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LGH Policy 2.

27/09WACS Title: Replaces: Description: Target Audience: Key Words: Policy Supported: Tocolysis for Threatened Preterm Labour Tocolysis for Threatened Preterm Labour WACSClinProc2.7/06WACS Administration of tocolytic agents to delay birth Midwifery and Medical Staff, Queen Victoria Maternity Unit Threatened preterm labour, tocolysis, nifedipine, salbutamol P2010/0498-001 Preterm Labour P2010/0507-001 Preterm Prelabour Rupture of Membranes

Purpose: The aim of tocolysis is to delay preterm birth to allow time for the administration of corticosteroids and/or in-utero transfer to a tertiary perinatal centre. Preterm birth is a major cause of perinatal morbidity and mortality. Tocolytic agents are effective in reducing the likelihood of birth within 48 hours, but do not reduce the overall risk of preterm birth. Indications for Tocolysis Consideration should be given for the administration of tocolytics to all women experiencing preterm labour when there is a need to delay birth: to permit in-utero transfer to a tertiary perinatal centre to gain up to 48 hours to allow for the administration of corticosteroids to enhance pulmonary maturity. Tocolytic Agents Unless contra-indicated, the first line tocolytic to be used should be nifedipine. Nifedipine is a calcium channel blocker that inhibits both prostaglandin and oxytocin induced contractions. It has similar tocolytic activity to Salbutamol but a lower incidence of maternal side effects. Salbutamol may be used a second line tocolytic agent in the absence of contraindications. It must not be used in addition to Nifedipine as the two drugs have potentially synergistic actions. Contraindications and Side Effects of Tocolytics Prior to the administration of tocolytics the mother should be informed of the need for tocolytics as well as the benefits and possible maternal and fetal side effects of the agent to be used. Nifedipine Maternal Contraindications Hypotension (systolic BP less than 90mmHg) Previous adverse reaction to calcium channel blockers Cardiac disease (congestive cardiac failure, aortic stenosis) Hepatic dysfunction Pre-eclampsia
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Fetal contraindications Suspected intrauterine infection Labour in the presence of placenta praevia Placenta abruptio/undiagnosed significant vaginal bleeding Severe fetal growth restriction Lethal fetal abnormalities Fetal death in utero Common Side Effects Palpitations, peripheral oedema, hypotension, dizziness, flushing, headache, nausea, vomiting Rare Side Effects Abnormal liver function tests, congestive cardiac failure, transient hyperglycaemia, tachycardia, chest pain, ischaemia (retinal, cerebral) tinnitus, pruritus Administration Initial dose 20mg Nifedipine crushed to aid digestion. If uterine contractions persist after 30 minutes administer another 20mg Nifedipine crushed. This can be repeated at 30 minutes intervals for a further two doses (total 80mg) Maximum dose in 24 hours is 160 mg. If contractions cease commence maintenance dose of 20 to 40mg six hourly with a maximum dose of 160 mg in 24 hours. Maternal and Fetal Observations Maternal blood pressure, temperature, pulse and respiratory rate hourly initially. Once stabilised, observations should be recorded fourth hourly. Report systolic BP less than 100mmHg, temperature greater than 37.5C or pulse greater than 100. Report any of the side effects listed above. If initial cardiotocograph is reactive, record fetal heart rate hourly with Doppler during the acute stabilisation phase then at least 6 hourly during for the first 48 hours. Salbutamol Maternal Contraindications Cardiac disease Hyperthyroidism Uncontrolled diabetes mellitus Fetal contraindications Placenta abruptio or significant uterine bleeding of unknown cause Fetal death or major fetal abnormality Chorioamnionitis Maternal Side Effects Beta-sympathomimetics are not utero-specific and have significant cardiovascular and other side effects (chest pain, cardiac arrhythmias, palpitations, tachycardia, hypotension, tremor, dizziness, headache, dyspnoea, nausea and vomiting). Several maternal deaths have been reported, which have been associated with either pre-existing cardiac disease or pulmonary oedema after excessive use of intravenous fluids.
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Administration Remove 10ml normal saline from 100ml bag and discard. Add 10mg (10ml) Salbutamol to remaining 90ml of normal saline. Using an infusion pump commence infusion at 12ml per hour. Increase rate by 6ml per hour every 30 minutes until there is a suitable response, either cessation of contractions or a reduction in the frequency and strength of contractions. Do not exceed 36ml/hr. Maternal and Fetal Observations Maternal blood pressure, pulse and respiratory rate following each increase in the infusion rate during the acute stabilisation phase. Observations may then be recorded less frequently, but at least four hourly during treatment. If initial cardiotocograph is reactive, record fetal heart rate with Doppler after each increase in the infusion rate during the acute stabilisation, then at least 6 hourly for first 48 hours. If maternal pulse greater than 140 bpm or sustained fetal tachycardia (greater than 180bpm) reduce infusion rate until pulse or fetal heart rate return below these levels. Cease the infusion if the woman complains of chest pain, dyspnoea or vomiting. Attachments
Attachment 1 Attachment 2 Attachment 3 Nifedipine Administration Protocol Salbutamol Infusion Protocol References

