Outpatient Induction of Labor – Are Balloon Catheters an Appropriate Method? (original) (raw)
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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
Singapore medical journal, 2018
Evidence has shown that balloon catheters are as effective as prostaglandins (PGE) in achieving vaginal delivery within 24 hours of the start of induction of labour (IOL), with lower rates of uterine hyperstimulation, and similar Caesarean section and infection rates. International guidelines recommend mechanical methods as a method of IOL. We designed a prospective randomised controlled study to evaluate patient acceptance of the cervical ripening balloon (CRB) for IOL. Suitable women with a singleton term pregnancy without major fetal anomaly suitable for vaginal delivery were recruited and randomised to receive the CRB or PGE on the day of IOL. Characteristics of the women, labour and birth outcomes were obtained from case notes. Pain and satisfaction scores were obtained by interviewing the women at IOL and after delivery. The main outcome measures were participant characteristics, labour and birth outcomes, pain score, satisfaction scores, and whether the participant would reco...
BJOG: An International Journal of Obstetrics & Gynaecology, 2009
Objective To compare the efficacy and patient satisfaction of three methods of labour induction (double balloon catheters, single balloon catheters and prostaglandin gel) in term nulliparous women with unfavourable cervices. Design Randomised controlled trial. Population A total of 330 nulliparous women with unfavourable cervices induced at term. Methods Three cervical ripening study arms were used: double balloon catheter (107 women); 16F Foley catheter (110 women) and PGE 2 gel (2 mg) (113 women). Main outcome measures Caesarean section, induction to delivery interval, adverse reactions and patient satisfaction. Results There was no difference in caesarean delivery rates between groups (double balloon 43%, single balloon 36%, PGE 2 37%, P = 0.567). The induction to delivery interval was longer in the double balloon group (median 24.5; 95% CI 23.7, 30.6 hours) than the single balloon (23.2; 20.8, 25.8 hours) or PGE 2 (23.8; 21.7, 26.8 hours) (P = 0.043). Uterine hyperstimulation occurred in 14% of the PGE 2 group with none occurring with mechanical cervical ripening. Cord blood gases were worse in the PGE 2 group: median arterial pH double balloon 7.26 (range 7.03-7.40); single balloon 7.26 (7.05-7.44); PGE 2 7.25 (6.91-7.41) (P = 0.050). Cervical ripening with the single balloon catheter was associated with significantly less pain (pain score ‡4: double balloon 55%, single balloon 36%, PGE 2 63%, P < 0.001). Conclusions Labour induction in nullipara with unfavourable cervices results in high caesarean delivery rates. Although all methods in this study had similar efficacy, the single balloon catheter offers the best combination of safety and patient comfort.
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.
American Journal of Obstetrics and Gynecology, 2010
We performed a metaanalysis of publications comparing the efficacy and safety of cervical ripening and labor induction by Foley catheter balloon (FCB) vs locally applied prostaglandins (LAPG) in the third trimester of pregnancy. Twenty-seven randomized controlled trials (1966-2008; 3532 participants) were selected from MEDLINE, EMBASE, and CENTRAL searches. There was no significant difference between FCB and LAPG in cesarean delivery rates. LAPG had a significantly increased risk of excessive uterine activity (P ϭ .001). FCB had a significantly higher risk of oxytocin induction/augmentation during labor (P ϭ .0002). Cervical prostaglandin-E2 was less effective (P ϭ .04), and vaginal prostaglandin-E1 bore a significantly higher risk of excessive uterine activity (P Ͻ .0001) and meconium staining (P ϭ .04). We concluded that FCB and LAPG result in similar cesarean delivery rates, that FCB bears a higher risk of oxytocin use for labor induction and/or augmentation, and that LAPG carries a higher risk of contraction abnormalities.
Induction of cervical compliance by balloon catheter in late pregnancy
International Journal of Gynecology & Obstetrics, 1983
Balloon catheter was used for pre-induction cervical priming and in order to enhance induction of labor in 51 patients. This procedure was found to be a safe and effective adjunct to induction of labor in patients with unripe cervices (mean Bishop score 3.4) with induction of labor to delivery time of 6.5 h.
Journal of the Turkish-German Gynecological Association, 2018
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.
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.