Balloon catheter plus concurrent vaginal misoprostol versus vaginal misoprostol alone for cervical ripening in induction of labor: A systematic review and an individual participant data meta-analysis of randomized controlled trials.
Malitha Patabendige, Fei Chan, Zainab Al-Ibraheemi et al.
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In 30 seconds
This systematic review and individual participant data meta-analysis of randomized trials compared a balloon catheter plus concurrent low-dose vaginal misoprostol with misoprostol alone for cervical ripening in viable singleton pregnancies undergoing labor induction. The analysis included five trials and 649 participants after trustworthiness checks. Vaginal delivery rates were comparable (adjusted odds ratio 0.97, 95% CI: 0.30; 3.12), with very low certainty of evidence. The combined method was associated with less uterine hyperstimulation and meconium-stained liquor, but the authors considered safety uncertain because of limited data retrieval and concerns about trial trustworthiness.
Key findings
- Vaginal delivery was comparable between groups (adjusted odds ratio 0.97, 95% CI: 0.30; 3.12; very low certainty).
- The combined group had less uterine hyperstimulation (adjusted odds ratio 0.20, 95% CI: 0.10; 0.41).
- Meconium-stained liquor was less frequent with the combined method (adjusted odds ratio 0.23, 95% CI 0.07; 0.77).
- The IPD analysis included five trials (649 participants); 13 of 22 identified trials did not meet trustworthiness criteria.
Why it matters
The findings suggest that adding a balloon catheter to vaginal misoprostol does not clearly improve vaginal delivery rates. Possible reductions in uterine hyperstimulation and meconium-stained liquor may be relevant to safety, but the evidence is too uncertain to establish a reliable safety advantage. The substantial trustworthiness concerns among trials also underscore the importance of cautious interpretation of evidence on combined cervical-ripening methods.
What to keep in mind
Only five trials with 649 participants contributed to the IPD analysis, and the evidence for key outcomes was rated very low certainty. Many identified trials did not meet trustworthiness criteria, and data retrieval was limited.