Patient satisfaction with the cervical ripening balloon as a method for induction of labour: a randomised controlled trial (original) (raw)
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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.
Obstetrics & Gynecology International Journal
Aim: To compare effectiveness and safety of double balloon catheter and prostaglandins for induction of labor. Methods: an observational ambidirectional cohort study was conducted at a tertiary care university hospital. A total of 666 women with a Bishop score ≤6 requiring labor induction were included. A cohort of 418 patients with double balloon catheter were compared with a retrospective cohort of 248 women induced with prostaglandins, either misoprostol or dinoprostone. Perinatal outcomes were compared between groups, with a p<0.05 considered statistically significant. Results: The cesarean-section rate was 27% in the double balloon group, compared with 27.8% in the prostaglandin group (p=0.352). The mean induction time-to-delivery was longer in the double balloon group as compared to the prostaglandin group (26.6±9.3 hrs vs 19.1±8.6 hrs, p<0.001). Hyperdynamia and umbilical-cord arterial pH<7.1 rates were significantly lower with the mechanical method compared to prost...
Outpatient Induction of Labor – Are Balloon Catheters an Appropriate Method?
Geburtshilfe und Frauenheilkunde, 2021
As the number of labor inductions in high-income countries has steadily risen, hospital costs and the additional burden on obstetric staff have also increased. Outpatient induction of labor is therefore becoming increasingly important. It has been estimated that 20 – 50% of all pregnant women requiring induction would be eligible for outpatient induction. The use of balloon catheters in patients with an unripe cervix has been shown to be an effective and safe method of cervical priming. Balloon catheters are as effective as the vaginal administration of prostaglandin E2 or oral misoprostol. The advantage of using a balloon catheter is that it avoids uterine hyperstimulation and monitoring is less expensive. This makes balloon catheters a suitable option for outpatient cervical ripening. Admittedly, intravenous administration of oxytocin to induce or augment labor is required in approximately 75% of cases. Balloon catheters are not associated with a higher risk of maternal and neonat...
BackgroundThe aim was to assess the feasibility of conducting a randomised controlled trial (RCT) of induction of labour comparing use of two methods in the out-patient setting.MethodsAn open-label feasibility RCT was conducted in two UK maternity units from October 2017 to March 2019. Women aged ≥16 years, undergoing Induction of labour (IoL) at term, with intact membranes and deemed suitable for out-patient IoL according to local guidelines were considered eligible. They were randomised to cervical ripening balloon catheter (CRB) or vaginal Dinoprostone (Propess). The participants completed a questionnaire and a sub-group underwent detailed interview. Health economics data were collected. Women who declined to participate were also requested to complete a decliners’ questionnaire.ResultsDuring the study period 274 eligible women were identified. 230 (83.9%) were approached for participation of whom 84 (36.5%) agreed. Of these, 38 were randomised to Propess (n=20) and CRB (n=18). T...
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
Archives of Gynecology and Obstetrics, 2018
Purpose To analyze the effect of combined application of intravaginal PGE2 insert and intracervical Foley balloon catheter for induction of labor. Methods Patients with unfavorable cervices who required induction of labor from August 2017 to December 2017 were evaluated for the study. Three hundred and ten participants were randomly assigned to study (n:155) and control group (n:155). Nine patients in study group and seven patients in control group were excluded, because they declined to participate in the study. Totally, 294 women analyzed in this prospective randomized study: Group 1 (control group): labor induction with intravaginal PgE2 vaginal insert alone (n = 148) and Group 2 (study group): intracervical Foley balloon catheter insertion adjunct to the intravaginal PgE2 insert (n = 146). The primary outcome of our study was the period from induction to delivery. The secondary outcome was the period from induction to active phase of labor. Results In the analysis of primiparous pregnants, combination of intracervical Foley balloon catheter and intravaginal PgE2 insertion was shown to be associated with shorter duration from induction to active stage of labor (1000 vs. 585 min, P < 0.001) and also to delivery (1386 vs. 1001 min, P < 0.001). Groups were found to be similar in terms of duration from induction to active stage of labor (670.5 vs. 535.2, P > 0.05) and also to delivery (933.1 vs. 777.9, P > 0.05, Table 2) in subgroup of women with the previous vaginal delivery. Conclusions Combined application of intracervical Foley balloon catheter and intravaginal PgE2 insert may result in a shorter time from labor induction to delivery without rising the risk of cesarean section in primiparous women with an unfavorable cervix.
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.
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.