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Intrauterine fetal death after previous caesarean birth
Evidence review D
NICE Guideline, No. 207
National Guideline Alliance (UK).
Methods to induce labour after intrauterine fetal death and previous caesarean birth
Review question
How should labour be induced in women with intrauterine fetal death who have had a previous caesarean birth?
Introduction
Intrauterine fetal death (IUFD) is defined as death of the fetus at or after the 24+0 weeks of pregnancy. The rate of IUFD is approximately 0.5% of all pregnancies.
Options for birth after diagnosis of IUFD are expectant management, immediate induction, delayed induction or caesarean birth. Birth should be expedited where there is evidence of maternal sepsis, severe pre-eclampsia, abruption, or when it is the mother’s choice.
Vaginal birth following induction may lead to quicker recovery, and avoids the risks associated with a caesarean birth. However, some women may choose to have a caesarean birth as they perceive it to be less psychologically distressing. In women who elect for vaginal birth, labour can be induced with mifepristone followed by vaginal dinoprostone or misoprostol, but consideration needs to be given to the fact that women with an IUFD who have had a previous caesarean birth may be at an increased risk of uterine rupture.
The aim of this review is to identify the most effective and safest way to induce labour in women with an IUFD who have had a previous caesarean birth.
Summary of the protocol
See Table 1 for a summary of the Population, Intervention, Comparison and Outcome (PICO) characteristics of this review.
Table 1
Summary of the protocol (PICO table).
Methods and process
This evidence review was developed using the methods and process described in Developing NICE guidelines. Please see the methods chapter for further details. Methods specific to this review question are described in the review protocol in appendix A.
Declarations of interest were recorded according to NICE’s 2014 conflicts of interest policy until 31 March 2018. From 1 April 2018, declarations of interest were recorded according to NICE’s 2018 conflicts of interest policy. Those interests declared until April 2018 were reclassified according to NICE’s 2018 conflicts of interest policy (see Register of Interests).
Clinical evidence
Included studies
A systematic review of the clinical 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, with reasons for their exclusion, are provided in appendix K.
Summary of clinical studies included in the evidence review
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 undertaken for this review (and so there are no forest plots in appendix E).
Quality assessment of clinical studies included in the evidence review
No studies were identified which were applicable to this review question and so there are no evidence profiles in appendix F.
Economic evidence
A systematic review of the economic literature was conducted but no economic studies were identified which were applicable to this review question.
See the literature search strategy in appendix B.
Economic model
No economic modelling was undertaken for this review because the committee agreed that other topics were higher priorities for economic evaluation.
Evidence statements
No clinical evidence was identified which was applicable to this review question.
The committee’s discussion of the evidence
Interpreting the evidence
The outcomes that matter most
The aim of this review was to assess the best method to induce labour following an intrauterine fetal death in a woman who had previously had a caesarean birth. The committee designated 2 critical outcomes: maternal mortality and uterine rupture. These outcomes were selected as the most direct indicators of safety of the different interventions considered for inducing labour in this group of women.
The committee identified 7 further outcomes as important, these were: vaginal birth in 24 hours, caesarean birth, depression/anxiety, postpartum haemorrhage, infection, maternal quality of life/experience of care, and pain. The main aim of induction of labour in intrauterine fetal death is to achieve a vaginal birth, without adverse effects for the woman, therefore the outcomes relating to mode of birth (vaginal birth in 24 hours and caesarean birth) were chosen. While the 24-hour limit may appear artificial, the committee agreed that this is a well-established outcome measure for assessing efficacy when inducing labour, and would provide a good indication of the relative efficacy of different methods.
Some of the recognised complications of induction of labour are: postpartum haemorrhage, infection, and pain, which may have lasting consequences on women’s wellbeing. Finally, maternal depression/anxiety and quality of life/experience of care were considered as important outcomes. Although the committee recognised the importance of these outcomes, they were aware that data on these were likely to be sparse, and unlikely to inform decision-making in a meaningful way, therefore they considered them important rather than critical outcomes.
The quality of the evidence
Randomised controlled trials were prioritised for inclusion in the review, and it was pre-specified that non-randomised comparative studies will be considered for inclusion if insufficient evidence from randomised controlled trials was identified.
The clinical evidence search identified no studies that met the inclusion criteria for this review. Most of the excluded studies were observational, mainly excluded either because the induction of labour took place in the 1st trimester or because women had not had a previous caesarean birth.
