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Evidence reviews for initial assessment of women reporting prelabour rupture of membranes
Evidence review B
NICE Guideline, No. 235
Initial assessment after prelabour rupture of membranes
Review question
What is the optimum timeframe between a mother reporting possible prelabour rupture of the membranes and face-to-face clinical review?
Introduction
Pre-labour rupture of membranes (PRoM) occurs in 8% of pregnancies and around 60% of these women will begin labour spontaneously within 24 hours. There are serious, but uncommon risks associated with PRoM, such as cord prolapse, cord compression, placental abruption and neonatal infection. It is therefore important that women with suspected PRoM are assessed by a maternity care professional, but there is variation in practice and no current guidance about the nature or timing of this review.
The aim of this review is to determine how soon after the membranes have ruptured an in-person clinical review of the woman should be carried out.
Summary of the protocol
See Table 1 for a summary of the Population, Intervention, Comparison and Outcome (PICO) characteristics of this review.
For further details see the review protocol in appendix A.
Methods and process
This evidence review was developed using the methods and process described in Developing NICE guidelines: the manual. Methods specific to this review question are described in the review protocol in appendix A and the methods document (supplementary document 1).
Declarations of interest were recorded according to NICE’s conflicts of interest policy.
The committee agreed that only studies conducted in high-income countries (as defined by the Organisation for Economic Co-operation and Development [OECD]) should be considered for inclusion because clinical monitoring following suspected rupture of membranes is likely to vary between high and low/middle income countries.
The protocol makes reference to ‘face-to-face clinical review’, whereas the recommendations and discussion of the evidence use the terminology ‘in-person (clinical review)’. The committee preferred the latter wording as the former could be taken to mean a video call.
Effectiveness
Included studies
A systematic review of the literature was conducted but no studies were identified which were applicable to this review question.
See the literature search strategy in appendix B and study selection flow chart in appendix C.
Excluded studies
Studies not included in this review are listed, and reasons for their exclusion are provided in appendix J.
Summary of included studies
No studies were identified which were applicable to this review question (and so there are no evidence tables in Appendix D). No meta-analysis was conducted for this review (and so there are no forest plots in Appendix E).
Summary of the evidence
No studies were identified which were applicable to this review question (and so there are no GRADE tables in Appendix F).
Economic evidence
Included studies
A systematic review of the economic literature was conducted but no economic studies were identified which were applicable to this review question.
Economic model
No economic modelling was undertaken for this review because the committee agreed that other topics were higher priorities for economic evaluation.
The committee’s discussion and interpretation of the evidence
The outcomes that matter most
The committee chose maternal admission to intensive therapy unit (ITU) or high-dependency area, mode of birth and requirement for antibiotics as the critical outcomes for this review. As both maternal admission and requirement for antibiotics are common negative outcomes for women associated with PRoM, the committee agreed that these were the best indicators to understand the differential effectiveness of different timeframes between a woman reporting possible PRoM and an in-person clinical review. The committee also wanted to find out whether different timeframes would impact the mode of birth and agreed that this was a meaningful outcome for making recommendations, both in terms of the woman and the health system.
The committee also agreed on the important outcomes for this review. As induction of labour is recommended 24 hours after PRoM due to an increased risk of infection, the committee wanted to include induction of labour and evidence of maternal infection as important outcomes as these are likely to be impacted by different timeframes between a woman reporting PRoM and an in-person face-to-face clinical review. They also agreed that it was also important to find out about women’s experience of labour and birth. The committee recognised the great importance of women’s experience of labour and birth in the presence of suspected PRoM, but they were aware that data on this outcome was likely to be sparse and unlikely to inform decision-making in a meaningful way, so they prioritised other outcomes as critical.
Finally, the committee chose neonatal admission as an important outcome as this would indicate whether there are any risks for the baby associated with different timeframes between a woman reporting PRoM and a face-to-face clinical review.
The quality of the evidence
No evidence was identified which was applicable to this review question.
