Trial reportActa obstetricia et gynecologica Scandinavica2025
Comparison of balloon catheter, oral misoprostol, or combination of both for cervical ripening in late-term and post-term nulliparous women: A Finnish randomized controlled multicenter pilot trial.
Trial report in Acta obstetricia et gynecologica Scandinavica, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
6 citing papers in PubMed, 1 synthesis or guideline pooled it.
- 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.International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2026Pooled it
- Outpatient cervical ripening with Foley balloon or mifepristone: Insights into the time taken to reach the active phase of labor.International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2026Trial
- Comparison of balloon catheter, oral misoprostol, or combination of both for cervical ripening in late-term and post-term nulliparous women: A Finnish randomized controlled multicenter pilot trial.Acta obstetricia et gynecologica Scandinavica · 2025Trial
- Comparison of the efficacy and safety of misoprostol and a Cook cervical ripening double-balloon catheter, alone and in combination, for cervical ripening and induction of labor.Frontiers in medicine · 2026Article
- Double-Balloon Catheter Alone or Combined with Oxytocin, Dinoprostone, or Misoprostol for Labor Induction in Late- and Post-Term Pregnancies: A Retrospective Cohort Study.International journal of women's health · 2026Article
- Comparative Effectiveness, Safety, and Cost-Effectiveness of Labour Induction Methods: A Systematic Review.Cureus · 2025Review
Corrections and comments
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Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionNulliparous women beyond term have high rates of induction failure. The aim of this study was to compare delivery outcomes for balloon catheter, misoprostol, and combination of both in nulliparous late- and post-term women with unfavorable cervices. We intended to explore whether the combination strategy has lower cesarean section rate and is as safe as either method alone. MATERIAL AND
methodsThe randomized multicenter pilot trial was carried out in the five university hospitals and the largest secondary care hospital of Finland March 1, 2018-March 31, 2022. A total of 273 nulliparous women with viable singleton fetus in cephalic presentation, intact amniotic membranes, and an unfavorable cervix at 41 + 0 gestational weeks were included. The study protocol was registered in the ISCTN registry (ISRCTN83219789). The women were randomized into cervical ripening by balloon catheter, oral misoprostol 50 μg every 4 h, or the combination use of both. The primary outcomes of the study were the rates of cesarean section and composite of adverse neonatal outcomes (5-min Apgar score <7, umbilical artery pH ≤7.05, or NICU admission).
resultsNinety-seven women (35.5%) were allocated in the balloon catheter arm, 94 (34.4%) in the oral misoprostol arm, and 82 (30.0%) in the combination treatment arm. The rates of cesarean section (balloon catheter 23.7%, n = 23/97, vs. oral misoprostol 24.5%, n = 23/94, vs. combination 17.1%, n = 14/82) or composite adverse neonatal outcome (7.2% vs. 7.4% vs. 7.3%, respectively) were not statistically significantly different between the groups. The median (interquartile range) induction to delivery interval was the shortest in the combination treatment, 21.7 (15.1-33.2) h compared to balloon catheter 31.7 (21.9-44.5) h; p < 0.01 or oral misoprostol 37.0 (26.7-60.3) h; p < 0.01. The proportion of women with induction to delivery interval ≤24 h was significantly higher in the combination arm compared to balloon catheter (54.4% vs. 31.1%; p < 0.01) or oral misoprostol (54.4% vs. 21.1%; p < 0.001).
conclusionsOur findings confirm the effectiveness of combining balloon catheter and oral misoprostol for cervical ripening, showing shorter induction to delivery interval and comparable rates of cesarean section and neonatal outcomes compared to either method alone. These results advocate for a shift toward adopting combination strategy in the induction of nulliparous late- and post-term women.
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