Benefits and harms
The committee discussed that management options following intrauterine fetal death in women who have had a previous caesarean birth include expectant management, caesarean birth, or induction of labour leading to a vaginal birth. Induction of labour may be an option in women who have had a previous lower segment caesarean birth, however the committee agreed that, based on their knowledge and experience, there was an increased risk of uterine rupture in this group of women, compared to those who do not have a scarred uterus, and that women should be advised of this risk.
The committee agreed, based on their experience, that women who underwent induction of labour following intrauterine fetal death (both those with and without a previous caesarean birth) should have their uterine contractions monitored and should receive one-to-one midwifery care to ensure any potential problems (such as hyperstimulation) were identified in a timely manner.
The committee agreed that induction of labour would only be an option in women who had had a previous caesarean birth using a lower segment incision, as they were aware from their own knowledge and experience that the risk of rupture would be too great in those with a midline incision, and that this should be specified in the recommendation. The committee emphasised that the woman’s personal circumstances and preferences should be discussed and supported when discussing the different management options.
Induction of labour leading to vaginal birth may involve less postpartum discomfort, a shorter hospital stay, and a reduced period of disability compared to caesarean birth. However, no evidence was identified on the most effective and safe method to induce labour following intrauterine death in women who have had a previous caesarean birth.
The committee discussed that the previous guideline had recommended the use of vaginal prostaglandin and that the ‘dose should be reduced’. The committee also discussed that in women without a previous caesarean birth, mifepristone 200mg (to sensitize the myometrium to prostaglandin-induced contractions) followed by a prostaglandin such as dinoprostone or misoprostol is used. The committee discussed the possibility of amending this regimen in women who had had a previous caesarean birth by using low doses of dinoprostone or misoprostol. However, the committee were aware that both dinoprostone and misoprostol are contraindicated in women with a previous caesarean birth and therefore they were not able to recommend a pharmacological method of induction.
The committee were aware that mifepristone (at the higher dose of 600 mg daily for 2 days) was approved for use on its own to induce labour, and was not contraindicated in women with a previous caesarean birth. However, no evidence for the safety or efficacy of mifepristone had been identified in women with a previous caesarean birth, and the committee were concerned that it may lead to a very prolonged induction process, which may be distressing for women. The committee therefore decided not to recommend mifepristone.
The committee noted that mechanical methods of induction, which did not lead to hyperstimulation, may be safe in women with a previous caesarean birth, and noted that the recommendations in the guideline for induction after caesarean birth (in women with a live baby) already stated this was an option, and so they made the same recommendation for use after an intrauterine fetal death.
The committee emphasised that this is an area that needs further research and acknowledged the emotional impact that intrauterine fetal death has on women and their relatives. They therefore made a research recommendation on this topic, with the aim of finding out the most effective and safe method to induce labour following intrauterine fetal death in women who have had a previous caesarean birth and therefore may have an increased risk of uterine rupture.
Cost effectiveness and resource use
The recommendations will raise awareness of the risks of uterine rupture in women undergoing induction of labour after a previous caesarean birth, and may increase the time required to counsel women, and lead to an increase in monitoring in women who do choose to be induced. This is not expected to lead to a substantial resource impact at national level.
Recommendations supported by this evidence review
This evidence review supports recommendations 1.2.30 to 1.2.32 and a research recommendation in the NICE guideline.
References
There were no studies identified for inclusion in this review.
Appendices
Appendix A. Review protocol
Appendix B. Literature search strategies
Appendix C. Clinical evidence study selection
Appendix D. Clinical evidence tables
Clinical evidence tables for review question: How should labour be induced in women with intrauterine fetal death who have had a previous caesarean birth?
No evidence was identified which was applicable to this review question.
Appendix E. Forest plots
Forest plots for review question: How should labour be induced in women with intrauterine fetal death who have had a previous caesarean birth?
No evidence was identified which was applicable to this review question.
Appendix F. GRADE tables
GRADE tables for review question: How should labour be induced in women with intrauterine fetal death who have had a previous caesarean birth?
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: How should labour be induced in women with intrauterine fetal death who have had a previous caesarean birth?
No economic evidence was identified for this review.
