Double-balloon Catheter Group Research Articles

Double-vs single-balloon catheter for induction of labor: Systematic review and individual participant data meta-analysis.

Evidence comparing double-balloon vs single-balloon catheter for induction of labor is divided. We aim to compare the efficacy and safety of double-vs single-balloon catheters using individual participant data. A search of Ovid MEDLINE, Embase, Ovid Emcare, CINAHL Plus, Scopus, and clinicaltrials.gov was conducted for randomized controlled trials published from March 2019 until April 13, 2021. Earlier trials were identified from the Cochrane Review on Mechanical Methods for Induction of Labour. Randomized controlled trials that compared double-balloon with single-balloon catheters for induction of labor in singleton gestations were eligible. Participant-level data were sought from trial investigators and an individual participant data meta-analysis was performed. The primary outcomes were rates of vaginal birth achieved, a composite measure of adverse maternal outcomes and a composite measure of adverse perinatal outcomes. We used a two-stage random-effects model. Data were analyzed from the intention-to-treat perspective. Of the eight eligible randomized controlled trials, three shared individual-level data with a total of 689 participants, 344 women in the double-balloon catheter group and 345 women in the single-balloon catheter group. The difference in the rate of vaginal birth between double-balloon catheter and single-balloon catheter was not statistically significant (relative risk [RR] 0.93, 95% confidence interval [CI] 0.86-1.00, p = 0.050; I2 0%; moderate-certainty evidence). Both perinatal outcomes (RR 0.81, 95% CI 0.54-1.21, p = 0.691; I2 0%; moderate-certainty evidence) and maternal composite outcomes (RR 0.65, 95% CI 0.15-2.87, p = 0.571; I2 55.46%; low-certainty evidence) were not significantly different between the two groups. Single-balloon catheter is at least comparable to double-balloon catheter in terms of vaginal birth rate and maternal and perinatal safety outcomes.

Is there a difference in labor patterns after induction with prostaglandins and double-balloon catheters?

Labor progression curves are believed to differ between spontaneous and induced labors. However, data describing labor progression patterns with different modes of induction are insufficient. This study aimed to compare the progress patterns between labors induced with slow-release prostaglandin E2 vaginal analogue and those induced with a double-balloon catheter. This retrospective cohort study included all nulliparous women who delivered at term and who underwent cervical ripening with prostaglandin E2 vaginal analogue or a double-balloon catheter from 2013 to 2021 in a tertiary hospital in Israel. Included in the analysis were women who achieved 10 cm cervical dilatation. The time intervals between centimeter-to-centimeter changes were evaluated. A total of 1087 women were included of whom 786 (72.3%) were induced using prostaglandin E2 vaginal analogue and 301 (27.7%) were induced using a double-balloon catheter. The time from induction to birth was similar between the groups (32.5 hours for the prostaglandin E2 vaginal analogue group [5th-95th percentiles, 6.5-153.8] vs 29.2 hours for the double-balloon group [5th-95th percentiles, 9.1-157.1]; P=.100). The median time of the latent phase (2-6 cm dilation) was longer for the double-balloon catheter group than for the prostaglandin E2 vaginal analogue group (7.3 hours [5th-95th percentiles, 5.6-14.5] vs 6.0 hours [5th-95th percentiles, 2.4-18.8]; P=.042). The median time of active labor (6-10 cm dilatation) was similar between groups (1.9 hours [5th-95th percentiles, 0.3-7.4] for the prostaglandin E2 vaginal analogue group vs 2.3 hours [5th-95th percentiles, 0.3-6.5] for the double-balloon catheter group; P=.307). Deliveries subjected to cervical ripening with a double-balloon catheter were characterized by a slightly longer latent phase than deliveries induced by prostaglandin E2 vaginal analogue. After reaching the active phase of labor, the mode of cervical ripening did not influence the labor progress pattern.

