1. Cervical ripening with a double balloon device for 6 h in patients with a long cervix: Secondary analysis of a randomized controlled trial.
- Author
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Sammour, Rami, Dikopoltsev, Elena, Sagi, Shlomi, Vitner, Dana, and Bleicher, Inna
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TRANSVAGINAL ultrasonography , *INDUCED labor (Obstetrics) , *RANDOMIZED controlled trials , *SECONDARY analysis , *OXYTOCIN , *CONTROL groups - Abstract
Objective Methods Results Conclusion Registration at Clinical Trials To examine whether cervical ripening with a double balloon device for 6 h is as effective as 12 h in patients with a cervical length ≥ 30 mm measured on transvaginal ultrasound before induction of labor, and to determine whether patients with a long cervix need to have the balloon placed for a longer time.This is a secondary analysis of data from a randomized controlled trial that compared maternal and neonatal outcomes between women undergoing cervical ripening with a double balloon device for 6 h (study group) versus 12 h (control group). In this secondary analysis, we included only patients who had cervical length ≥ 30 mm measured on transvaginal ultrasound on admission. Our primary outcome was a Bishop score change after removal of the device. Secondary outcomes included insertion to delivery interval, mode of delivery, and oxytocin infusion duration.Sixty‐seven women met the inclusion criteria and were included in the analysis: 33 in the 6‐h group and 34 in the 12‐h group. Maternal characteristics were similar between both groups. Bishop score difference between the preinsertion and the postremoval scores were similar in the two groups (2.67 ± 1.8 vs. 2.53 ± 1.69, P = 0.76), while insertion to delivery time was 10 h shorter in the 6‐h group (20.95 vs. 31.21, P = 0.02; mean difference, −10.26 [95% CI, −19.0 to −1.51]). The other secondary outcomes remained similar in both groups.In women undergoing induction of labor who have a cervical length ≥ 30 mm measured on admission transvaginal ultrasound, removing a double balloon device after 6 h achieved similar Bishop score changes as removal after 12 h, but significantly reduced the time to delivery.https://classic.clinicaltrials.gov/ct2/show/NCT03045939. [ABSTRACT FROM AUTHOR]
- Published
- 2024
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