Appendix I. Health economic evidence profiles
Health economic evidence profiles for review question: How should labour be induced in women with intrauterine fetal death who have had a previous caesarean birth?
No economic evidence was identified for this review.
Appendix J. Health economic analysis
Health economic analysis for review question: How should labour be induced in women with intrauterine fetal death who have had a previous caesarean birth?
No health economic analysis was carried out for this review question.
Appendix K. Excluded studies
Excluded studies for review question: How should labour be induced in women with intrauterine fetal death who have had a previous caesarean birth?
Clinical studies
Table 3Excluded studies and reasons for their exclusion
| Study | Reason for exclusion |
|---|---|
| Abediasl, Z., Sheikh, M., Pooransari, P., Farahani, Z., & Kalani F (2016) Vaginal misoprostol versus intravenous oxytocin for the management of second-trimester pregnancies with intrauterine fetal death: A randomized clinical trial. Journal of Obstetrics and Gynaecology Research 3: 246–251 [PubMed: 26663590] |
- Exclude - incorrect population [Women were between 15 and 24 weeks gestation] |
| Abediasl, Z., Sheikh, M., Pooransari, P., Farahani, Z., & Kalani F (2016) Va ginal misoprostol versus intravenous oxytocin for the management of second-trimester pregnancies with intrauterine fetal death: A randomized clinical trial. Journal of Obstetrics and Gynaecology Research 42: 246–251 [PubMed: 26663590] |
- Exclude - incorrect population [Women were between 15 and 24 weeks gestation] |
| Bhattacharjee, N.; Ganguly, R. P.; Saha, S. P. (2007) Misoprostol for termination of mid-trimester post-Caesarean pregnancy. Australian and New Zealand Journal of Obstetrics and Gynaecology 47(1): 23–25 [PubMed: 17261095] |
- Exclude - incorrect population [Women were between 13 and 26 weeks gestation] |
| Boulot P, Hoffet M, Bachelard B, Lefort G, Hedon B, Laffargue F VJ (1993) Late vaginal induced abortion after a previous cesarean birth: potential for uterine rupture. Gynecologic and Obstetric Investigation 36(2): 87–90 [PubMed: 8225053] |
- Exclude - incorrect population [No IUFD, reason for termination of pregnancy were maternal diseases and fetal anomalies] |
| Boyle, A., Preslar, J. P., Hogue, C. J. et al. (2016) Clinical management of stillbirth. American Journal of Obstetrics and Gynecology 214(1 suppl1): 208 | - Exclude - conference abstract |
| Chapman, S. J., Crispens, M., Owen, J., & Savage K (1996) Complications of midtrimester pregnancy termination: The effect of prior cesarean delivery. American Journal of Obstetrics and Gynecology 175(4): 889–892 [PubMed: 8885742] |
- Exclude - incorrect population [Mean gestational age was 21.1 ± 3.1; not all women have had a previous caesarean birth] |
| Das, S. R., Parveen, T., Nahar, K. N. et al. (2013) Safety and efficacy of different doses of misoprostol in termination of intrauterine fetal death (IUFD) cases. Bangladesh journal of obstetrics and gynecology 28(1): 15–20 |
- Exclude - incorrect population [Women have not had a previous caesarean birth] |
| do Nascimento, M. I.; Cunha Ad.e, A.; Oliveira, S. R. (2014) Clinical management of the induction of labor in intrauterine fetal death: evaluation of incidence of cesarean section and related conditions. Revista brasileira de epidemiologia = Brazilian journal of epidemiology 17(1): 203–216 [PubMed: 24896793] |
- Exclude - incorrect population [Women have not had a previous caesarean birth] |
| Glanville, E. J. and Patel, R. R. (2010) Management of women with one or more previous Caesarean sections requiring induction of labour following midtrimester termination of pregnancy or intrauterine death. Archives of Disease in Childhood: Fetal and Neonatal Edition 95(suppl1) | - Exclude - conference abstract |
| Gomez Ponce de Leon, R.; Wing, D.; Fiala, C. (2007) Misoprostol for intrauterine fetal death. International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics 99suppl2: S190–3 [PubMed: 17961568] | - Exclude - conference abstract |
