Rajiv Gandhi University of Health Sciences Karnataka

Bangalore
Annexure II: Proforma For Registration Of Subject
For Dissertation

1. Name of the candidate

And address

Dr. Vinutha.Sasalatti
PG Resident,
Department Of Obstetrics and
Gynaecology
St. Johns Medical College and Hospital
Bangalore 34

2. Name of the Institution

St. Johns Medical College and Hospital

Bangalore 34

3. Course
subject

of

study

and

M.S. Obstetrics and Gynaecology

4. Date of admission to
course

01.06.2013

5. Title of the topic

A comparative study to evaluate the predictability

of perinatal outcome by digitalised fetal
cardiotacogram(including power spectral
analysis)with conventional cardiotocography
Dr. Sheela CN

6. Name and designation

of the guide

Professor and Head of Department,

Department
Gynaecology,

of

Obstetrics

&

St. Johns Medical College,

Bangalore- 560 034.
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6.1 Need for the study:

Oxygen supply from the mother to her fetus may be endangered during delivery. In the worst
case it may lead to fetal cerebral damage or death. Intrapartum acidosis may also lead to
meconium aspiration and metabolic disturbances and, later in life, to cognitive dysfunction1.
To prevent morbidity, it is essential to detect fetal acidosis.
The most widely used method for monitoring fetal well-being during delivery is
cardiotocography (CTG), but CTG is non-specific with regard to identification of fetal
acidosis. Since visual interpretation of CTG is subjective, there is a high inter- and
intraobserver variability in how fetal heart rate (FHR) tracings are viewed by clinicians2.
Continuous CTG monitoring may also lead to an increased numbers of cesarean sections and
instrumental vaginal deliveries3.
Fetal scalp blood sampling is the gold standard for identification of intrapartum fetal acidosis,
and is used alongside CTG. However, fetal blood sampling is an invasive procedure and
requires rupture of membranes. Furthermore, it is not free of complications, and fetal scalp
infections and haemorrhages may ensue4.
Recently, ST analysis of the fetal electrocardiogram (STAN) has been used to assess fetal
wellbeing during delivery. Compared to fetal scalp blood sampling, ST analysis yields
continuous information and is more convenient for the parturient. However, STAN is also
dependent on subjective interpretation of the CTG. Hence there is a need to evolve more
objective information in fetal responses to hypoxia.
During oxygen deficiency, the autonomic nervous system (ANS) is activated, and this causes
changes in the control of FHR5. In an experimental study, occlusion of umbilical cord caused
a decrease in FHR and an increase in short-term fetal heart rate variability (FHRV) in fetuses,
together with a slight decrease in pH. Increased FHRV is thought to be an important sign of
adequate circulatory adaptation in the compromised fetus6. A frequency specific assessment
of FHRV by power spectral analysis may be used to monitor features of fetal autonomic
cardiac control7. Spectral analysis provides a tool for quantifying small changes in FHRV that
remain undetected if heart rate tracings are only interpreted visually. And specific frequency
components of heart rate fluctuations thus obtained could be used to predict fetal distress
much earlier.
Thus present study will evaluate the utility of digitalised fetal cardiotacogram (power spectral
analysis) in comparison with the conventional method of evaluation in predictability of
perinatal outcome.

