Cervical ripening with a double balloon device for 6 h in patients with a long cervix: Secondary analysis of a randomized controlled trial
Year: 2024
Type: article
Abstract: OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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. REGISTRATION AT CLINICAL TRIALS: https://classic. CLINICALTRIALS: gov/ct2/show/NCT03045939.
DOI: 10.1002/ijgo.15955
Language: English
Subfield: Obstetrics and Gynecology
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W4403733718