Benefits and harms
The committee noted that the protocol had included women with preterm PRoM (less than 37 weeks) but that the NICE guidelines on Preterm labour and birth already included recommendations on the management of preterm PRoM and so they restricted their discussions and recommendations to women with PRoM at term (37 to 42 weeks) which is aligned with the scope of the Intrapartum care guidance.
No evidence was identified for the timeframe between a woman reporting possible PRoM and an in-person clinical assessment, so the committee based the recommendations on their experience and expertise. The committee agreed that while the recommendations would reflect current practice in many Trusts, the recommendations would help to reduce variation in practice and reliance on women’s knowledge and perception of risk.
The committee discussed the triage of women reporting possible PRoM and agreed that in practice, the urgency of an in-person clinical assessment should be based on the presence of risk factors. The committee agreed that a list of risk factors would be useful in determining the urgency of an in-person clinical assessment and decided that a woman should be seen immediately if any one of these factors is present. The committee noted that some of these factors would require women to be offered immediate induction, for example, if she has a positive group B streptococcus test, and that recommendations relating to the timing of induction were already present in the NICE guideline on Inducing labour and the NICE guideline on Neonatal infection. The committee therefore included these recommendations in the guideline and cross-referenced to these other relevant NICE guidelines.
The committee agreed that women who do not have any risk factors should be seen within 12 hours or as soon as possible if the woman has any concerns or wishes to be induced immediately. The committee discussed the timeframe and agreed that there was no clinical reason there should be a delay in an in-person clinical assessment, but they agreed that for this lower risk group, the benefits of urgency should be balanced with the preferences of the woman, for example wanting to spend the night at home or taking time to arrange childcare and agreed that within 12 hours would be a reasonable pragmatic time to allow this. The committee agreed that the in-person assessment of a woman without risk factors could be carried out at the woman’s intended place of birth, be that at home, in a midwifery-led unit or an obstetric unit. The committee noted that the deployment of community midwives may be needed in cases where the woman was unable to reach the maternity unit within 12 hours, however, they decided not to make a recommendation on this as this would be determined at the local level.
The committee discussed whether to make a research recommendation as no evidence had been identified but agreed that as a risk assessment was necessary for women presenting with PRoM (as they had advised in their recommendations), and as this was an area where maternal preference and planned place of birth also had a large impact on the decision, a study randomising women to different times for assessment would be unlikely to be conducted.
Cost effectiveness and resource use
The committee agreed that the recommendation for women with risk factors is in line with current practice. However, the recommendation for women without risk factors may result in more women being seen in-person within a shorter timeframe than current practice, as some units currently advise longer delays than this. The committee agreed that this is unlikely to have a significant impact on resources as it is only bringing the time of review for some women earlier by a few hours. However, although no clinical evidence was identified, the committee made a qualitative assessment that the recommendations based on their expertise and experience would represent a cost-effective use of NHS resources.
Recommendations supported by this evidence review
This evidence review supports recommendations 1.7.1, 1.7.2, 1.7.6, 1.7.7 and 1.7.11.
References – included studies
Effectiveness
No evidence was identified which was applicable to this review question.
Appendices
Appendix A. Review protocols
Appendix B. Literature search strategies
Appendix C. Effectiveness evidence study selection
Appendix D. Evidence tables
Evidence tables for review question: What is the optimum timeframe between a mother reporting possible PRoM and face-toface clinical review?
No evidence was identified which was applicable to this review question.
Appendix E. Forest plots
Forest plots for review question: What is the optimum timeframe between a mother reporting possible PRoM and face-to-face clinical review?
No meta-analysis was conducted for this review question and so there are no forest plots.
Appendix F. GRADE tables
GRADE tables for review question: What is the optimum timeframe between a mother reporting possible PRoM and face-toface clinical review?
No evidence was identified which was applicable to this review question.
Appendix G. Economic evidence study selection
Appendix H. Economic evidence tables
Economic evidence tables for review question: What is the optimum timeframe
Appendix I. Economic model
Economic model for review question: What is the optimum timeframe between a mother reporting possible PRoM and face-to-face clinical review?
