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Preterm Labour and Birth

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Preterm Labour and Birth DRAFT FOR CONSULTATION 1 2 Preterm labour and birth 3 4 5 NICE guideline: short version 6 Draft for consultation, June 2015 7 If you wish to comment on this version of the guideline, please be aware that all the supporting information and evidence is contained in the full version. 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 Preterm labour and birth: NICE guideline DRAFT (May 2015) Page 1 of 38 DRAFT FOR CONSULTATION 1 Contents 2 Introduction ...................................................................................................... 3 3 Patient-centred care ......................................................................................... 5 4 Strength of recommendations .......................................................................... 6 5 1 Recommendations .................................................................................... 8 6 Terms used in this guideline ......................................................................... 8 7 1.1 Information and support ...................................................................... 9 8 1.2 Prophylactic vaginal progesterone and prophylactic cervical cerclage 9 10 10 1.3 Diagnosing preterm prelabour rupture of membranes (P-PROM) ..... 11 11 1.4 Antenatal prophylactic antibiotics for women with P-PROM ............. 12 12 1.5 Identifying infection in women with P-PROM .................................... 12 13 1.6 'Rescue’ cervical cerclage ................................................................ 13 14 1.7 Diagnosing preterm labour for women with intact membranes ......... 13 15 1.8 Maternal corticosteroids .................................................................... 16 16 1.9 Magnesium sulfate for neuroprotection ............................................. 16 17 1.10 Tocolysis........................................................................................ 17 18 1.11 Fetal monitoring ............................................................................. 18 19 1.12 Mode of birth .................................................................................. 20 20 1.13 Timing of cord clamping for preterm babies (born vaginally or by 21 caesarean section) ..................................................................................... 21 22 2 Implementation: getting started ............................................................... 22 23 3 Research recommendations .................................................................... 22 24 4 Other information ..................................................................................... 25 25 5 The Guideline Committee, National Collaborating Centre and NICE 26 project team, and declarations of interests .................................................... 28 27 Preterm labour and birth: NICE guideline DRAFT (June 2015) Page 2 of 38 DRAFT FOR CONSULTATION 1 Introduction 2 Preterm birth is the single biggest cause of neonatal mortality and morbidity in 3 the UK. Over 52,000 babies (around 7.3% of live births) in England and Wales 4 in 2012 were born preterm – that is, before 37+0 weeks of pregnancy. There 5 has been no decline in the preterm birth rate in the UK over the last 10 years. 6 Babies born preterm have high rates of early, late and postneonatal mortality, 7 and the risk of mortality increases as gestational age at birth decreases. 8 Babies who survive have increased rates of disability. Recent UK studies 9 comparing cohorts born in 1995 and 2006 have shown improved rates of 10 survival (from 40% to 53%) for extreme preterm births (born between 22 and 11 26 weeks). Rates of disability among survivors were largely unchanged over 12 this time period. 13 The major long-term consequence of prematurity is neurodevelopmental 14 disability. Although the risk for the individual child is greatest for those born at 15 the earliest gestational ages, the global burden of neurodevelopmental 16 disabilities depends on the number of babies born at each of these gestations, 17 and so is greatest for babies born between 32 and 36 weeks, less for those 18 born between 28 and 31 weeks, and least for those born at less than 19 28 weeks gestation. 20 Around 75% of women delivering preterm do so after preterm labour, which 21 may or may not be preceded by preterm prelabour rupture of membranes. 22 The remaining women delivering preterm have an elective preterm birth when 23 this is thought to be in the fetal or maternal interest (for example, because of 24 extreme growth retardation in the baby or maternal conditions such as pre- 25 eclampsia). 