relative risk 0.49, 95% confidence interval 0.25 to 0.93), severe illness (relative risk 0.30,
95% confidence interval 0.14 to 0.67),lower respiratory tract disease at 6 months follow-up
(relative risk 0.37, 95% confidence interval0.15 to 0.89), not exclusively breastfeeding at
discharge (relative risk 0.41, 95% confidence interval 0.25 to 0.68), and maternal
dissatisfaction with method of care (relative risk 0.41, 95%confidence interval 0.22 to 0.75).
KMC infants had gained more weight per day by discharge (weighted mean difference 3.6
g/day, 95% confidence interval 0.8 to 6.4). Scores on mother's sense of competence
according to infant stay in hospital and admission to NICU were better in KMC than in
control group (weighted mean differences 0.31 [95% confidence interval 0.13 to0.50] and
0.28 [95% confidence interval 0.11 to 0.46], respectively). Scores on mother's perception of
social support according to infant stay in NICU were worse in KMC group than in control
group (weighted mean difference -0.18 (95% confidence interval -0.35 to -
0.01).Psychomotor development at 12 months' corrected age was similar in the two groups.
There was no evidence of a difference in infant mortality. However, serious concerns about
the methodological quality of the included trials weaken credibility in these findings.
Authors' conclusions
Although KMC appears to reduce severe infant morbidity without any serious deleterious
effect reported, there is still insufficient evidence to recommend its routine use in LBW
infants. Well designed randomized controlled trials of this intervention are needed.

7. Radiant warmers versus incubators for regulating body temperature in newborn


infants

Vicki Flenady, Paul G Woodgate


Objectives
To assess the effects of radiant warmers versus incubators on neonatal fluid and
electrolyte balance, morbidity and mortality.
Selection criteria
Randomised or quasi-randomised trials in which radiant warmers were compared to
incubators ina neonatal population.
Data collection and analysis
Independent data extraction and quality assessment of included trials was conducted by the
authors. Data were analysed using relative risk (RR) and weighted mean difference
(WMD).Results are presented with 95% confidence intervals. Meta-analysis was
undertaken using a fixed effect model.
Main results
Eight studies are included in this review; six employed a crossover design. In the overall
comparison of radiant warmers vs incubators, radiant warmers caused a statistically
significant increase in insensible water loss (IWL) [WMD 0.94g/Kg/day (95% CI 0.47,
1.41)] and a trend towards increased oxygen consumption which was not statistically
significant [WMD0.27mL/kg/min (95% CI -0.09, 0.63)]. Due to small numbers, effects on
important clinical outcomes could not be adequately assessed. A comparison of
radiant warmers with heat shields vs incubators without heat shields showed a trend for
increased IWL in the radiant warmer group, which was not statistically significant.
No difference was shown in oxygen consumption.
Authors' conclusions
Radiant warmers result in increased IWL compared to incubators. This needs to be
taken intoaccount when calculating daily fluid requirements. The results of this review do
not provide sufficient evidence concerning effects on important outcomes to guide clinical
practice. Further randomised controlled trials are required to assess the effects of radiant
warmers versus incubators in neonatal care on important short and long term outcomes,
with particular attention to extremely low birth weight infants in the early neonatal period.

8.Fibreoptic phototherapy for neonatal jaundice

John F. Mills, David Tudehope


Objectives
To evaluate the efficacy of fibreoptic phototherapy.
Selection criteria
Randomised or quasi-randomised controlled trials evaluating the efficacy of
fibreoptic phototherapy in the management of newborn infants with hyperbilirubinaemia.
Data collection and analysis
Thirty-one studies were identified of which 24 met inclusion criteria. They evaluated the
efficacyof fibreoptic phototherapy in a number of different clinical situations and patient
populations.
Main results
Fibreoptic phototherapy was more effective at lowering SBR than no treatment but less
effective than conventional phototherapy (percentage change in SBR after 24 hours of
treatment: WMD -10.7%, 95%CI -18.14, -3.26 and WMD 3.59%, 95%CI 1.27, 5.92
respectively). Fibreoptic phototherapy was equally as effective as conventional
phototherapy in preterm infants and when two fibreoptic devices were used simultaneously
(change in SBR after 24 hours of treatment:WMD 1.7%, 95%CI -2.65, 6.05 and change in
SBR per day over whole treatment period: WMD2.82%, 95%CI -1.84, 7.48 respectively). A
combination of fibreoptic and conventional phototherapy was more effective than
conventional phototherapy alone (duration of phototherapy: WMD -12.51 hr, 95%CI -
16.00, -9.02, meta-analysis affected by heterogeneity). No conclusion can be made on the
superiority of one fibreoptic device over another as the twostudies comparing them (one
favouring Bili Blanket, the other finding no difference) did notcontain a common outcome
measure.
Authors' conclusions
Fibreoptic phototherapy has a place in the management of neonatal hyperbilirubinaemia. It
is probably a safe alternative to conventional phototherapy in term infants with
physiological jaundice. No trials have been identified which support the widely-held view
that fibreoptic devices interfere less with infant care or impact less on parent-child bonding.

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