Methods for the induction of labor: efficacy and safety.

This review assessed the efficacy and safety of pharmacologic agents (prostaglandins, oxytocin, mifepristone, hyaluronidase, and nitric oxide donors) and mechanical methods (single- and double-balloon catheters, laminaria, membrane stripping, and amniotomy) and those generally considered under the rubric of complementary medicine (castor oil, nipple stimulation, sexual intercourse, herbal medicine, and acupuncture). A substantial body of published reports, including 2 large network meta-analyses, support the safety and efficacy of misoprostol (PGE1) when used for cervical ripening and labor induction. Misoprostol administered vaginally at doses of 50 µg has the highest probability of achieving vaginal delivery within 24 hours. Regardless of dosing, route, and schedule of administration, when used for cervical ripening and labor induction, prostaglandin E2 seems to have similar efficacy in decreasing cesarean delivery rates. Globally, although oxytocin represents the most widely used pharmacologic agent for labor induction, its effectiveness is highly dependent on parity and cervical status. Oxytocin is more effective than expectant management in inducing labor, and the efficacy of oxytocin is enhanced when combined with amniotomy. However, prostaglandins administered vaginally or intracervically are more effective in inducing labor than oxytocin. A single 200-mg oral tablet of mifepristone seems to represent the lowest effective dose for cervical ripening. The bulk of the literature assessing relaxin suggests this agent has limited benefit when used for this indication. Although intracervical injection of hyaluronidase may cause cervical ripening, the need for intracervical administration has limited the use of this agent. Concerning the vaginal administration of nitric oxide donors, including isosorbide mononitrate, isosorbide, nitroglycerin, and sodium nitroprusside, the higher incidence of side effects with these agents has limited their use. A synthetic hygroscopic cervical dilator has been found to be effective for preinduction cervical ripening. Although a pharmacologic agent may be administered after the use of the synthetic hygroscopic dilator, in an attempt to reduce the interval to vaginal delivery, concomitant use of mechanical and pharmacologic methods is being explored. Combining the use of a single-balloon catheter with dinoprostone, misoprostol, or oxytocin enhances the efficacy of these pharmacologic agents in cervical ripening and labor induction. The efficacy of single- and double-balloon catheters in cervical ripening and labor induction seems similar. To date, the combination of misoprostol with an intracervical catheter seems to be the best approach when balancing delivery times with safety. Although complementary methods are occasionally used by patients, given the lack of data documenting their efficacy and safety, these methods are rarely used in hospital settings.

Preinduction cervical ripening in an outpatient setting: a prospective pilot study of a synthetic osmotic dilator compared with a double-balloon catheter.

OBJECTIVES: To compare the effectiveness, safety and patient satisfaction of a double balloon catheter (DB) with a synthetic osmotic cervical dilator (OD) for pre-induction cervical ripening in an outpatient setting. METHODS: This is a prospective, dual-center pilot study including 94 patients with an unripe cervix (Bishop Score <6) near term; 50 patients received the DB and 44 patients the OD. The primary outcomes were the difference in Bishop Score (BS) and cervical shortening. Pain perception at insertion and during the cervical ripening period was evaluated by a visual analogue scale and patient satisfaction by a predefined questionnaire. RESULTS: The use of DB was associated with a significantly higher increase in BS (median 3) compared to OD (median 2; p=0.002) and resulted in significantly greater cervical shortening (median -14 mm vs. -9 mm; p=0.003). There were no serious adverse events at placement of devices or during the cervical ripening. There were no significant differences in perinatal outcomes. Pain perception during cervical ripening was significantly higher (p<0.001), and patient satisfaction regarding sleep, relaxing time and performing desired daily activities were significantly lower in patients with DB compared to patients with OD (p<0.001). CONCLUSIONS: DB was superior to OD regarding cervical ripening based on BS and on sonographic measurement of the cervical length. Patients with OD experienced less pain during cervical ripening and were more satisfied with the method compared to patients with DB.

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

PURPOSE: The 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. METHODS: A 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. RESULTS: A 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. CONCLUSION: DBC and dinoprostone seem to be equally effective, while, DBC seems to be safer than dinoprostone.

Double-balloon catheter vs dinoprostone (PGE-2) insert for labour induction: A meta-analysis of 2493 pregnancies.