No economic analysis was conducted for this review question.
Appendix J. Excluded studies
Excluded studies for review question: What is the optimum timeframe between a mother reporting possible PRoM and face-to-face clinical review?
Excluded effectiveness
Table 3Excluded studies and reasons for their exclusion
| Study | Reason for exclusion |
|---|---|
| Carlan, S. J., O’Brien, W. F., Parsons, M. T. et al. (1993) Preterm premature rupture of membranes: a randomized study of home versus hospital management. Obstetrics and gynecology 81(1): 61–4 [PubMed: 8416463] |
- Intervention not in PICO Study compares latency periods of women diagnosed with PRoM randomised to home or hospital management. Study does not report timeframe from presentation/ reporting of possible PRoM to clinical assessment/ review |
| Chacon, Kelly M.; Bryant Mantha, Allison S.; Clapp, Mark A. (2021) Outpatient Expectant Management of Term Prelabor Rupture of Membranes: A Retrospective Cohort Study. American journal of perinatology 38(7): 714–720 [PubMed: 31891951] |
- Intervention not in PICO Study compares latency periods of women diagnosed with PRoM randomised to home or hospital management. Study does not report timeframe from presentation/ reporting of possible PROM to clinical assessment/ review |
| Munson, L. A., Graham, A., Koos, B. J. et al. (1985) Is there a need for digital examination in patients with spontaneous rupture of the membranes?. American journal of obstetrics and gynecology 153(5): 562–3 [PubMed: 4061518] |
- Intervention not in PICO Study compares two methods of membrane examination. Study does not report timeframe from presentation/ reporting of possible PRoM to clinical assessment/ review |
| Papadakis, K. and Pande, B. (2017) The role of Actim PROM in the clinical diagnosis of PPROM. BJOG: An International Journal of Obstetrics and Gynaecology 124(supplement1): 138–139 | - Conference abstract |
| Singhal, Seema; Puri, Manju; Gami, Neha (2012) An analysis of factors affecting the duration of latency period and its impact on neonatal outcome in patients with pprom. International Journal of Infertility and Fetal Medicine 3(3): 87–91 |
- Intervention not in PICO Prospective cohort study reporting factors associated with length of latency period in women with PPRoM. Study does not report timeframe from presentation/ reporting of possible PRoM to clinical assessment/ review |
| Warwar, Rachel E., Kuss, Brittany N., Elliott, John O. et al. (2019) Financial Analysis of Expectant Management of Preterm Premature Rupture of Membranes to Term in a Community Hospital. Obstetrics and Gynecology 133(suppl1) | - Conference abstract |
Excluded economic studies
No economic evidence was identified for this review.
Appendix K. Research recommendations – full details
Research recommendations for review question: What is the optimum timeframe between a mother reporting possible PRoM and face-to-face clinical review?
No research recommendations were made for this review question.
Tables
Table 1Summary of the protocol (PICO table)
| Population |
|
|---|---|
| Intervention | Face-to-face clinical review advised as soon as possible (< 3 hours) after a mother telephoning to report PRoM |
| Comparison | Face-to-face clinical review delayed between the timeframes stated below after a mother telephoning to report PRoM
|
| Outcome |
Critical
Important
|
ITU: intensive therapy unit; NICU: neonatal intensive care unit; PRoM: pre-labour rupture of membranes; SCBU: special care baby unit
Final
Evidence reviews underpinning recommendations 1.7.1, 1.7.2, 1.7.6, 1.7.7 and 1.7.11 in the NICE guideline
This evidence review was developed by NICE
Disclaimer: The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or service users. The recommendations in this guideline are not mandatory and the guideline does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.
Local commissioners and/or providers have a responsibility to enable the guideline to be applied when individual health professionals and their patients or service users wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with compliance with those duties.
NICE guidelines cover health and care in England. Decisions on how they apply in other UK countries are made by ministers in the Welsh Government, Scottish Government, and Northern Ireland Executive. All NICE guidance is subject to regular review and may be updated or withdrawn.