European Journal of Obstetrics & Gynecology and Reproductive Biology
Review articleRisk of maternal, fetal and neonatal complications associated with the use of the transcervical balloon catheter in induction of labour: A systematic review☆
Introduction
Ripening of the unfavourable cervix and induction of labour are worldwide commonly performed obstetrical procedures. In well-resourced countries, labour is induced in 20–25% of all pregnancies. [1], [2] In case of an unripe cervix, induction of labour starts with cervical ripening for which a broad variety of both pharmacological agents such as prostaglandins and mechanical methods such as the balloon catheter are currently available. [2], [3], [4] Recent randomized controlled trials (RCTs) have shown that the use of a balloon catheter has benefits over the use of both vaginal prostaglandin E2 gel and vaginal misoprostol in terms of side-effects and safety profile with a comparable effectiveness, specifically with respect to uterine hyperstimulation resulting in fetal distress and maternal haemorrhage. [4], [5] These findings have led to the revival of the use of a balloon catheter for induction of labour.
Many studies report on a limited spectrum of adverse events with the use of the balloon catheter, but they are often not powered to draw conclusions about its safety for clinical use. [6], [7], [8] Since the balloon catheter is commonly used for labour induction, adequate information on its safety is of great importance. After reviewing current literature, we have been unable to identify a systematic review that includes an extensive pooled risk analysis of all possible maternal, fetal and neonatal complications associated with the use of a balloon catheter for labour induction. We therefore aimed to conduct a review with a pooled risk analysis in order to assess the safety of the transcervical balloon catheter for labour induction.
Section snippets
Data sources
We searched Medline, EMBASE, the Cumulative Index to Nursing and Allied Health Literature (CINAHL) and the Cochrane electronic databases. Our search terms included ‘induction of labour’, ‘cervical ripening’, ‘balloon catheter’, ‘Foley balloon’, and ‘transcervical balloon’, and were conducted in consultation with an experienced medical librarian. We did not use date or language restrictions. References from review articles were manually screened for relevant studies. Appendix S1 contains
Results
A total of 585 studies were revealed after removal of duplicates. These studies were screened for eligibility by title and abstract, after which 136 studies seemed eligible for full-text assessment (Fig. 1). Of these 136 studies, 52 were excluded because: the full text was not traceable (n = 22); the balloon catheter was concurrently/consecutive used with other induction agents (n = 8); the study was not yet published and hence had not been subject to peer review (n = 6); the indication for labour
Comment
This systematic review evaluated the safety of induction of labour with a transcervical balloon catheter by addressing a wide range of potential adverse events using a pooled risk assessment. The overall risk of maternal infection was 11% and 3.3% for the intrapartum and postpartum periods respectively. The risk of neonatal infection/sepsis was 4.6%. Uterine contraction abnormalities occurred in 2.7% of the women. The risk for non-reassuring fetal heart rate and fetal distress was 11% and 10%
Strengths and limitations
The broad spectrum of all adverse events addressed in this review provides the most comprehensive safety profile of the use of the balloon catheter for cervical ripening yet published. The inclusion of 84 studies with a total of 13,791 women makes our pooled risk assessment highly valid. We did not limit our search to English published articles only, resulting in more complete information gathering and less bias. In addition, we subgrouped all possible outcomes in order to portray our results
Interpretation
The risk of infection with the use of the balloon catheter for labour induction remains a topic of debate. A recently published meta-analysis evaluating the Foley catheter as a source of infection showed pooled risks for maternal infections of 8.8%, chorioamnionitis 7.2%, endometritis 3.8% and neonatal infections 3.2% [17]. The overall intrapartum infection rates in this review included chorioamnionitis, which might have increased our reported rate. In contrast, we found a lower rate of
Conclusion
This review shows clinically significant risks associated with the process of induction of labour with a balloon catheter and provides health care workers with the most complete safety profile possible from the current literature which can be useful for clinical decision making as well as for obtaining informed consent. In terms of future research, we recommend use of predefined standardized core outcomes in order to ensure consistent synthesis of evidence by providing more homogeneous data and
Conflict of interest
Ben Mol provides consultancy to ObsEva, Guerbet and Merck.
Funding
There were no financial supports for this review.
Author contribution
JG, MD, DT and BWM equally conceived and designed the review. JG and MD carried out the literature search, extracted data, performed the data analysis and drafted the article. JG and MD were responsible for the integrity of the paper. BMW, CW and DT provided subsequent writing and editing. JG, MD, BWM, CW and DT were responsible for the revision.
Ethical approval
There was no need for ethics approval since this is a systematic review.
Acknowlegdements
We would like to thank Michael Draper, Medical Librarian, for his contribution to our search strategy. BWM is supported by a NHMRC Practitioner Fellowship (GNT1082548).
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Conducted at: The University of Adelaide, North Terrace, Adelaide, South Australia 5005, Australia
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Both authors contributed equally to this review.