Induction of labor (IOL) is the stimulation of the uterus during pregnancy to begin the onset of labour. Nearly two of five pregnancies require IOL. We compared the effectiveness of double-balloon catheter (DBC) with dinoprostone (PGE-2) insert for labour induction from previous studies. We included randomized controlled trials (RCTs) that compared the safety and efficacy of DBC to PGE-2. To evaluate the studies, we utilized the Cochrane tool for risk of bias assessment. The rates of vaginal birth and cesarean section were the primary outcomes. We included ten RCTs in this meta-analysis with a total sample of 2493 singleton pregnancies. After 24 hours, there was no significant difference in the delivery rates between DBC and PGE-2 s [R.R=1.08, 95% CI, (0.77, 1.52), P.value=0.65], and the rate of cesarean delivery [R.R=1.03, 95% CI, (0.90; 1.18), P.value=0.65]. The DBC showed a significantly higher oxytocin use rate compared to the PGE-2 group [R.R=1.77, 95% CI, (1.41; 2.32), P.value<0.0001]. In the PGE-2 group, there was a significantly higher risk of uterine hyperstimulation, tachysystole, and umbilical artery PH levels below 7. There was no significant difference in the efficacy between the PGE-2 and DBC in terms of delivery rate in 24 hours and the rate of cesarean delivery except for a slight BISHOP score improvement with DBC. However, DBC showed a higher rate of oxytocin use compared to the PGE-2, the DBC seems to be safer with a lower risk of umbilical artery PH < 7, uterine hyperstimulation, and tachysystole incidence than PGE-2.

Safety and efficacy of double-balloon catheter for cervical ripening: a Bayesian network meta-analysis of randomized controlled trials.

BACKGROUND: Various methods are used for cervical ripening during the induction of labor. Mechanical and pharmacological methods are commonly used for cervical ripening. A double-balloon catheter was specifically developed to ripen the cervix and induce labor; however, the efficacy of the double-balloon catheter in cervical ripening compared to other methods is unknown. METHODS: We searched five databases and performed a Bayesian network meta-analysis. Six interventions (double-balloon catheter, Foley catheter, oral misoprostol, vaginal misoprostol, dinoprostone, and double-balloon catheter combined with oral misoprostol) were included in the search. The primary outcomes were cesarean delivery rate and time from intervention-to-birth. The secondary outcomes were as follows: Bishop score increment; achieving a vaginal delivery within 24 h; uterine hyperstimulation with fetal heart rate changes; need for oxytocin augmentation; instrumental delivery; meconium staining; chorioamnionitis; postpartum hemorrhage; low Apgar score; neonatal intensive care unit admission; and arterial pH. RESULTS: Forty-eight randomized controlled trials involving 11,482 pregnant women were identified. The cesarean delivery rates of the cervical ripening with a double-balloon catheter and oral misoprostol, oral misoprostol, and vaginal misoprostol were significantly lower than cervical ripening with a Foley catheter (OR = 0.48, 95% CI: 0.23-0.96; OR = 0.74, 95% CI: 0.58-0.93; and OR = 0.79, 95% CI: 0.64-0.97, respectively; all P < 0.05). The time from intervention-to-birth of vaginal misoprostol was significantly shorter than the other five cervical ripening methods. Vaginal misoprostol and oral misoprostol increased the risk of uterine hyperstimulation with fetal heart rate changes compared to a Foley catheter. A double-balloon catheter with or without oral misoprostol had similar outcomes, including uterine hyperstimulation with fetal heart rate changes compared to a Foley catheter. CONCLUSION: Double-balloon catheter did not show superiority when compared with other single method in primary and secondary outcomes of labor induction. The combination of double-balloon catheter with oral misoprostol was significantly reduced the rate of cesarean section compared to Foley catheter without increased risk of uterine hyperstimulation with fetal heart rate changes, which was shown in oral or vaginal misoprostol.

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

OBJECTIVE: To evaluate the safety in the first 12 h, efficacy and maternal satisfaction of a double balloon catheter (DBC) with vaginal prostaglandin (PGE) for induction of labour (IOL). METHODS: 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 12 h after insertion. Women were assigned randomly to cervical ripening with either a DBC or a prostaglandin pessary. The adverse events in the 12 h after DBC or first prostaglandin inserted, the efficacy of a DBC to a prostaglandin in labour induction and maternal satisfaction were evaluated. RESULTS: 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 4 cm 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. CONCLUSION: 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. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02620215.