Efficacy and safety of double balloon catheter and dinoprostone for labor induction in multipara at term

PurposeThe aim of this study was to comparatively assess the efficacy and safety of double balloon catheter (DBC) and dinoprostone as labor-inducing agents just for multipara at term.MethodsA retrospective cohort study was conducted among multipara at term with a Bishop score < 6 who needed planned labor induction from January 1, 2020, to December 30, 2020 in Maternal and Child Health Hospital of Hubei province, Tongji Medical College, Huazhong University of Science and Technology. They were divided into DBC group and dinoprostone group, respectively. Baseline maternal data, maternal and neonatal outcomes were recorded for statistical analysis. Total vaginal delivery rate, rate of vaginal delivery within 24 h, rate of uterine hyperstimulation combined with abnormal fetal heart rate(FHR) were regarded as the primary outcome variables. The difference between groups was considered statistically significant when p value < 0.05.ResultsA total of 202 multiparas was included for analysis (95 women in DBC group vs 107 women in dinoprostone group). There were no significant differences in total vaginal delivery rate and rate of vaginal delivery within 24 h between groups. Uterine hyperstimulation combined with abnormal FHR occurred exclusively in dinoprostone group.ConclusionDBC and dinoprostone seem to be equally effective, while, DBC seems to be safer than dinoprostone.

Comparing the effectiveness and safety of Dinoprostone vaginal insert and double-balloon catheter as cervical ripening treatments in Chinese patients.

BackgroundThis retrospective study was to compare the effectiveness and safety of Dinoprostone vaginal insert vs. double-balloon catheter as cervical ripening agents for labor induction.MethodsPregnant women with Bishop score <7, who received either Dinoprostone vaginal insert 10 mg or Cook's double-balloon catheter for labor induction, were studied. The primary outcome was the rate of vaginal delivery within 48 h; the secondary outcomes were the proportion of women undergoing cesarean section, labor duration, oxytocin administration, changes in Bishop score, complications during labor, and maternal/neonatal outcomes.ResultsOne hundred and eighty-two women were included in Dinoprostone group, and 199 women were in double-balloon catheter group. The rate of vaginal delivery within 48 h was significantly higher in Dinoprostone group than that in double-balloon catheter group (90.11% vs. 75.38%, P = 0.0002). There were 18 cesarean section deliveries (9.89%) in Dinoprostone group and 49 cesarean section deliveries (24.62%) in double-balloon catheter group, with significant differences between two groups (P = 0.0002). The duration of labor was higher in Dinoprostone group, while the augmentation with oxytocin was significantly lower in Dinoprostone group than in double-balloon catheter group (all P < 0.0001). The incidence of chorioamnionitis was significantly higher in double-balloon catheter group as compared with Dinoprostone group (0 vs. 12, P = 0.0005), while neonatal outcomes were similar in two groups.ConclusionDinoprostone vaginal insert as cervical ripening agent is more effective for labor induction and with lower risks of chorioamnionitis as compared with double balloon catheter in Chinese populations.

Balloon catheter vs oxytocin alone for induction of labor in women with one previous cesarean section and an unfavorable cervix: a multicenter, retrospective study.

To compare the rate of vaginal birth between double-balloon catheter and oxytocin alone for induction of labor in women with one previous cesarean section and an unfavorable cervix. A retrospective and observational study was conducted from 2013 to 2017, at the Saint-Etienne University Hospital where women received induction with a double-balloon catheter for 12h and at the Grenoble Alpes University Hospital where women received induction with a low-dose oxytocin infusion. Primary outcome was the rate of vaginal birth. Out of 1920 women eligible for attempting a vaginal birth after one previous cesarean section, 501 had a labor induction. Among women with an unfavorable cervix, 160 received a double-balloon catheter in Saint Etienne and 152 received oxytocin alone in Grenoble. The vaginal birth rate was higher in the double-balloon catheter group (61% versus 47% in the oxytocin group). An induction of labor with oxytocin alone reduced chances of vaginal birth (aOR 0.38 CI-95% [0.22-0.66]) compared to cervical ripening with double-balloon catheter. The perinatal morbidity was similar in the two groups. There was, however, 3.9% uterine rupture in the oxytocin group versus 0.6% in the double-balloon group (p = 0.11). For induction of labor in women with one previous cesarean section and with unfavorable cervix, cervical ripening with a double-balloon catheter increases the rate of vaginal birth without increased risk of uterine rupture.

