Routine vaginal examination to assess labour progress at 8 compared to 4 h after early amniotomy following Foley balloon ripening in the labor induction of nulliparas: A randomized trial.

INTRODUCTION: Our objective was to compare the performance of the first vaginal examination at 8 versus 4 h after amniotomy following Foley ripening in nulliparous labor induction. MATERIAL AND METHODS: A randomized controlled trial was conducted from June 2021 to January 2022. 210 nulliparas at term for labor induction were randomized: 105 each to first vaginal examination at 8 or 4 h after Foley balloon ripening and amniotomy. Titrated oxytocin infusion was routinely commenced after amniotomy to expedite labor. Primary outcomes were the amniotomy-to-delivery interval (non-inferiority hypothesis) and maternal satisfaction with their allocated labor care (superiority hypothesis) within 24 h after delivery. Analyses performed using t-test, Mann-Whitney U test, and Chi-squared test as appropriate. RESULTS: The amniotomy-to-delivery interval was mean ± standard deviation 8.7 ± 3.4 versus 8.4 ± 3.7, mean difference 0.4 (97.5% CI: -0.7 to 1.5) hours, p = 0.442 within the pre-specified 2-hour non-inferiority margin, and maternal satisfaction score with allocated labor care was median [interquartile range] 8[7.5-10] versus 8[7.0-10], p = 0.248 for 8 versus 4 h arms, respectively. The amniotomy to first vaginal examination intervals was 5.9 ± 2.3 versus 3.6 ± 1.0 h, p < 0.001, and the number of vaginal examinations was 2[1-2.5] versus 3 [2, 3], p < 0.001 for 8 versus 4 h, respectively. The first vaginal examination was less likely to have been performed as scheduled, more likely to be indicated by the urge to bear down, and non-reassuring cardiotocography for the 8 h arm (p < 0.001). Spontaneous vaginal delivery was significantly more likely and instrumental vaginal delivery less likely, but cesarean rate was not significantly different for the 8 h arm (p = 0.017). CONCLUSIONS: A routine first vaginal examination at 8 h compared to 4 h is non-inferior for the time to birth but does not increase maternal satisfaction although the number of vaginal examinations is fewer. The increase in spontaneous vaginal delivery and reduction in instrumental vaginal delivery rates warrant further powered primary evaluation.

Digital versus Speculum-Based Balloon Catheter Insertion for Labor Induction: A Systematic Review and Meta-Analysis: Digital vs speculum-based balloon IOL.

OBJECTIVES: Induction of labor is commonly undertaken when ongoing pregnancy poses risk to either mother or fetus. Often cervical preparation is required with mechanical methods increasingly popular due to their improved safety. This study evaluates the efficacy, safety, and acceptability of digital versus speculum-based balloon insertion for cervical preparation, aiming to identify gaps and inform future research. DATA SOURCE: PubMed, Ovid MEDLINE, EMBASE, and Scopus were searched from database inception until 30 June 2023. STUDY ELIGIBILITY CRITERIA: Included studies were randomized controlled trials comparing digital versus speculum-based insertion of catheter-related balloons for labor induction in individuals with viable singleton pregnancies, in both inpatient and outpatient settings, written in English. Exclusions included studies not using cervical balloons, comparisons to non-balloon methods, non-human studies, and non-primary literature like guidelines, reviews, commentaries, and opinion pieces. METHODS: Title and abstract screening were performed by four authors. Full-text articles were assessed against inclusion criteria. Selection was agreed upon by consensus among three authors, with a fourth consulted for disputes. Risk of bias was assessed using the Cochrane Risk of Bias Tool 2.0 for randomized trials. A meta-analysis was also performed. RESULTS: Out of 3397 studies, four met the inclusion criteria, all being randomized controlled trials with some concerns in at least one domain but no high risk of bias. Two studies found digital insertion significantly less painful than speculum-based insertion (p<0.001), while one reported no difference (p=0.72). Maternal satisfaction was comparable, with one study favouring digital insertion (p=0.011). Meta-analysis findings for other outcome measures suggest no difference between speculum or digital insertion. However, due to substantial heterogeneity, findings for procedural time, time from induction-to-delivery, and epidural rate should be cautiously interpreted. CONCLUSIONS: Digital insertion for cervical preparation appears associated with reduced pain and higher patient acceptability compared to speculum-based insertion. Additionally, efficacy and safety were comparable, indicating it is a preferable option for clinical use. There was no difference in other procedural, obstetric, or neonatal outcomes, however, more rigorous research employing standardised outcome measures is needed to facilitate a clinically meaningful interpretation.

Efficacy of Dilapan S compared to foley balloon in preinduction cervical ripening-a noninferiority trial.