Induction of labour in mid-trimester pregnancy using double-balloon catheter placement within 12 h versus within 12-24 h.

BACKGROUND: This 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. METHODS: In 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. RESULTS: All 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). CONCLUSION: In 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.

PURPOSE: 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. METHODS: 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. RESULTS: 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 (28.7 h in the prostaglandin group vs 25.6 h 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. CONCLUSION: 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 versus dinoprostone insert for labour induction: a meta-analysis.

OBJECTIVE: To assess the efficacy and safety of a double-balloon catheter versus dinoprostone insert for labour induction. STUDY DESIGN: PubMed, MEDLINE, Embase, ClinicalTrials.gov, and the Cochrane Central Register of Clinical Trials databases were searched from 1985 to April 2018. Randomized controlled trials that compared a double-balloon catheter and dinoprostone insert for cervical ripening were identified. Eligible study populations consisted of women with singleton pregnancies that had any indication for labour induction and were randomly assigned to undergo induction with a double-balloon catheter or dinoprostone insert. The main outcomes were incidence of vaginal delivery within 24 h and caesarean section, and neonatal outcomes. RESULTS: Five randomized trials (603 women; 305 with a double-balloon catheter and 298 with a dinoprostone insert) were eligible for inclusion. No differences were observed between the two groups in terms of vaginal delivery within 24 h [relative risk (RR) 1.21, 95% confidence interval (CI) 0.93-1.59] and incidence of caesarean section (RR 0.99, 95% CI 0.77-1.27). Compared with the double-balloon catheter, the dinoprostone insert was associated with a reduced need for oxytocin administration in the process of labour induction (RR 1.95, 95% CI 1.45-2.62). However, there was a higher incidence of excessive uterine activity (RR 0.17, 95% CI 0.06-0.54) and neonatal umbilical cord arterial blood pH < 7.1 (RR 0.36, 95% CI 0.15-0.84) in the dinoprostone insert group. CONCLUSION: This review showed that the efficacy of labour induction using both the double-balloon catheter and dinoprostone insert was similar. However, the double-balloon catheter seemed to be a safer method.

Single versus double-balloon catheters for the induction of labor of singleton pregnancies: a meta-analysis of randomized and quasi-randomized controlled trials.

OBJECTIVE: To compare the efficacy of single- versus double-balloon catheter (SBC vs. DBC) for cervical ripening and labor induction with an unfavorable cervix. METHODS: Systematic review and meta-analysis of randomized controlled trials (RCTs) or quasi-RCTs (qRCT) regarding the use of SBC or DBC for labor induction of live singleton cephalic pregnancies (≥ 35 weeks) of any parity with an unripe cervix (Bishop score ≤ 6). Nine research databases were searched for original articles published in all languages up to November 2017 comparing both devices for labor induction. Five RCTs and one qRCT were included. Primary outcome measures were time from intervention (device placement) to birth time, vaginal delivery and cesarean section rates, and maternal satisfaction with the procedure. Risk of bias was evaluated with the Cochrane tool. Random effects models were used to combine data for meta-analyses. Summary measures were reported as mean differences and risk ratios (RR) with 95% confidence intervals. RESULTS: Regardless of parity, pooled analyses of the six trials (n = 1060 women) found that mean intervention to birth time, vaginal delivery and cesarean section rates, and maternal satisfaction to the procedure were similar for both studied groups (SBC vs. DBC). CONCLUSION: Measured primary outcome measures were similar regardless of the type of device used for labor induction of singleton pregnancies.

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

PURPOSE: To compare induction-to-delivery intervals of Foley catheters and double balloon catheters in second trimester pregnancy terminations. METHODS: 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. RESULTS: 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 (38 h 54 min ± 21 h 6 min versus 58 h 17 min ± 25 h 56 min). We also found that women with intrauterine fetal death (IUFD) had a shorter time to delivery compared to women with live fetuses (39 h 12 min ± 18 h 46 min vs 51 h 30 min ± 26 h 42 min, 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 (38 h 12 min ± 17 h 42 min vs 53 h 54 min ± 27 h 18 min, 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). CONCLUSION: 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.

[Contrast study of double-balloon catheter with and without oxytocin for cervical ripening].

