Misoprostol monotherapy versus adjunctive mechanical cervical ripening with Foley catheter or Dilapan-S for second-trimester termination of pregnancy: A randomized controlled trial.
5 affiliations
- 1Department of Obstetrics and Gynecology, School of Medicine, Dezful University of Medical Sciences, Dezful, Iran.
- 2Student Research Committee, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.
- 3Department of Midwifery, Mara.C., Islamic Azad University, Marand, Iran.
- 4Faculty of Nursing, Dezful University of Medical Sciences, Dezful, Iran.
- 5Student Research Committee, Dezful University of Medical Sciences, Dezful, Iran.
Abstract
Background
In regions where mifepristone access is legally or logistically constrained, second-trimester pregnancy termination predominantly relies on misoprostol-only regimens. However, these protocols are often associated with a prolonged induction-to-abortion interval (IAI). This study evaluated whether integrating mechanical cervical ripening agents-specifically Foley catheters or Dilapan-S rods-could enhance the clinical efficiency of misoprostol-induced terminations in mifepristone-restricted settings.Materials and methods
In this single-center, open-label randomized controlled trial (February-October 2023), 90 women with singleton pregnancies between 13 + 0 and 20 + 6 weeks' gestation were randomly assigned (1:1:1 ratio) to one of three groups: (1) vaginal misoprostol monotherapy (400 µg every 3 h); (2) misoprostol plus a 24F Foley catheter (balloon inflated to 40 mL); or (3) misoprostol following a 4-h cervical preparation with a Dilapan-S osmotic dilator. Sample size was calculated to detect a 30% reduction in median IAI (α = 0.05, β = 0.20), requiring 75 participants; 90 were enrolled to account for 20% attrition. Randomization employed computer-generated blocks with allocation concealment via SNOSE (sequentially numbered, opaque, sealed envelopes). Primary outcomes were IAI and total procedure time. Secondary outcomes included 24-h success rate, cumulative misoprostol dose, adverse events, and patient-reported acceptability. Statistical analyses used Kruskal-Wallis, Chi-square, and Kaplan-Meier log-rank tests, with significance defined as P < 0.05.Results
Median IAI did not differ significantly among groups (misoprostol: 600 min, Foley: 714 min, Dilapan-S: 698 min; P = 0.54). Total procedure time was significantly longer in the Dilapan-S group (938 min) compared with misoprostol alone (600 min) and Foley catheter (714 min; P = 0.02). The 24-h success rate was 67.5% overall, with no significant between-group differences (P = 0.26). No major complications occurred.Conclusion
Adjunctive use of Foley catheters or Dilapan-S does not accelerate the induction-to-abortion process in second-trimester terminations compared with misoprostol monotherapy in mifepristone-restricted settings. Given the significantly longer total procedure time of Dilapan-S and its 15-fold higher cost without clinical benefit, vaginal misoprostol monotherapy remains the most pragmatic and cost-effective strategy. Larger multicenter trials are warranted to detect potentially subtle differences in clinical efficacy.Trial registration
Iranian Registry of Clinical Trials (IRCT20210516051312N2).
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BibTeX
@article{torabifar2026misoprostol,
title = {{Misoprostol monotherapy versus adjunctive mechanical cervical ripening with Foley catheter or Dilapan-S for second-trimester termination of pregnancy: A randomized controlled trial.}},
author = {Neda Torabifar and Fatemeh Yousefi and Shahla Faal Siahkal and Sara Kord and Salimeh Moradinasab},
journal = {Journal of education and health promotion},
year = {2026},
month = sep,
doi = {10.4103/jehp.jehp_55_26},
url = {https://europepmc.org/article/MED/42923805},
note = {CC BY-NC-ND},
}
RIS
TY - JOUR
TI - Misoprostol monotherapy versus adjunctive mechanical cervical ripening with Foley catheter or Dilapan-S for second-trimester termination of pregnancy: A randomized controlled trial.
AU - Neda Torabifar
AU - Fatemeh Yousefi
AU - Shahla Faal Siahkal
AU - Sara Kord
AU - Salimeh Moradinasab
PY - 2026
DA - 2026/09/30
JO - Journal of education and health promotion
DO - 10.4103/jehp.jehp_55_26
UR - https://europepmc.org/article/MED/42923805
AB - Background In regions where mifepristone access is legally or logistically constrained, second-trimester pregnancy termination predominantly relies on misoprostol-only regimens. However, these protocols are often associated with a prolonged induction-to-abortion interval (IAI). This study evaluated whether integrating mechanical cervical ripening agents-specifically Foley catheters or Dilapan-S rods-could enhance the clinical efficiency of misoprostol-induced terminations in mifepristone-restricted settings.Materials and methods In this single-center, open-label randomized controlled trial (February-October 2023), 90 women with singleton pregnancies between 13 + 0 and 20 + 6 weeks' gestation were randomly assigned (1:1:1 ratio) to one of three groups: (1) vaginal misoprostol monotherapy (400 µg every 3 h); (2) misoprostol plus a 24F Foley catheter (balloon inflated to 40 mL); or (3) misoprostol following a 4-h cervical preparation with a Dilapan-S osmotic dilator. Sample size was calculated to detect a 30% reduction in median IAI (α = 0.05, β = 0.20), requiring 75 participants; 90 were enrolled to account for 20% attrition. Randomization employed computer-generated blocks with allocation concealment via SNOSE (sequentially numbered, opaque, sealed envelopes). Primary outcomes were IAI and total procedure time. Secondary outcomes included 24-h success rate, cumulative misoprostol dose, adverse events, and patient-reported acceptability. Statistical analyses used Kruskal-Wallis, Chi-square, and Kaplan-Meier log-rank tests, with significance defined as P < 0.05.Results Median IAI did not differ significantly among groups (misoprostol: 600 min, Foley: 714 min, Dilapan-S: 698 min; P = 0.54). Total procedure time was significantly longer in the Dilapan-S group (938 min) compared with misoprostol alone (600 min) and Foley catheter (714 min; P = 0.02). The 24-h success rate was 67.5% overall, with no significant between-group differences (P = 0.26). No major complications occurred.Conclusion Adjunctive use of Foley catheters or Dilapan-S does not accelerate the induction-to-abortion process in second-trimester terminations compared with misoprostol monotherapy in mifepristone-restricted settings. Given the significantly longer total procedure time of Dilapan-S and its 15-fold higher cost without clinical benefit, vaginal misoprostol monotherapy remains the most pragmatic and cost-effective strategy. Larger multicenter trials are warranted to detect potentially subtle differences in clinical efficacy.Trial registration Iranian Registry of Clinical Trials (IRCT20210516051312N2).
SN - 2277-9531
SN - 2319-6440
ER -