6.2 AIMS AND OBJECTIVES:

1) To evaluate digitalized fetal cardiotacogram (power spectral analysis) as a tool for
detection of intrapartum fetal hypoxia in comparison with conventional cardiotocography
2) To compare the predictive value of digitalised fetal cardiotacogram (power spectral
analysis) with conventional cardiotocography with respect to adverse perinatal outcome.
6.3 REVIEW OF LITERATURE:
De Souza et al8, studied the relation between fetal distress and the subsequent condition at
birth in 2791 pregnancies. The study showed reduction in birth scores was greater in the
presence of meconium stained liquor and abnormal fetal heart rate than meconium stained
liquor alone and the latter being an early sign of fetal distress .
James A Low et al9, conducted a study to determining the contribution of antenatal asphyxia
to brain damage in the neonate. The study found a prevalence of fetal asphyxia at delivery at
term is 25 per 1000 live births of whom 15% are moderate or severe; and in the preterm, 73
per 1000 live births of whom 50% are moderate or severe. They found that much of the brain
damage observed in the newborn reflects events that occurred before delivery and newborn
asphyxia particularly in the preterm newborn, may contribute to the brain damage accounting
for deficits in surviving children.
Joel D Larma et al10, conducted a study to determine efficacy of intrapartum electronic fetal
heart rate monitoring and the identification of metabolic acidosis and hypoxic-ischemic
encephalopathy. The study identified fetuses with hypoxic-ischemic encephalopathy had
significant increases in bradycardia(15.4%, 98.9%, 66.7%, 89.4%), decreased
variability(53.8%, 79.8%, 26.9%, 92.6%), nonreactivity(92.3%, 61.7%, 2.7%,82.9%)and
7.7%, 98.9%, 50.0%, and 88.6%, respectively, for all 3 abnormalities combined but no
difference in late or variable decelerations.( sensitivity, specificity , positive predictive value
and negative predictive value)

James A Low et al11, studied to evaluate the predictive value of electronic fetal monitoring for
intrapartum fetal asphyxia with metabolic acidosis. The study showed a sensitivity of
93%, positive predictive value of 18.1%, and the negative predictive value of 99.5% and
concluded that with careful interpretation, predictive FHR patterns can be a useful
screening test for fetal asphyxia.
Hafzir Rahman et al12, conducted a cross sectional study to evaluate the role of admission
cardiotocography in intrapartum patients in detecting fetal hypoxia. The results of the
admission test were reactive in 82.38%, equivocal in 10.22%, and ominous in 7.38%
women and the incidence of intrapartum fetal distress were 6.9% , 39.9% and 84.6%
respectively. They concluded that admission cardiotocography as a simple screening tool
to detect fetal distress already present or likely to develop and prevent unnecessary delay
in intervention.
Dellinger et al13, conducted a study to test the ability of a clearly defined classification system
for electronic fetal heart rate monitoring to predict early neonatal outcome among the 898
patients. 627 (70%) had tracings classified as normal, 263 (29%) had tracings classified as
fetal stress, and 8 (1%) had tracings classified as fetal distress. There was a significant
worsening of neonatal outcome across these 3 groups with regard to depressed Apgar scores 1
minute (5.1%, 18.3%, and 75.0%; P <.05), depressed Apgar scores at 5 minutes (1.0%, 3.8%,
and 37.5%; P <.05), and admission to the neonatal intensive care unit (5.6%, 10.6%, and
37.5%; P <.05). There was also a progressive worsening of cord blood pH (7.27 +/- 0.06, 7.21
+/- 0.08, and 7.06 +/- 0.14; P <.05), a progressive increase in PCO2 (53.39 +/- 8.34 mm Hg,
58.51 +/- 10.55 mm Hg, and 78.31 +/- 20.35 mm Hg; P <.05), and a progressive decline in
base excess (-3.18 +/- 2.02 mEq/L, -5. 11 +/- 3.11 mEq/L, and -9.07 +/- 4.59 mEq/L; P <.05).
Thus concluded that this simple classification system for interpreting fetal heart rate tracings
accurately predicts normal outcomes for fetuses as well discriminating fetuses in true distress
and also identifies an intermediate group of fetuses with a condition labeled fetal stress who
might benefit from additional evaluation and possibly from expeditious delivery.
Saila M, Siira et al14, conducted a prospective clinical study to assess
whether intrapartum acidosis affects specific components of fetal heart
rate variability. The spectral bands of fetal heart rate variability were
compared between the acidotic and control fetuses. The study found that during
the last hour of monitoring, baseline fetal heart rate gradually decreased, whereas total, highfrequency fetal heart rate variability initially increased but then, near the delivery, decreased
in the acidotic fetuses when compared with the controls, low-to-high frequency ratio was
greater in the acidotic group during the whole study period (P 0.002),cord artery pH was
inversely associated with total fetal heart rate variability (P < 0.001), low-frequency fetal
heart rate variability (P < 0.001) and low-to-high frequency ratio (P 0.004). Thus
concluding that marked fetal acidosis was associated with frequency-specific changes in fetal
heart rate.
Saiira et al15, conducted a study to determine whether intra partum fetal acidosis can be
detected by analyzing spectral powers of FHRV. The study found that intrapartum hypoxia
increased the spectral powers of FHR and as fetal acidosis deepened, FHRV decreased and
that a change in excess of 30% of the low-to-high frequency ratio of FHRV was associated
with fetal metabolic acidosis. The result suggests that a decrease in the spectral powers of
FHRV signals concerns the fetal wellbeing.
4

