Double balloon catheters: A promising tool for induction of labor in multiparous women with unfavorable cervices (original) (raw)
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Journal of the Turkish-German Gynecological Association
Objective: To compare the effectiveness and safety of oxytocin and a cervical ripening balloon in women with unfavorable cervices for inducing labor. Material and Methods: A total of eighty pregnant women between 37-41 gestational weeks having singleton pregnancies and intact membranes with unfavorable cervices were randomized into two groups, cervical ripening balloon (n=40) and oxytocin infusion (n=40). The primary outcomes were the labor time and the route of delivery. Secondary outcomes were the effect of parity on time of labor, and obstetric and perinatal outcomes. Results: The median time to delivery was 9.45 hours in cervical ripening balloon group and 13.2 hours in the oxytocin group in multiparous women. The differences were statistically significant (p<0.001). The median time until delivery was 11.48 hours in cervical ripening balloon group and 13.46 hours in the oxytocin group; the differences were statistically significant (p<0.001). Cesarean delivery ratios were similar in both groups (p=0.431). Conclusion: The results of the present study are promising for balloon use, especially in multiparous women. It is beneficial to support these data with wide ranging population-based studies.
Single-Balloon Compared With Double-Balloon Catheters for Induction of Labor
Obstetrics & Gynecology, 2011
To estimate the efficacy of a single-balloon catheter compared with a double-balloon catheter among women with unfavorable cervices undergoing induction of labor. METHODS: This prospective randomized study was conducted at a university teaching medical center between June 2008 and December 2010. Pregnant women admitted for induction of labor with a live singleton gestation in cephalic presentation with intact membranes and a Bishop score of 6 or less were randomly assigned for cervical ripening by a single-balloon catheter or a double-balloon catheter. The primary outcome was the length of time from catheter insertion until delivery. The secondary outcome was mode of delivery. RESULTS: Of 368 eligible women screened during the study period, 293 were included in the final analysis; 145 were randomly assigned to receive a single-balloon catheter and 148 received a double-balloon catheter. Demographic and obstetric parameters were comparable between the two groups. Length of time from catheter insertion until delivery was 19.4 (؎6.0) and 19.1 (؎6.8) hours among the single-balloon and the double-balloon catheter groups, respectively (P.)08.؍ Length of time did not differ when primiparous women were analyzed separately. Incidence of cesarean delivery was 10.3% and 17.6% among the single-balloon and double-balloon catheter groups, respectively (P.)90.؍ The incidence of either vacuum deliveries or cesarean deliveries was significantly lower among the single-balloon group (14.4%) compared with the doubleballoon catheter group (25.7%; odds ratio 0.49, 95% confidence interval 0.26-0.92; P.)20.؍ CONCLUSION: Both the single-balloon and double-balloon catheters are equally efficacious for inducing labor. The double-balloon catheter may be associated with more operative deliveries.
Acta Obstetricia et Gynecologica Scandinavica, 2019
Introduction: To compare efficacy and maternal-neonatal morbidity between balloon catheter and oxytocin for induction of labor in women with a previous cesarean section and an unfavourable cervix. Material and methods: This open label randomised controlled trial took place in seven French hospitals. Inclusion criteria were medical indication for labor induction in pregnant women, ≥37 weeks, with lower segment cesarean section, Bishop score ≤4, no pre-labour rupture of membranes, singleton fetus in cephalic presentation. Women were allocated randomly to induction with a 50-ml balloon catheter for 12 hours or a low-dose oxytocin infusion. Primary outcome was the rate of vaginal birth. Secondary outcomes were
Foley catheter versus cervical double balloon for labor induction: a prospective randomized study
The Journal of Maternal-Fetal & Neonatal Medicine, 2019