Multicentre randomised controlled trial comparing the safety in the first 12h, efficacy and maternal satisfaction of a double balloon catheter and prostaglandin pessary for induction of labour.

To evaluate the safety in the first 12h, efficacy and maternal satisfaction of a double balloon catheter (DBC) with vaginal prostaglandin (PGE) for induction of labour (IOL). We conducted a multicentre randomised controlled study of 420 patients from 1st January 2016 to 31st December 2017 to evaluate the use of DBC in IOL in an Asian population looking at the adverse effects in the first 12h after insertion. Women were assigned randomly to cervical ripening with either a DBC or a prostaglandin pessary. The adverse events in the 12h after DBC or first prostaglandin inserted, the efficacy of a DBC to a prostaglandin in labour induction and maternal satisfaction were evaluated. There were significantly less women with uterine hyperstimulation in the DBC (2 vs 24, p ≤ 0.0001) compared to the prostaglandin group. There were no women with uterine hyperstimulation and non-reassuring foetal status in the DBC while there were 5 women with uterine hyperstimulation and foetal distress in the prostaglandin group. Use of entonox was significantly less in the DBC group (p = 0.009). There were no significant differences in both groups in caesarean section, vaginal deliveries and time to delivery, although significant less time was needed to achieve cervical os dilation more than 4cm in the DBC group (p ≤ 0.0001). Neonatal birth outcomes were similar. Women's pain scores were similar for both methods. 80.1% of women allocated the DBC and 76.8% of women allocated the PGE were keen to recommend their method of induction. Double balloon catheter remains a good alternative method for inducing women in view of a good safety profile with low risk of hyperstimulation and high maternal satisfaction. ClinicalTrials.gov Identifier: NCT02620215.

Induction of labour in mid-trimester pregnancy using double-balloon catheter placement within 12\u2009h versus within 12\u201324\u2009h

BackgroundThis study aims to evaluate the efficacy and safety of the induction of labour in mid-trimester pregnancy using a double-balloon catheter (DBC) within 12 h versus within 12–24 h.MethodsIn this retrospective study, a total of 58 pregnant women at 14 + 0 weeks to 27 + 6 weeks of gestation were enrolled as research subjects, and they underwent the intended termination of pregnancy at our birth centre from January 1, 2017, to June 31, 2019. Based on the duration of DBC, the patients were divided into two groups, namely, the DBC group within 12 h and the DBC group within 12–24 h.ResultsAll 58 cases were successful vaginal deliveries, and no one chose to undergo caesarean section. The success rate of induction (successful abortion of the foetus and placenta without the implementation of dilation and evacuation) was higher in the DBC group within 12–24 h (96.3%, 29/31) than in the DBC group within 12 h (71.0%, 18/27) (p < 0.05). Additionally, the time from DBC removal to delivery in the DBC group within 12–24 h was significantly shorter than that in the DBC group within 12 h (3.0 h versus 17.8 h) (p < 0.05), and the degree of cervical dilation after DBC removal in the DBC group within 12–24 h was larger than that in the DBC group within 12 h (p < 0.05).ConclusionIn the clinic, the placement time of DBC generally lasts for approximately 12 h. However, considering that the cervical condition is immature in the mid-trimester, properly extending the placement time of DBC to 24 h will benefit cervical ripening and reduce the chance of dilation and evacuation.

Double-balloon catheter versus prostaglandin for cervical ripening to induce labor after previous cesarean delivery.