7 MATERIAL AND METHODS:

7.1 SOURCE OF DATA: The main source of data for this study is any women in active
labour with singleton pregnancy >34 weeks in cephalic presentation admitted in the labour
room at St Johns Medical College Hospital
SAMPLE SIZE: Considering the correlation with normalised high frequency power of 0.3
with 80% power, 5% level of significance 79 subjects are needed.
STASTICAL ANALYSIS:
Descriptive statistics will be reported using mean and standard deviation. For the normally
distributed continuous variables median and interquartile range will be used. Categorical
variables will be reported using number and percentages.
Speremen rank or tau correlation coefficient will be performed to assess the correlation
between fetal cardiotacogram and conventional cardiotocography.
ANOVA will be used to compare the characteristics of the fetal outcome between the three
groups of conventional cardiotocography.
Independent t-test /Mann Whitney U test will be used to compare the fetal cardiotacogram
levels between fetal acidemia present and absent groups.
Logistic regression will be performed to predict the factors associated with neonatal
hypoxemia adjusted by other variables.
p value <5% is considered as statistically significant.
All the analysis will be carried out using SPSS software.
Duration of study: from October 2013 upto a minimum sample size of 79 is obtained.
7.2 INCLUSION CRITERIA
All women in active labor(3-7cms cervical dilatation) who have a singleton cephalic
presentation and gestational age >34 weeks.
7.3 EXCLUSION CRITERIA:
multiple gestation
CPD
Malpresentation
Second stage labour
Acute fetal distress secondary to cord prolapse and abruption placenta
Category III /abnormal cardiotocogram will be immediately acted upon.
7.4 STUDY DESIGN: Analytical study- cross sectional type.
7.5 Protocol of the Procedure
5

Those women who are eligible for study will be identified and an written informed consent
will be obtained.
CTG signals will be recorded during routine foetal monitoring. Subjects will be resting in
lying down position. In line with clinical practice, US-CTG signals lasting less than 20 min
or excessively noisy signals were excluded from the database.
The NICHD (Eunice Kennedy Shirver Institute of Child Health and Human
Development) workgroup proposed terminology of a three-tiered system
to replace the older undefined terms "reassuring" and "nonreassuring".

Category I (Normal): Tracings with all these findings present are

strongly predictive of normal fetal acid-base status at the time of
observation and the fetus can be followed in a standard manner:
o Baseline rate 110-160 bpm,
o

Moderate variability,

Absence of late, or variable decelerations,

Early decelerations and accelerations may or may not be

present.

Category II (Indeterminate): Tracing is not predictive of abnormal

fetal acid-base status, but evaluation and continued surveillance
and reevaluations are indicated.
o

Bradycardia with normal baseline variability

Tachycardia

Minimal or Marked baseline variability of FHR

Accelerations: Absence of induced accelerations after fetal

stimulation

Periodic or Episodic decelerations: Longer than 2min but

shorter than 10min; Recurrent late decelerations with
moderate baseline variability

Variable decelerations with other characteristics such as slow

return to baseline, overshoots of "shoulders" seen (humps on
either side of deceleration)

Category III (Abnormal): Tracing is predictive of abnormal fetal

acid-base status at the time of observation; this requires prompt
active management:
o

Absence of baseline variability with persistent recurrent late

or variable decelerations or bradycardia; or

Sinusoidal fetal heart rate.