Objective: Cervical ripening by mechanical methods enhances labor induction success. We compared Cervical Ripening Double Balloon catheter (CRDB) to Foley catheter. Study design: This prospective blind study randomized 85 nulliparas and 95 multiparas to labor induction by either Foley catheter or CRDB. Primary outcomes were Bishop score increment, time from catheter withdrawal to delivery, and cesarean section rate. Results: In multiparas, mean Bishop score increment between pre-and post-catheter was significantly higher in the CRDB catheter than in the Foley group (4.4 ± 1.9 and 3.4 ± 2.0, respectively, p ¼ .02). Mean interval from catheter withdrawal to delivery was shorter in the CRDB catheter (14.6 ± 12.3 and 8.6 ± 5.4) than in the Foley catheter group (22.6 ± 27.2 and 13.9 ± 17.7), in both nulliparas and multiparas (p ¼ .05 and p ¼ .03, respectively). In nulliparas, no statistically significant differences were found in mean Bishop score increment between the two catheters, but cesarean section rate was higher in the Foley group than the CRDB group (46.5% and 20%, respectively, p ¼ .02). Conclusion: Bishop score increment by CRDB catheter is more effective than induction by Foley catheter in multiparas. CRDB catheter is associated with decreased time to delivery in both nulliparas and multiparas and a lower cesarean section rate in nulliparas. ClinicalTrials.gov Identifier: NCT00501033 ARTICLE HISTORY
BMJ Open, 2019
IntroductionPremature rupture of membranes (PROM) occurs at term in 8% of pregnancies. Several studies have demonstrated that the risk of chorioamnionitis and neonatal sepsis increases with duration of PROM. Decreasing the time interval between PROM and delivery is associated with lower rates of maternal infections. In case of an unfavourable cervix, the use of prostaglandin for cervical maturation demonstrates some advantages over oxytocin. The use of double balloon catheter in reduction of PROM duration has not been evaluated in the literature.Methods and analysisWe are conducting a prospective, monocentric, randomised clinical trial on pregnant women with an unfavourable cervix showing PROM at term (RUBAPRO).After 12–24 hours of PROM, women are randomly assigned to one group treated with a double balloon catheter for 12 hours, with oxytocin administered after 6 hours or to the control group treated with 24 hours of vaginal prostaglandin followed by oxytocin infusion alone. Patien...
Obstetrical & Gynecological Survey, 2010
Purpose To compare maternal and neonatal outcomes of two methods of labor induction in nulliparous women with unfavorable cervix. Methods A case-control study was performed on nulliparous women with a cervical Bishop score \ 6, who underwent induction of labor with either extra-amniotic Foley catheter (Foley catheter study group) or vaginal tablets of prostaglandin E 2 (PGE 2 control group). The control group was matched for gestational age and for the indication to induce labor. Results A total of 346 nulliparous women were included. Similar rates of cesarean delivery were found in the Foley catheter and the PGE 2 groups (25.4 vs. 24.2 %, respectively, p = 0.8), without differences in maternal or neonatal adverse outcomes. In the Foley catheter group, induction to delivery interval was shorter compared with the PGE 2 group (25.1 vs. 36.6 h, respectively, p \ 0.001), and more women delivered within 24 h (55.0 vs. 40.4 %, respectively, p = 0.01). Conclusion Induction of labor with Foley catheter in nulliparous women with unfavorable cervix is associated with shorter induction to delivery interval, but with similar rates of cesarean deliveries and adverse pregnancy outcomes, as compared with vaginal tablets of PGE 2 .
Journal of Perinatology, 2017
Objective There is a paucity of head-to-head randomized trials that compare single-and double-balloon catheters, and the results of the available data in terms of time from catheter insertion to delivery and delivery mode are mixed. This metaanalysis of randomized controlled trials compares the efficacy of single-and double-balloon catheters in women undergoing labor induction. Study design Searches were made in MEDLINE, EMBASE, PubMed, ClinicalTrials.gov, and the Cochrane Library from inception through June 2016. Peer-reviewed randomized and quasi-randomized trials that compared single-and doubleballoon catheters head-to-head for cervical ripening or labor induction were identified. Eligible study populations consisted of women with singleton pregnancies that had any indication for labor induction and were randomly assigned to undergo induction with a single-or a double-balloon catheter. The primary outcome was time from catheter insertion to delivery and delivery mode. The secondary outcomes were intrapartum fever or chorioamnionitis, woman's satisfaction, and neonatal Apgar score. Results Of the 520 records identified, five randomized trials (996 women; 491 with single-balloon and 505 with doubleballoon catheters) were considered eligible and included in the meta-analysis. Time from catheter insertion to delivery did not differ between the two types of catheter (p = 0.527; WMD −0.87; 95% CI: −3.55, 1.82). The incidence of cesarean delivery also did not differ (p = 0.844; RR 0.97; 95% CI: 0.69, 1.35). Delivery within 24 h, delivery mode, incidences of intrapartum fever or chorioamnionitis, and neonatal Apgar score <7 at 5 min did not differ between the two types of catheter as well. Women who were induced with the single-balloon catheter were more satisfied (p = 0.029; WMD 0.56; 95% CI: 0.06, 1.06). Conclusion Time from catheter insertion to delivery and delivery mode were comparable between the two types of catheter.