To compare the effectiveness of cervical ripening by a mechanical method (double-balloon catheter) and a pharmacological method (prostaglandins) in women with one previous cesarean delivery, an unfavorable cervix (Bishop score < 6), and a singleton fetus in cephalic presentation. This retrospective study, reviewing the relevant records for the years 2013 through 2017, took place in two French university hospital maternity units. This study included women with one previous cesarean delivery, a liveborn singleton fetus in cephalic presentation, and intact membranes, for whom cervical ripening, with unfavorable cervix (Bishop score < 6) was indicated for medical reasons. It compared two groups: (1) women giving birth in a hospital that uses a protocol for mechanical cervical ripening by a double-balloon catheter (DBC), and (2) women giving birth in a hospital that performed pharmacological cervical ripening by prostaglandins. The principal endpoint was the cesarean delivery rate. The secondary outcome measures were maternal and neonatal outcomes. We compared 127 women with prostaglandin ripening to 117 women with DBC. There was no significant difference between the two groups for the cesarean rate (42.5% in the prostaglandin group and 42.7% in the DBC group; p = 0.973; crude OR 1.01 [0.61-1.68]; adjusted OR 1.55 [0.71-3.37]). The median interval between the start of ripening and delivery did not differ between the groups (28.7h in the prostaglandin group vs 25.6h in the DBC group; p = 0.880). Neonatal outcomes did not differ between the groups, either. There was one case of uterine rupture in the prostaglandin group, with no associated maternal or neonatal morbidity. There were no neonatal deaths. The postpartum hemorrhage rate was significantly higher in the DBC group. For cervical ripening for women with one previous cesarean, the choice of a pharmacological or mechanical protocol does not appear to modify the mode of delivery or maternal or neonatal morbidity.

Double-balloon catheter compared with single-balloon catheter for induction of labor with a scarred uterus

BackgroundIn obstetrics, labor induction is a common procedure. It has been proved that both single balloon catheters (Foley’s catheter) and double balloon catheters (Cook cervical ripening balloon) are effective and relatively safe in cervical ripening and labor induction. This research aimed to compare the efficacy of single and double balloon catheter in the induction of labor with scarred uterus. Methods120 pregnant women who had prior cesarean delivery participated in this research and were randomized into single-balloon catheter group (n = 60) and double-balloon catheter group (n = 60). The cervical ripening effect, security, and influence to the process of childbirth were analyzed in each group. ResultsThe validity of cervical ripening in single balloon group was better than double balloon group. Double balloon catheters increased the time between insertion and expulsion of the catheter and decreased spontaneous catheter expulsion rate. All the neonatal outcomes in these two groups were comparable. ConclusionBased on our data, the two different catheters both have their pros and cons in the labor induction of pregnant women with scarred uterus. The appropriate catheter used based on specific circumstance will improve the quality of labor induction.

Republication de : Méthodes de maturation cervicale et déclenchement du travail : évaluation de la sonde simple ballonnet comparée à la sonde double ballonnet et aux prostaglandines

ObjectiveTo compare the effectiveness of single balloon catheter with double balloon catheter and dinoprostone insert for cervical ripening and labor induction on unfavourable cervix. Methodsthis is a comparative, retrospective, one-center trial. Were included singleton pregnancy in cephalic presentation. Were excluded cicatricial uterus. The outcomes were vaginal delivery rate, caesarean section rate, modification in Bishop score, time from induction to delivery, second time prostaglandin E2 resort, oxytocin administration resort, maternal or neonatal adverse events. ResultsWere included 108 patients: 45 in single balloon catheter group, 32 in double balloon catheter group, 31 in dinoprostone insert group. Vaginal delivery rate was similar in single balloon catheter group (78 %) compared with others groups (75 % in double balloon catheter and 71 % in dinoprostone insert group respectively). Oxytocin administration resort was superior in single balloon catheter group. There was no significant difference on others outcomes. Labor induction costs were 9euros in single balloon catheter group, versus 55 and 81 euros in double balloon catheter group and dinoprostone insert group respectively. ConclusionsSingle balloon catheter seems just as effective as double balloon catheter and dinoprostone insert with its major asset the low cost for labor induction.