The abnormal tracing if obtained will be acted upon immediately and shall be excluded from
doing the digitalised fetal cardiotacogram.
Then digitalised fetal cardiotacogram (power spectral analysis) using maternal
electrocardiogram done on maternal abdomen is obtained and undergoes adaptive filtering
will be used to extract fetal ECG inputs. Spectral analysis will be obtained using a Fast
Fourier Transform. The spectra obtained for the different data sets will be averaged to reduce
variance and to sharpen the reproducible central peaks. Power will be calculated in two
bands- low frequency and high frequency. And the total power will also be obtained. In
addition to this high and low frequency will be normalised to total power.Mode of delivery
will be recorded as either vaginal delivery/ LSCS/operative vaginal delivery.
Cord blood will be collected soon after clamping and cutting of cord and will be collected in
a preheparinised syringe and will be sent for blood gas analysis. It will be recorded as
Neonatal academia when the umbilical artery pH is less than 7.10
Primary outcome: Neonatal acidemia
Neonatal outcome will be measured as:
APGAR score at 1 and 5 minute
NICU admission
Number of birth asphyxia
APGAR SCORES at 1 and 5 minute
NICU admissions
Birth asphyxia
LSCS in view of fetal distress
Operative vaginal deliveries
7.6 Does the study require any investigations or interventions to be conducted on
patients or other human or animals? If so please describe briefly
CTG and maternal electrocardiogram
7.7 Has ethical clearance obtained from your institution in case of 7.3?
Ethical clearance has been obtained

References
1) Hutter. causes and mechanisms of intrauterine hypoxia and its impact on the
fetal cardiovascular system. International journal of pediatrics. 2010; 40: p. 1323.
2) Chauhan. intrapartum nonreassuring fetal heart rate tracing and prediction of
adverse outcome :interobserver variability. American journal of obstetrics and
gynecology. 2008; 199(6): p. 623 e1-e5.

3) Thaker. continious electronic heart rate monitoring for fetal assessment during
labour. the cochrane library. ; 4.
4) Sabir. perinatal hemorrhagic shock after fetal scalp blood sampling. obstetrics
and gynecology. 2010; 115(2): p. 419-20.
5)Pulgar .mild chronic hypoxemia modifies expression of brain stem angiotensin
peptide receptors and reflex response in fetal sheep. american journal of
physiology. 2009; 297(2): p. 446-52
6) Frasch. heart rate variability analysis allows early asphyxia detection in ovine
fetus. reproductive science. 2009; 16(5): p. 509-17.

7)Siimes. regulation of heart rate variation by autonomic nervous system in

neonatal lambs. pediatrics res. 1990; 27(4): p. 383-91.
8) souza D. fetal distress and birth scores in newborn infants. Manchester: university of Manchester,
department of child health.
9) Low JA. determining the contribution of asphyxia to brain damage in neonate. journal of obstetrics
and gynecology. 2004 aug; 30(4): p. 276- 86.
10) Larma JD. Intrapartum electronic fetal heart rate monitoring and the identification of metabolic
acidosis and hypoxic-ischemic encephalopathy. american journal of obstetrics and gynecology.
2007 september; 197(3): p. 301 e1.
11) Low JA. Predictive value of electronic fetal monitoring for intrapartum fetal asphyxia with
metabolic acidosis. journal of obstetrics and gynecology. 1999 feb; 93(2): p. 285- 91.
12) Niger. Medical journal. 2012 sep; 53(3 pg 145-149).
13) Dellinger EH. electronic fetal heart rate monitoring: early neonatal outcomes associated with
normal rate , fetal stress and fetal distress. american journal of obstetrics and gynecology. 2000
jan; 182(1).
14) Siiara. marked fetal acidosis and specific changes in power spectrum analysis of fetal heart rate
variability recorded during the last hour of labor. british journal of obstetrics and gynecology. 2005
; 112: p. 418- 23.
15) Siiara S. intrapartum hypoxia and power spectral analysis of fetal heart rate variability. university
of turku, department of obstetrics and gynecology.