| Haque, L., Fatima, F., Mathur, M. et al. (2012) Medical management of late intrauterine death using a combination of mifepristone and misoprostol. International Journal of Gynecology and Obstetrics 119(suppl3): 810 | - Exclude - conference abstract |
|
Irct201307159568N (2013) Comparison of 2 different methods in Second trimester labor induction. http://www |
- Exclude - study protocol [Recruitment ended in 2014, published study is Abediasl 2016, which has been excluded from this review] |
| Pongsatha, S. and Tongsong, T. (2011) Outcomes of pregnancy termination by misoprostol at 14-32 weeks of gestation: A 10-year-experience. Journal of the Medical Association of Thailand 94(8): 897–901 [PubMed: 21863669] |
- Exclude - incorrect population [Women were between 14 and 32 weeks gestation] |
| Reichman, O.; Cohen, M.; Beller, U. (2007) Prostaglandin E2 mid-trimester evacuation of the uterus for women with a previous cesarean section. International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics 96(1): 32–3 [PubMed: 17189634] | - Exclude - conference abstract |
| Romero, V., Salari, K., Ehrenberg-Buchner, S. et al. (2012) Obstetric outcomes in women with intrauterine fetal demise and prior cesarean delivery. American Journal of Obstetrics and Gynecology 206(1 suppl1): 83 [PubMed: 21963098] | - Exclude - conference abstract |
Table 4Studies excluded from the economic review
| Study | Reason for exclusion |
|---|---|
| Cowett A A, Golub R M, Grobman W A. Cost-effectiveness of dilation and evacuation versus the induction of labor for second-trimester pregnancy termination. American Journal of Obstetrics and Gynecology 2006; 194(3): 768–773 [PubMed: 16522411] | Exclude - wrong indication, intervention is for 2nd trimester termination not IUFD |
Appendix L. Research recommendations
Final
Evidence review underpinning recommendations 1.2.30, 1.2.32 and a research recommendation in the NICE guideline
This evidence review was developed by the National Guideline Alliance which is a part of the Royal College of Obstetricians and Gynaecologists
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.
- Supplement 1: Glossary and abbreviations (PDF)
- Supplement 2: National Guideline Alliance and Technical Support Unit Staff (PDF)
- Supplement 3: Evidence tables for pharmacological and mechanical methods for induction of labour (PDF)
- Supplement 4: GRADE tables for pharmacological and mechanical methods for induction of labour (PDF)
- Supplement 5: Development of the guideline and methods (PDF)
- Supplement 6: Summary of deleted and amended recommendations (PDF)
- Methods of term labour induction for women with a previous caesarean section.[Cochrane Database Syst Rev. 2017]Methods of term labour induction for women with a previous caesarean section.West HM, Jozwiak M, Dodd JM. Cochrane Database Syst Rev. 2017 Jun 9; 6(6):CD009792. Epub 2017 Jun 9.
- Pharmacological and mechanical interventions for labour induction in outpatient settings.[Cochrane Database Syst Rev. 2017]Pharmacological and mechanical interventions for labour induction in outpatient settings.Vogel JP, Osoti AO, Kelly AJ, Livio S, Norman JE, Alfirevic Z. Cochrane Database Syst Rev. 2017 Sep 13; 9(9):CD007701. Epub 2017 Sep 13.
- Low-dose oral misoprostol for induction of labour.[Cochrane Database Syst Rev. 2021]Low-dose oral misoprostol for induction of labour.Kerr RS, Kumar N, Williams MJ, Cuthbert A, Aflaifel N, Haas DM, Weeks AD. Cochrane Database Syst Rev. 2021 Jun 22; 6(6):CD014484. Epub 2021 Jun 22.
- Guidelines for vaginal birth after previous Caesarean birth.[J Obstet Gynaecol Can. 2004]Guidelines for vaginal birth after previous Caesarean birth.Martel MJ, MacKinnon CJ, Clinical Practice Obstetrics Committee of the Society of Obstetricians and Gynaecologiests of Canada. J Obstet Gynaecol Can. 2004 Jul; 26(7):660-83; quiz 684-6.
- Methods of term labour induction for women with a previous caesarean section.[Cochrane Database Syst Rev. 2013]Methods of term labour induction for women with a previous caesarean section.Jozwiak M, Dodd JM. Cochrane Database Syst Rev. 2013 Mar 28; (3):CD009792. Epub 2013 Mar 28.
- Intrauterine fetal death after previous caesarean birthIntrauterine fetal death after previous caesarean birth
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