Efficiency of the Foley catheter versus the double balloon catheter during the induction of second trimester pregnancy terminations: a randomized controlled trial.

To compare induction-to-delivery intervals of Foley catheters and double balloon catheters in second trimester pregnancy terminations. This randomized parallel study was conducted on women who underwent second trimester terminations between December 2016 and December 2017. Pregnant women in the second trimester with a Bishop score < 6 were included in the study. Participants were randomized into two groups, the first being the Foley catheter group and the second being the double balloon catheter group. The time frames from insertion of catheters to the delivery were recorded in each group. A multiple regression analysis was carried out to examine the contribution of factors to the induction-to-delivery interval. A survival analysis was conducted to compare the Foley method and the double balloon method. A total of 91 pregnant women were included in the final analysis. The induction-to-delivery interval was shorter in the Foley catheter group than in the double balloon catheter group (38h 54min ± 21h 6min versus 58h 17min ± 25h 56min). We also found that women with intrauterine fetal death (IUFD) had a shorter time to delivery compared to women with live fetuses (39h 12min ± 18h 46min vs 51h 30min ± 26h 42min, p = 0.04). Women with a history of vaginal delivery also had a shorter induction-to-delivery time compared to women who never delivered vaginally before (38h 12min ± 17h 42min vs 53h 54min ± 27h 18min, p = 0.004). In the multiple regression analysis, the most significant contributor to the induction-to-delivery time was the method used for induction of labor and followed by other factors including the viability of the fetus (live/IUFD), history of vaginal delivery and PPROM. The survival analysis showed that the induction-to-delivery interval was significantly shorter in the Foley catheter group than in the double balloon catheter group (HR 2.51, 95% CI 1.57-4.00, p = 0.001). During the termination of second trimester pregnancies time from induction of labor to delivery is shorter with the Foley catheter compared to double balloon catheter.

Méthodes de maturation cervicale et déclenchement du travail : évaluation de la sonde simple ballonnet comparée à la sonde double ballonnet et aux prostaglandines

ObjectiveTo compare the effectiveness of single balloon catheter with double balloon catheter and dinoprostone insert for cervical ripening and labor induction on unfavourable cervix. Methodsthis is a comparative, retrospective, one-center trial. Were included singleton pregnancy in cephalic presentation. Were excluded cicatricial uterus. The outcomes were vaginal delivery rate, caesarean section rate, modification in Bishop score, time from induction to delivery, second time prostaglandin E2 resort, oxytocin administration resort, maternal or neonatal adverse events. ResultsWere included 108 patients: 45 in single balloon catheter group, 32 in double balloon catheter group, 31 in dinoprostone insert group. Vaginal delivery rate was similar in single balloon catheter group (78 %) compared with others groups (75 % in double balloon catheter and 71 % in dinoprostone insert group respectively). Oxytocin administration resort was superior in single balloon catheter group. There was no significant difference on others outcomes. Labor induction costs were 9euros in single balloon catheter group, versus 55 and 81 euros in double balloon catheter group and dinoprostone insert group respectively. ConclusionsSingle balloon catheter seems just as effective as double balloon catheter and dinoprostone insert with its major asset the low cost for labor induction.

Double-balloon catheter and sequential oral misoprostol versus oral misoprostol alone for induction of labour at term: a retrospective cohort study