Performance Indicators: Evaluation of compliance with guideline to be achieved through medical record audit annually by clinical Quality improvement Midwife WACS Review Date: Annually verified for currency or as changes occur, and reviewed every 3 years. Midwives and medical staff WACS Dr A Dennis Co-Director (Medical) Sue McBeath Co-Director (Nursing & Midwifery) Womens & Childrens Services

Stakeholders: Developed by:

Dr A Dennis Co-Director (Medical) Womens & Childrens Services

Sue McBeath Co-Director (Nursing & Midwifery) Womens & Childrens Services

Date: _________________________

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APPENDIX 1 Nifedipine Administration Protocol Note: Nifedipine is classified as a risk category c drug in pregnancy. It carries the potential for fetal hypoxia associated with maternal hypotension. The blood pressure lowering effect of Nifedipine may be potentiated by other antihypertensive drugs. PRESENTATION 20mg tablets ADMINISTRATION Nifedipine tablets should be crushed to aid absorption in pregnancy. Dose may vary with clinical situation & should be titrated against tocolytic effect. Nifedipine is highly light sensitive. Broken tablets should not be used. INITIAL DOSE 20 mg Nifedipine (crushed) orally stat MAXIMUM DOSE 160mg in 24 hours If uterine A further 20mg Nifedipine (crushed) orally may be contractions given at 30 minute intervals for two further doses. persist after 30 minutes: If contractions A maintenance dose of 20 to 40mg Nifedipine 6 hourly cease may be given, depending on uterine activity and other clinical circumstances, to a maximum of 160mg in 24 hours. Decision about cessation of treatment will be on an individual basis and need to take into account location, steroid cover and gestational age. MATERNAL and Maternal blood pressure, temperature, pulse and FETAL respiratory rate hourly during the acute stabilisation OBSERVATIONS phase. Observations may then be recorded less AND frequently but at least 4 hourly during treatment. MONITORING Report systolic BP less than 100mmHg, temperature greater than 37.5 C or pulse greater than 100. Report side effects listed above. If initial cardiotocograph is reactive, record fetal heart rate hourly with doppler during the acute stabilisation phase, then at least 6 hourly for the first 48 hours. Overdosage Disturbed consciousness to the point of coma Symptoms A drop in blood pressure (observed in Tachycardic/bradycardic heart rhythm disturbances cases of severe Hyperglycaemia nifedipine Hypoxia intoxication) Cardiogenic shock with pulmonary oedema

