Transcervical Foley Catheter With and Without Oxytocin for Cervical Ripening

Pettker, Christian M.; Pocock, Sean B.; Smok, Dorothy P.; Lee, Shing M.; Devine, Philip E.

doi:10.1097/aog.0b013e31817615a0

Cited by 57 publications

(8 citation statements)

References 13 publications

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“…As concomitant administration of prostaglandin and oxytocin is strictly forbidden to prevent the risk of tachysystolia or uterine hyperstimulation [ 21 ], oxytocin may be administrated earlier when used in combination with mechanical devices, positively impacting the period of time before birth. Finally, the combination of catheter plus oxytocin has not been shown to impact rates of caesarean section, postpartum hemorrhage, or neonatal complications [ 19 , 20 , 22 ].…”

Section: Discussionmentioning

confidence: 99%

Double Balloon Catheter (Plus Oxytocin) versus Dinoprostone Vaginal Insert for Term Rupture of Membranes: A Randomized Controlled Trial (RUBAPRO)

Devillard

Petillon

Rouzaire

et al. 2022

JCM

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Background: The aim of this study is to demonstrate that a double balloon catheter combined with oxytocin decreases time between induction of labor and delivery (TID) as compared to a vaginal dinoprostone insert in cases of premature rupture of membranes at term. Methods: This is a prospective, randomized, controlled trial including patient undergoing labor induction for PROM at term with an unfavorable cervix in Clermont-Ferrand university hospital. We compared the double balloon catheter over a period of 12 h with adjunction of oxytocin 6 h after catheter insertion versus dinoprostone vaginal insert. After device ablation, cervical ripening continued only with oxytocin. The main outcome was TID. Secondary outcomes concerned delivery mode, as well as 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 versus 20.2 h, ES = 0.16 (−0.27 to 0.60), p = 0.12) in the catheter group versus dinoprostone except in nulliparous women (17.0 versus 26.5 h, ES = 0.62 (0.10 to 1.14), p = 0.006). The rate of vaginal delivery <24 h significantly increased with combined induction (88.5% versus 66.6%, p = 0.03). No statistical difference was observed concerning caesarean rate (12.5% versus 17.5%, p > 0.05), chorioamnionitis (0% versus 2.5%, p = 1), postpartum endometritis, or maternal or neonatal outcomes. Procedure-related pain and tolerance to devices were found to be similar for the two methods. Interpretation: 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.

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Section: Discussionmentioning

confidence: 99%

Double Balloon Catheter (Plus Oxytocin) versus Dinoprostone Vaginal Insert for Term Rupture of Membranes: A Randomized Controlled Trial (RUBAPRO)

Devillard

Petillon

Rouzaire

et al. 2022

JCM

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“…For example, a trial comparing the Foley catheter with or without oxytocin used a low-dose oxytocin regimen for induction and augmentation that was specific to that institution. 81 This trial found that the addition of oxytocin to the Foley catheter did not shorten the time to delivery. However, subsequent studies that used a higher dose of oxytocin per institutional protocol reported a shorter time to delivery with the combination method.…”

Section: Limitations Of Trials On Labor Inductionmentioning

confidence: 93%

“…Of the 103 trials identified, just 63 were RCTs. 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 The majority of RCTs were single-center trials conducted in academic hospitals, which can limit the generalizability of the results to other community-based populations. Among the 12 multicenter trials, the number of centers ranged from 2 to 49 and tended to include both university-affiliated and community hospitals.…”

Section: Limitations Of Trials On Labor Inductionmentioning

confidence: 99%

“…The trials in the U.S. assessed the Foley catheter in combination with oxytocin or misoprostol versus various comparators. The Foley catheter plus oxytocin was compared with the Foley catheter alone ( n = 1), 81 sequential use of the Foley catheter and oxytocin ( n = 2), 25 27 or a different oxytocin dosing protocol (i.e., fixed vs. incremental low-dose oxytocin; n = 1). 58 The Foley catheter plus vaginal misoprostol was compared with vaginal misoprostol alone ( n = 1); 49 another clinical trial compared the Foley catheter plus oral misoprostol versus vaginal misoprostol alone.…”

Section: Limitations Of Trials On Labor Inductionmentioning

confidence: 99%

“…In addition, of the five trials identified in our search that included prespecified subgroup analyses, 25 36 39 81 84 only two were powered to detect differences between groups. While subgroup analyses can be useful for evaluating treatment effects in specific patient populations (e.g., nulliparous vs. multiparous women), they should be identified a priori rather than data driven.…”

Section: Limitations Of Trials On Labor Inductionmentioning

confidence: 99%

See 2 more Smart Citations

Challenges and Limitations of Clinical Trials on Labor Induction: A Review of the Literature

Viteri

Sibai

2018

AJP Rep

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Induction of labor is a common obstetric procedure performed in nearly a quarter of all deliveries in the United States. Pharmacological (prostaglandins, oxytocin) and/or mechanical methods (balloon catheters) are commonly used for labor induction; however, there is ongoing debate as to which method is the safest and most effective. This narrative review discusses key limitations of published trials on labor induction, including the lack of well-designed randomized controlled trials directly comparing specific methods of induction, heterogeneous trial populations, and wide variation in the protocols used and outcomes reported. Furthermore, the majority of published trials were underpowered to detect significant differences in the most clinically relevant efficacy and safety outcomes (e.g., cesarean delivery, neonatal mortality). By identifying the limitations of labor induction trials, we hope to highlight the importance of quality published data to better inform guidelines and drive evidence-based treatment decisions.

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