11 Signature of the candidate :

11.1 Name and designation Dr. Sheela CN

8

HOD & Professor

Department of Obstetrics and Gynecology
St.Johns Medical college.

11.2 Signature:

11.3 Head of the Department: Dr. Sheela CN

HOD & Professor
Department of Obstetrics and Gynecology
St.Johns Medical college
11.4 Signature

12.1 Remarks of the chairman & Principal:

12.2 Signature

A comparative study to evaluate the predictability of perinatal outcome by digitalised fetal

cardiotacogram (including power spectral analysis) with conventional cardiotocography.
PROFORMA
Subject name:
Subject code:
Age:
OP no/ IPno:
Occupation:
Address:

LMP:

EDD:

Parity index: G P L A D E

gestational age:

Obstetric complication:

Medical complication:

Inclusion criteria
nulliparous/multiparous

nulli/multi

singleton pregnancy

yes/no
10

cephalic presentation

yes/no

>34 weeks

yes/no

in active labour

yes/no (

cms dilatation)

EXCLUSION CRITERIA:
multiple gestation

yes/no

CPD

yes/no

Malpresentation

yes/no

Second stage labour yes/no

Acute fetal distress

yes/no

Maternal examination:
Height:

weight:

Pulse rate:

BP:

temperature:

Comments:

Fetal assessment:
CTG :
Duration of the recording:

timing of recording:

FHR
VARIABILITY
ACCELERATION
DECCELERATION

CATEGORY- I/II/III
Comments:

11

Digitalised fetal cardiotacogram:

Duration of recording:

timing of recording:

Comments:

Details of delivery:

time of birth:

Gestational age

Term

Preterm

Vaginal delivery

Yes

No

Operative vaginal delivery

Yes

No

LSCS for fetal distress

Yes

No

LSCS for other indication

Yes

No

Umbilical cord pH

Acidic

Normal/basic

APGAR

At 1 minute-

At 5 minute-

NICU admission

Yes

No

Birth asphyxia

Yes

No

Comments:
Neonatal outcome:

Comments:

12

Consent form

Study titled

A comparative study to evaluate the predictability of perinatal

outcome by digitalized fetal cardiotacogram (including power spectral analysis)

with conventional cardiotocography.

Subjects Statement
I voluntarily accept to participate in the study titled A comparative study to
evaluate the predictability of perinatal outcome by digitalized fetal
cardiotacogram (including power spectral analysis) with conventional
cardiotocography.
The nature, demands and hazards involved in these studies have been
fully explained to me. I understand that I may withdraw from these studies at
any time for any reason and that I will not have to pay for the procedure.

confirm that I have passed my eighteenth birthday, the required minimum age
necessary to take part in an adult research study and to provide independent
consent.
I consent to the release of scientific data resulting from my participation in
this study to the Principal Investigator for use by him/her for scientific purposes.
The Principal Investigator assures my anonymity. I understand that the record of
this experiment becomes part of SJRI medical record and is protected as a
confidential document.

I understand that this record will only be available to

physicians and investigators involved with this study. Other SJRI staff may be
authorized by the SJRI Head to review the record for administrative purposes or
for monitoring the quality of patient care.
In the unlikely event of physical injury resulting from participation in this
research, I understand that medical treatment will be available from the SJMC
13

hospital, including first aid, emergency treatment and follow-up care as needed.
However, no compensation can be provided for medical care apart from the
foregoing.

I also understand that by my participation in this study I am not

waiving any of my legal rights. I understand that in the case of any problem I
can contact Dr Rema Devi, convener, Institutional Ethical Review Board, St Johns
Medical College.

Date:

---------------------------------

Signature:

---------------------------

Witness: --------------------------------

Name:

---------------------------

Physicians Statement:

I have carefully explained the nature, demands and foreseeable risks of the
above studies to the patient.

Date: ------------------------------------

Signature:

------------------------------

14