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APPENDIX 2 Salbutamol Infusion Regime Note: To prevent hypotension due to aorto-caval compression, the woman should lie on her side during the infusions. PRESENTATION Ventolin Obstetric 5mg ampoules (1mg per ml) ADMINISTRATION Salbutamol should be given by infusion pump to control dose and fluid volume. Caution is required when changing to salbutamol form a vasodilator such as nifedipine, which has a half-life of 6 to 12 hours. In these circumstances, frequent maternal and fetal observations are required. DOSE Draw up 10ml (10mg) of obstetric salbutamol in a 10 ml syringe Withdraw 10ml from a 100ml bag of normal saline and replace with the 10ml salbutamol. The resulting solution will contain 100 micrograms per ml Start the infusion at 12ml per hour Increase the rate by 6 ml every 30 minutes until there is a suitable response, either cessation of contractions or a reduction in the frequency and strength of contractions Do not exceed 36ml/hr If maternal pulse Slow infusion rate until pulse or fetal heart rate return greater than 140 below these levels bpm or sustained fetal tachycardia (greater than 180 bpm) Side effects Tremor, anxiety, nausea and palpitations are likely and the woman should be warned CEASE INFUSION if chest pain, dyspnoea or vomiting occurs If contractions Maintain infusion rate for the next 4 hours and then cease reduce by 6ml/hr every 4 hours until 12ml/hr. Decisions about cessation of treatment are to be made on an individual basis. MATERNAL and Maternal blood pressure, pulse and respiratory rate FETAL following each increase in infusion rate following each OBSERVATION increase in the infusion rate during the acute AND stabilisation phase. Observations may then be MONITORING recorded less frequently, but at least 4 hourly during treatment; If initial cardiotocograph is reactive, record fetal heart rate with Doppler after each increase in the infusion rate during the acute stabilisation phase, then at least 6 hourly for the first 48 hours.

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APPENDIX 3 Choice of Tocolytic agents Beta-sympathomimetics - Salbutamol These are the most widely used tocolytic and have been extensively studied in randomised controlled trials. Salbutamol has been the most widely used betasympathomimetic in Australia and was recommended by the NHMRC in it 1996 report. It must be given intravenously; it has several maternal contraindications and significant maternal side effects. Calcium antagonists nifedipine Nifedipine is an equally effective tocolytic, as shown by a recent Cochrane Review. It is administered orally and has fewer maternal side effects. However, nifedipine is not approved for use in pregnancy and is classified as a risk Category C drug by the Australian Evaluation Committee. Oxytocin antagonists atosiban Atosiban appears to be as effective as beta-mimetics. It has fewer side effects but is much more expensive than other options in preterm labour. However, it is not approved for used in Australia. Prostaglandin antagonists - indomethacin Indomethacin has been compared in small trials with beta-mimetics. These have suggested equal efficacy in delaying preterm birth but there are concerns about adverse affects on the fetal circulation. Other agents glyceryl trinitrate Glyceryl trinitrate patches have been evaluated in a small number of women and there is insufficient evidence to support use in routine clinical practice. Magnesium Sulphate Magnesium sulphate is used for tocolysis in the USA. Magnesium sulphate was found to be ineffective at delaying birth or preventing preterm birth, and its use is associated with an increased mortality for the infant.

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APPENDIX 4 REFERENCES Crowther CA, Hiller JE, Doyle LW. Magnesium sulphate for preventing preterm birth in threatened preterm labour (Cochrane Review). The Cochrane Database of Systematic Reviews 2002, Issue 4. Art. No.: CD001060. DOI:10.1002/14651858.CD001060. Ingemarsson I. Lamont R. An update on the controversies of tocolytic therapy for the prevention of preterm birth. Acta Obstetricia et Gyncologica Scandinavica 2003: 82:1-9. Lamont R and the International Preterm Labour Council. Evidence-based labour ward guidelines for the diagnosis, management and treatment of spontaneous preterm labour. Journal of Obstetrics and Gynaecology 2003: 5:460-478. New South Wales Department of Health Policy Directive 2005 Tocolytic agents Protocols for administration for threatened preterm labour. Online: http://www.health.nsw.gov.au/policies/PD/2005/PD2005_249.html Royal College of Obstetricians and Gynaecologists Clinical Guideline No.1(B) 2002 Tocolytic drugs for women in preterm labour. Online: http://www.rcog.org.uk/womenshealth/clinical-guidance/tocolytic-drugs-women-preterm-labour-green-top-1b

Attachments
Attachment 1

Performance Indicators: Evaluation of compliance with guideline to be achieved through medical record audit Review Date: Annually verified for currency or as changes occur, and reviewed every 3 years Midwives and medical staff WACS Dr A Dennis Co-Director (Medical) Sue McBeath Co-Director (Nursing & Midwifery) Womens & Childrens Services

Stakeholders: Developed by:

Dr A Dennis Co-Director (Medical) Womens & Childrens Services

Sue McBeath Co-Director (Nursing & Midwifery) Womens & Childrens Services

Date: December 2009


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