scholarly journals Double balloon catheter (+oxytocin) versus dinoprostone vaginal insert for term rupture of membranes: a randomized controlled trial (RUBAPRO)

Author(s):  
Eric Devillard ◽  
Fanny Petillon ◽  
Marion Rouzaire ◽  
Bruno Pereira ◽  
Marie Accoceberry ◽  
...  

Objective: To demonstrate that a double balloon catheter combined with oxytocin decreases time between induction of labour and delivery (TID) as compared to a vaginal dinoprostone insert in cases of PROM at term. Design: Prospective, randomized, controlled trial. Setting: French university hospital Population: Patients undergoing labour induction for PROM at term with unfavorable cervix. Methods: We compared the double balloon catheter over a period of 12 hours with adjunction of oxytocin 6 hours after catheter insertion, versus dinoprostone vaginal insert. After device ablation, cervical ripening continued only with oxytocin. Main outcome measures: The primary outcome was TID. Secondary outcomes concerned delivery mode, maternal and fetal outcome and were adjusted for parity. Results: 40 patients per group were randomized. Each group had similar baseline characteristics. The study failed to demonstrate reduced TID (16.2 vs 20.2 hours, ES = 0.16 (-0.27 to 0.60), p=0.12) in catheter group versus dinoprostone except in nulliparous women (17.0 vs 26.5 hours, ES = 0.62 (0.10 to 1.14), p=0.006). The rate of vaginal delivery <24h significantly increased with combined induction (88.5% vs 66.6%, p=0.03). No statistical difference was observed concerning caesarean rate (12.5% vs 17.5%, p>0.05), chorioamnionitis (0% vs 2.5%, p=1), postpartum endometritis, maternal or neonatal outcomes. Procedure-related pain and tolerance to devices were found to be similar for the two methods. Conclusion: The double balloon catheter combined with oxytocin is an alternative for cervical ripening in case of PROM at term, and may reduce TID in nulliparous women.

2017 ◽  
Vol 35 (03) ◽  
pp. 225-232 ◽  
Author(s):  
Maritza Gonzalez ◽  
Wei-Hsuan Lo-Ciganic ◽  
Kathryn Reed ◽  
Meghan Hill

Objective This article aims to evaluate whether the use of a double-balloon catheter with oral misoprostol results in a lower rate of cesarean and shorter times to delivery than the use of the double-balloon catheter with oral placebo. Study Design In a double-blind randomized controlled trial, a double-balloon catheter was used for induction of labor with two doses of either 50 µg of misoprostol or placebo. Outcomes included cesarean rate, time to vaginal delivery, change in Bishop's score, and oxytocin usage. Results A total of 343 women were screened and 199 randomized: 99 to the misoprostol arm and 100 to the placebo arm. Cesarean delivery rate was not different between the groups (misoprostol: 13.1% vs. placebo: 17.0%, p = 0.45). Time to vaginal delivery was significantly shorter (mean: 14.6 ± 6.9 vs. 20.8 ± 13.8 hours, p < 0.0001), change in Bishop's score was significantly greater (median: 5 vs. 4 points, p = 0.005), and use of oxytocin was significantly less frequent (86.9 vs. 98.0% patients, p = 0.01) in the misoprostol group. Conclusion The use of a double-balloon catheter with oral misoprostol for induction did not reduce the cesarean delivery rate, but did result in shorter labors, a greater increase in Bishop's score, and a lower need for oxytocin use.


Author(s):  
Nnabugwu Alfred Adiele ◽  
Christian C. Mgbafulu ◽  
Arinze Chidiebere Ikeotuonye ◽  
Christian Chidebe Anikwe ◽  
Joshua Adeniyi Adebayo ◽  
...  

Background: The ripeness of the cervix is an important prerequisite to a successful labour induction. Use of extra-amniotic Foley catheter is a mechanical method of cervical ripening with proven efficacy. This study compared the difference in efficacy between 30 ml and 60 ml of water for inflation of Foley catheter balloon when used for cervical ripening during induction of labour.Methods: A single-blind randomized controlled study where 260 term pregnant women with intact membranes and unfavourable cervix were selected for induction of labour and randomized into two equal groups (30 ml- and 60 ml- groups) from October, 2019 to July 2020. Each participant had cervical ripening with the catheter bulb inflated with either 30 ml or 60 ml of sterile water (as assigned to the individual). After achieving favourable cervix (BS ≥6), oxytocin titration was commenced and the labour monitored with the outcomes well documented and statistically analysed.Results: Mean duration to favourable Bishop Score significantly reduced in the 60 ml group (10.8 hours±2.99) as against 12.7 hours±10.0 in 30ml group (p=0.038). Mean duration of active phase of labour was significantly reduced in 60 ml group (5.6 hours±2.4) as against 8.4 hours±3.2 in 30 ml group (p=0.010). Caesarean delivery rate was significantly reduced in the 60 ml groups (p=0.027).Conclusions: The use of 60 ml inflated Foley’s balloon catheter when compared with 30mls to ripen the cervix effectively reduced the duration to favourable Bishop Score, duration of the active phase of labour and the rate of Caesarean sections.  


2021 ◽  
Vol 224 (2) ◽  
pp. S302-S303
Author(s):  
Roy Lauterbach ◽  
Hanin Dabaja ◽  
Nadir Ganem ◽  
Ron Beloosesky ◽  
Yuval Ginsberg ◽  
...  

Sign in / Sign up

Export Citation Format

Share Document