Objective: To evaluate the efficacy and related issues for cervical ripening by double-balloon catheter with and without oxytocin. Methods: The prospective non-randomly control research was conducted from March 2015 to June 2017 in Yuquan Hospital of Tsinghua University. The primipara with induced labor indications and balloon placement conditions were divided into two groups. Seventy-eight cases were in the balloon with oxytocin group, in which oxytocin was used if there were no contraction 1 hour after balloon placement. Meanwhile, 220 cases were in the single balloon group. Before and after balloon placement, the changes of cervical Bishop Scores and delivery outcome were compared between the groups. Results: The effective rate of cervical ripening in the balloon with oxytocin group was higher than that in the balloon group[92.3% (72/78) vs 82.7% (182/220), P<0.05], the proportion of parturiency within 12 hours was as well[15.4% (12/78) vs 7.3% (16/220), P<0.05]. The effective rate of cervical Bishop score 4-5 points was further improved in the balloon with oxytocin group[95.7%(66/69) vs 85.1% (165/194), P<0.05]. Taken out balloon, the cervical Bishop scores (8.1±1.1) points in the balloon with oxytocin group were higher than (6.5±1.2) points in the balloon group (P<0.05). For the maternal without parturiency in the balloon with oxytocin group, the cervical Bishop score reduced from (7.7±0.9) points to (6.6±0.6) points after removal balloon for 12 hours (P<0.05). The cesarean section proportion for intrauterine infection in the balloon with oxytocin group was higher than that of the balloon group ( P<0.05), but the placental pathological diagnosis proportion was no significant difference ( P>0.05). In the two groups, the cesarean section rate, the first labor stage, the episiotomy rate, the postpartum hemorrhage rate, neonatal weight, the neonatal asphyxia and referral rate showed no significant differences (P>0.05, respectively). Conclusions: The double-balloon catheter with oxytocin can further improve the efficiency of patients with cervical Bishop score 4-5 points for cervical ripening , and increase the chance of labor in 12 hours.

Double-balloon catheter versus prostaglandin E2 for cervical ripening and labour induction: a systematic review and meta-analysis of randomised controlled trials.

BACKGROUND: Induction of labour has become an increasingly common procedure. Ripening methods, including mechanical devices and pharmacological agents, improve the success rate of labour induction. OBJECTIVE: To compare the efficacy and safety of the double-balloon catheter with prostaglandin E2 agents used for labour induction. SEARCH STRATEGY: We searched electronic sources from MEDLINE, Embase and Web of Science, the Cochrane Library Database of Systematic Reviews, and ClinicalTrials.gov website. SELECTION CRITERIA: Only randomised controlled trials comparing the PGE2 agents with the double-balloon catheter for cervical ripening and labour induction in women with unfavourable cervices were included in the analysis. DATA COLLECTION AND ANALYSIS: The main outcomes included the vaginal delivery rate within 24 hours and risk of caesarean section. We calculated relative risks and mean differences using fixed- and random-effects models. MAIN RESULTS: Nine studies (1866 patients) were included in this systematic review. Both the double-balloon catheter and PGE2 agents were comparable with regard to rate of caesarean section (RR 0.92; 95% CI 0.79, 1.07), vaginal delivery within 24 hours (RR 0.95; 95% CI 0.78, 1.16) and maternal adverse events, but the risk of excessive uterine activity (RR 10.02; 95% CI 3.99, 25.17) and need for neonatal intensive care unit admissions (RR 1.31; 95% CI 1.01, 1.69) were significantly increased in women who received PGE2 agents. CONCLUSIONS: The double-balloon catheter demonstrated greater safety and cost-effectiveness than PGE2 agents for cervical ripening and labour induction. The efficacy profiles of both methods were similar. TWEETABLE ABSTRACT: Double-balloon catheter versus prostaglandin E2 for cervical ripening and labour induction.

Double-balloon catheter and sequential vaginal prostaglandin E2 versus vaginal prostaglandin E2 alone for induction of labor after previous cesarean section.