ObjectiveTo evaluate the efficacy of induction of labour using a double-balloon catheter and, if necessary, sequential oral misoprostol without delay after removal of the catheter, in comparison with oral misoprostol alone. Study designThis retrospective cohort study included women undergoing induction of labour with oral misoprostol or double-balloon catheter with sequential oral misoprostol in singleton pregnancies at term. The catheter was placed in the evening and removed when there was no onset of labour within 12h. Then oral misoprostol was started within 3h. Primary outcome measure was the caesarean section rate. ResultsThere were 13,082 deliveries during the study period with 3466 labour inductions out of which 1032 were eligible and analysed. The caesarean section rate was significantly lower in the double-balloon catheter group (26.1% vs. 17.3, p=0.021). Furthermore, in the combination group, the induction-to-delivery interval was shorter (median values 1144 vs. 1365min, p=0.001) and there were more deliveries within 24h (51.9 vs. 64.7%, p=0.003) and 48h (87.4 vs. 95.8%, p=0.002). When stratifying for parity, there were less caesarean sections in the combination group (37.2% vs. 24.2%, p=0.015) in nulliparous women, too. In both, nulliparous and parous women, the induction-to-delivery interval was shorter (1742 vs. 1400min, 0.005; 1020 vs. 912min, p=0.018). Especially in parous women, the rates of delivery within 24h (62.6% vs. 79.0%, p=0.007) and 48h (88.6% vs. 99.0%, p=0.007) were higher in the combination group. ConclusionDouble-balloon catheter and sequential oral misoprostol without long delay in absent onset of labour after removal of the catheter resulted in less caesarean section and shorter induction-to-delivery interval in comparison with oral misoprostol alone.

Single-Balloon Compared With Double-Balloon Catheters for Induction of Labor

To estimate the efficacy of a single-balloon catheter compared with a double-balloon catheter among women with unfavorable cervices undergoing induction of labor. 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. 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=.80). 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=.09). The incidence of either vacuum deliveries or cesarean deliveries was significantly lower among the single-balloon group (14.4%) compared with the double-balloon catheter group (25.7%; odds ratio 0.49, 95% confidence interval 0.26-0.92; P=.02). 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.

Induction of Labor in Nulliparous Women With an Unfavorable Cervix: A Randomized Controlled Trial Comparing Double and Single Balloon Catheters and PGE2 Gel

There is no consensus on the optimal technique to achieve cervical ripening in nulliparous women before attempting labor induction. Common cervical ripening methods include a synthetic prostaglandin (PGE2) gel, a single balloon (Foley) catheter, or a double balloon catheter. Studies investigating these techniques have been limited by differences in patient population, design deficiencies, and inconclusive results. This randomized controlled trial compared these 3 induction methods for efficacy, safety, and the level of patient satisfaction in 330 term nulliparous women with unfavorable cervices. The study subjects were randomized to receive either a double balloon catheter (n = 107), single balloon (Foley) catheter (n = 110), or a PGE2 gel (n = 113). No difference was found in rates of cesarean delivery between the groups (double balloon 43%, single balloon 36%, and PGE2 37%, P = 0.567). The time from induction to delivery was longer in the double balloon group (median: 24.5 hours, 95% confidence interval: 23.7-30.6 hours) compared to single balloon (23.2, 20.8-25.8 hours) or PGE2 (23.8, 21.7-26.8 hours, P = 0.043). Use of the PGE2 gel for cervical ripening was associated with uterine hyperstimulation (14%), with none occurring in the other 2 groups. No adverse reactions occurred in the group receiving the single balloon catheter. Significantly more adverse reactions were noted in the PGE2 group (17 events) than in the double balloon catheter group (5 events; P < 0.001). The PGE2 group also had a lower median arterial pH: 7.25 (range: 6.91-7.41) in the PGE2 group, 7.26 (range: 7.03-7.40) in the double balloon group, and 7.26 (7.05-7.44) in the single balloon group (P = 0.050). Significantly less pain was reported by the women in the single balloon group during the cervical ripening phase: 36% had a pain score ≥4 in the single balloon group compared with 55% in the double balloon group and 63% in the PGE2 group (P < 0.001). The median overall satisfaction scores were the same in all 3 groups (8/10). These findings show that term women with unfavorable cervices have high cesarean delivery rates that are not affected by the method of induction. Although the efficacy of the induction techniques is similar, the data suggest to the investigators that a single balloon catheter is the safest and most acceptable method of cervical ripening.