26 This guideline reviews the evidence for the best way to provide treatment for 27 women who present with symptoms and signs of preterm labour and women 28 who are scheduled to have a preterm birth. It also reviews how preterm birth 29 can be optimally diagnosed in symptomatic women, given that many women 30 thought to be in preterm labour on a clinical assessment will not deliver 31 preterm. Preterm labour and birth: NICE guideline DRAFT (June 2015) Page 3 of 38 DRAFT FOR CONSULTATION 1 The guideline does not cover who should and should not have medically 2 indicated preterm birth, or diagnostic or predictive tests in asymptomatic 3 women. 4 Medicines 5 The guideline will assume that prescribers will use a medicine’s summary of 6 product characteristics to inform decisions made with individual patients. 7 This guideline recommends some medicines for indications for which they do 8 not have a UK marketing authorisation at the date of publication, if there is 9 good evidence to support that use. The prescriber should follow relevant 10 professional guidance, taking full responsibility for the decision. The patient 11 (or those with authority to give consent on their behalf) should provide 12 informed consent, which should be documented. See the General Medical 13 Council’s Prescribing guidance: prescribing unlicensed medicines for further 14 information. Where recommendations have been made for the use of 15 medicines outside their licensed indications (‘off-label use’), these medicines 16 are marked with a footnote in the recommendations. 17 Preterm labour and birth: NICE guideline DRAFT (June 2015) Page 4 of 38 DRAFT FOR CONSULTATION 1 Patient-centred care 2 This guideline offers best practice advice on the care of women during 3 preterm labour and birth. 4 Patients and healthcare professionals have rights and responsibilities as set 5 out in the NHS Constitution for England – all NICE guidance is written to 6 reflect these. Treatment and care should take into account individual needs 7 and preferences. Patients should have the opportunity to make informed 8 decisions about their care and treatment, in partnership with their healthcare 9 professionals. If the patient is under 16, their family or carers should also be 10 given information and support to help the child or young person to make 11 decisions about their treatment. If it is clear that the child or young person fully 12 understands the treatment and does not want their family or carers to be 13 involved, they can give their own consent. Healthcare professionals should 14 follow the Department of Health’s advice on consent. If someone does not 15 have capacity to make decisions, healthcare professionals should follow the 16 code of practice that accompanies the Mental Capacity Act and the 17 supplementary code of practice on deprivation of liberty safeguards. 18 NICE has produced guidance on the components of good patient experience 19 in adult NHS services. All healthcare professionals should follow the 20 recommendations in Patient experience in adult NHS services.. 21 Preterm labour and birth: NICE guideline DRAFT (June 2015) Page 5 of 38 DRAFT FOR CONSULTATION 1 Strength of recommendations 2 Some recommendations can be made with more certainty than others. The 3 Guideline Committee makes a recommendation based on the trade-off 4 between the benefits and harms of an intervention, taking into account the 5 quality of the underpinning evidence. For some interventions, the Guideline 6 Committee is confident that, given the information it has looked at, most 7 patients would choose the intervention. The wording used in the 8 recommendations in this guideline denotes the certainty with which the 9 recommendation is made (the strength of the recommendation). 10 For all recommendations, NICE expects that there is discussion with the 11 patient about the risks and benefits of the interventions, and their values and 12 preferences. This discussion aims to help them to reach a fully informed 13 decision (see also ‘Patient-centred care’). 14 Interventions that must (or must not) be used 15 We usually use ‘must’ or ‘must not’ only if there is a legal duty to apply the 16 recommendation. Occasionally we use ‘must’ (or ‘must not’) if the 17 consequences of not following the recommendation could be extremely 18 serious or potentially life threatening. 19 Interventions that should (or should not) be used – a ‘strong’ 20 recommendation 21 We use ‘offer’ (and similar words such as ‘refer’ or ‘advise’) when we are 22 confident that, for the vast majority of patients, an intervention will do more 23 good than harm, and be cost effective. We use similar forms of words (for 24 example, ‘Do not offer…’) when we are confident that an intervention will not 25 be of benefit for most patients. 26 Interventions that could be used 27 We use ‘consider’ when we are confident that an intervention will do more 28 good than harm for most patients, and
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