PURPOSE: To evaluate the efficacy of inducing labor using a double-balloon catheter and vaginal prostaglandin E2 (PGE2) sequentially, in comparison with vaginal PGE2 alone after previous cesarean section. METHODS: A total of 264 pregnant women with previous cesarean section undergoing labor induction at term were included in this prospective multicentre cohort study. Induction of labor was performed either by vaginal PGE2 gel or double-balloon catheter followed by vaginal PGE2. The primary outcome measure was the cesarean section rate. RESULTS: The cesarean section rate was 37 % without any statistically significant difference between the two groups (PGE2: n = 41, 37 % vs. balloon catheter/PGE2: n = 41, 42 %; P = 0.438). The median (range) number of applications of PGE2 [2 (1-10) versus 1 (0-8), P < 0.001] and the total amount of PGE2 used in median (range) mg [2 (1-15) vs. 1 (0-14), P = 0.001] was less in the balloon catheter/PGE2 group. Factors significantly increasing risk for cesarean section were "no previous vaginal delivery" (OR 5.391; CI 2.671-10.882) and "no oxytocin augmentation during childbirth" (OR 2.119; CI 1.215-3.695). CONCLUSIONS: The sequential application of double-balloon catheter and vaginal PGE2 is as effective as the sole use of vaginal PGE2 with less applications and total amount of PGE2.

Sequential use of double-balloon catheter and oral misoprostol versus oral misoprostol alone for induction of labour at term (CRBplus trial): a multicentre, open-label randomised controlled trial.

OBJECTIVE: To evaluate the efficacy of inducing labour using a double-balloon catheter and oral misoprostol sequentially, in comparison with oral misoprostol alone. DESIGN: A multicentre randomised controlled trial. SETTING: Five hospitals in Germany. POPULATION: A total of 326 pregnant women with an unfavourable cervix undergoing labour induction at term. METHODS: Women were randomly assigned according to a computer-generated allocation sequence to sequential use of double-balloon catheter and oral misoprostol (study group) or oral misoprostol alone (control group). In the study group, the double-balloon catheter was used the first day before starting oral misoprostol the second day. MAIN OUTCOME MEASURES: The primary outcome measure was the induction-to-delivery interval, and a further outcome parameter was delivery within 48 hours. RESULTS: The median times for induction of labour until delivery were 32.4 hours in the study group and 22.5 hours in the control group (P = 0.004). This difference was not seen when evaluating according to parity (nulliparous, P = 0.19; parous, P = 0.06). The rate of vaginal delivery within 48 hours did not differ between both groups. The number of applications of misoprostol (two versus three, P < 0.001) and the dose of misoprostol used was lower in the study group (100 versus 200 µg, P < 0.001). In the study group, there were more Apgar scores of <7 at 5 minutes (8 versus 1, P = 0.04). CONCLUSIONS: The use of a double-balloon catheter on the first day, before starting oral misoprostol on the second day, did not improve the induction to delivery interval and the rate of delivery within 48 hours, in comparison with oral misoprostol alone.

Prospective multi-centre randomised trial comparing induction of labour with a double-balloon catheter versus dinoprostone.

This randomised controlled study compared the efficacy of double-balloon catheter versus vaginal prostaglandin E2 (dinoprostone) for induction of labour. In total, 825 pregnant women with cephalic presentation and an unfavourable cervix undergoing induction for conventional indications were randomised to double-balloon or vaginal dinoprostone (3 mg) groups. There was a significantly higher failure rate for labour induction in the balloon group (relative risk: 1.25, 95% confidence interval [CI]: 1.02-1.49). Median induction time was 27.3 h in the balloon group and 29.8 h in the dinoprostone group (difference not significant). After 24 h, 55.3% had given birth in the balloon group versus 54.3% in the dinoprostone group. Additional oxytocin stimulation was used more often in the balloon (46%) compared with that in the dinoprostone (34%) (relative risk: 1.34 (95%CI 1.16 -1.54) group. Caesarean section rates and neonatal outcome were similar. Overall, the two methods for induction were comparable with regard to efficacy and safety.

Effectiveness and Safety of the Double Intracervical Balloon vs Dinoprostone in Patients with Previous Cesarean Section.

To compare effectiveness and safety of the Cook's balloon with vaginal dinoprostone to induce labor in patients with previous cesarean section. Observational, and retrospective study that included pregnant women at ≥ 37 weeks' gestation, with unfavorable cervix, singleton pregnancy, intact membranes, and a previous cesarean section, who had undergone labor induction in the period 2014-2019. 170 patients (86 balloon-84 dinoprostone) were analyzed. The proportion of women achieving vaginal delivery within 24 h was higher in the dinoprostone than in double-balloon group (RR, 3.24; 95% CI, 1.36-7.72). No significant differences were detected in the first 48 h in vaginal deliveries (P = .749) or in cesarean section rates (P = .634). Nor were there differences in maternal or fetal safety profiles. A body mass index > 35 increased the risk of cesarean section by 1.53 times (P = .017) and a Bishop's test score < 3 by 1.91 times (P = .009). A vaginal delivery following a cesarean section decreased the probability of another cesarean section by 0.46 times (P = .039). Labor induction with vaginal dinoprostone achieves better vaginal delivery rates in the first 24 h vs Cook's balloon. While the difference in uterine rupture rate did not reach significance, this was higher in women receiving prostaglandin.

Induction of Labour with a Double Balloon Catheter - Comparison of Effectiveness of Six Versus Twelve Hours Insertion Time: a Prospective Case Control Study.

Introduction: Induction of labour is a common obstetric procedure to initiate or augment contractions when labour is delayed or uncertain. The double balloon catheter is a safe and effective mechanical method for cervical ripening during induction of labour. This study evaluates the effectiveness of reducing double balloon catheter insertion time from 12 to 6 hours. Methods: 248 women undergoing induction with a double balloon catheter at term were divided into two groups: catheter placed for 12 hours at 8 pm in the first half of 2021 (P12) and catheter placed for 6 hours at 7 am in the second half of 2021 (P6). T-tests, chi-squared tests, and Wilcoxon signed rank test were used for statistical analysis. Primary and secondary endpoints included induction to delivery interval, prostaglandin to delivery interval, mode of delivery, and maternal and neonatal outcomes. Results: The P6 group had a significantly reduced induction to delivery interval of 558 min (P6: 1348 min, P12: 1906 min, p < 0.01, 95% CI: 376-710) within demographically comparable groups. Multiparous women also showed a significant reduction in prostaglandin to delivery interval of 260 min (P6: 590 min, P12: 850 min, p = 0.038, 95% CI: 9-299). There were no significant differences in mode of delivery, maternal blood loss, or neonatal outcome. Conclusion: Reducing double balloon catheter placement time from 12 to 6 hours resulted in almost 9 hours less induction to delivery interval without adverse effects on maternal and neonatal outcome.

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

BACKGROUND: 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. OBJECTIVE: 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. STUDY DESIGN: 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. RESULTS: 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). CONCLUSION: 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.

Detection of the Vesical Arteries Using Three-dimensional Digital Subtraction Angiography Relevant to Intra-arterial Infusion Chemotherapy for Bladder Cancer Using Double-balloon Catheters.

Purpose: This study aims to assess and measure the origin of the superior vesical artery and its distance from the anterior trunk of the internal iliac artery, to which the anticancer drug is infused via double-balloon-occluded arterial infusion bladder-preserving therapy for locally invasive bladder cancer. Material and Methods: The 160 pelvic sides of 80 patients were analyzed. Double-balloon catheters were bilaterally introduced into the contralateral superior gluteal artery via the internal iliac arteries using a bilateral transfemoral approach. The proximal balloon is placed at the internal iliac artery, proximally from superior gluteal artery bifurcation, whereas the distal balloon at the origin of the superior gluteal artery to isolate the anterior trunk of the internal iliac artery discharging to the targeted vesical arteries between the balloons. The side hole between the distal and proximal balloons was adjusted at the origin of the anterior trunk of the internal iliac artery to allow clear visualization of the angiographic flow into the bladder. After the distal and proximal balloons were inflated, three-dimensional rotational digital subtraction angiography was performed by simultaneous contrast injection from one extension tube connected to bilateral catheters. The distance (X) between the origins of anterior trunk of the internal iliac artery and superior vesical artery was measured on three-dimensional digital subtraction angiography images, and the origin of the inferior vesical artery was investigated. Results: All superior vesical artery originated from anterior trunk of the internal iliac artery. The mean x was 7.2 mm (range 1.0-22.0 mm). All inferior vesical arterys branched from anterior trunk of the internal iliac artery or its branches. Conclusions: Superior vesical artery commonly originates from the proximal portion of anterior trunk of the internal iliac artery close to superior gluteal artery bifurcation.