Background: The need for induction of labor is increasing in present obstetric practice. The available non-pharmacological methods for cervical ripening at term are Foley balloon and Dilapan-S. With the gaining popularity of Dilapan-S worldwide, there are very few clinical trials conducted in India to evaluate its effectiveness. Objective: To compare the efficacy of Dilapan-S and Foley balloons for pre-induction cervical ripening. Study design: This single-center randomized non-inferiority trial included primi- and multi-gravida women between 37 and 41 weeks of gestation and unfavourable cervix with a Bishop's score between 0 and 2. Using a random number table, patients were assigned to study Group 1 Dilapan-S and to control Group 2 Foley balloon. Dilapan-S or Foley balloon was inserted intracervically and assessed for dilation after 12 hours. Patients with unfavourable dilatation were further provided prostaglandins (PgE 1 and 2) for further augmentation of induction. Primary outcome measures included improvement in Bishop's score, and mode of delivery, followed by time to delivery from intervention, use of other augmentation methods, and maternal and neonatal outcomes. Results: After screening, 296 patients with Bishop score less than 2, (148 in each group) were enrolled in the study. The number of patients who had vaginal delivery was comparable between both groups (p=.72), and so were the maternal outcomes. Two cases of cord prolapse occurred with Foley balloon. Group 2 showed significant improvement in Bishop's score (p<.001), and Group 1 had a significantly higher use of augmentation with PgE1 (p-.01) and PgE2 (p<.001). The number of contractions was significantly lower in Group 1 (p<.001), and contraction intensity was higher in Group 2. There was no significant difference in cesarean delivery for failed induction of labor between the groups (p=.72). Based on the primary outcome measure, Dilapan-S was found to be non-inferior to the Foley balloon. Conclusion: Dilapan-S is non-inferior to Foley balloon in achieving pre-induction cervical ripening in term pregnancies, and therefore Dilapan-S can be suggested as an alternative in clinical practice with minimal risks.

Duration of double balloon catheter for patients with prior cesarean: a before and after study.

Background: Previous studies that suggest a shorter time from cervical ripening balloon placement to delivery with shorter total balloon placement time have excluded patients with prior cesarean deliveries. Objective: To evaluate, in patients with a prior history of cesarean delivery undergoing cervical ripening with a double-balloon catheter, whether planned removal of device after 6 vs 12 hours would result in shorter time to vaginal delivery. Study Design: A before-and-after study was performed after a practice change occurred November 2020, shortening the planned time of double-balloon catheter placement for cervical ripening from 12 to 6 hours. Data were collected via retrospective electronic chart review. Primary outcome was time from balloon placement to vaginal delivery. Secondary outcomes included rates of cesarean delivery, maternal intraamniotic infection, and uterine rupture. Kaplan-Meier curves compared median times to delivery between the groups. A Cox proportional-hazards model was used to adjust for time of balloon placement, number of previous vaginal deliveries, and co-medications used. Results: From November 2018 to November 2022, 189 analyzable patients with a prior history of cesarean delivery received a double-balloon catheter for cervical ripening during their trial of labor. Patients were separated into pre- and postpolicy change groups (n=91 and 98, respectively). The median time to vaginal delivery for the pregroup was 28 hours (95% CI: 26, 35) and 25 hours (95% CI: 23, 29) for those in the postgroup (P value .052). After adjusting for dilation at time of balloon placement, number of previous vaginal deliveries, and co-medication, the estimated hazard ratio for successful vaginal delivery postpolicy change was 1.89 (95% CI: 1.27, 2.81). There were no differences in rates of secondary outcomes. Conclusion: In patients with prior cesarean delivery undergoing mechanical cervical ripening with a double-balloon catheter, planned removal at 6 hours compared to 12 hours may result in higher chances of successful vaginal delivery and possibly a shorter time to delivery, without increasing rates of cesarean delivery and intraamniotic infection.

Six vs 12-hour balloon catheter placement for the induction of labor: a systematic review and meta-analysis of randomized controlled trials.

OBJECTIVE: Balloon catheters have shown promising results in the induction of labor (IOL); however, evidence regarding the optimal time of balloon catheter placement is still lacking. Thus, this study aims to evaluate the efficacy and safety of 6-hour placement compared to 12 hours. DATA SOURCE: We conducted a comprehensive search through a search strategy across "Embase, SCOPUS, PubMed (via MEDLINE), and Cochrane Central Register of Controlled Trials (CENTRAL)" from inception until April 20, 2024. STUDY ELIGIBILITY CRITERIA: We included the randomized controlled trials (RCTs) evaluating the efficacy and safety of 6-hour balloon catheter placement compared with 12 hours for cervical ripening in IOL. Covidence was used to screen eligible articles. METHODS: All relevant outcome data were synthesized using risk ratios (RR) or mean differences (MD) with 95% confidence intervals (CIs) in meta-analysis models within RevMan 5.4. PROSPERO ID: CRD42024540935. RESULTS: We included five RCTs with 960 women undergoing the IOL with balloon catheter placement. Six-hour placement was associated with significant lower insertion to overall delivery interval (MD: -4.25, 95% CI [-5.34, -3.15], P<.00001) and insertion to vaginal delivery interval (MD: -4.65, 95% CI [-6.08, -3.23], P<0.00001) without significant difference in BISHOP score change (MD: -0.02, 95% CI [-0.23, 0.20], P=.88), catheter removal to delivery interval (MD: 0.72, 95% CI [-0.39, 1.83], P=.20) and total duration of oxytocin infusion (MD: -0.36, 95% CI [-0.85, 0.14], P=.16) compared to 12 hours. Also, significantly lower overall cesarean delivery (CD) rate (RR: 0.81, 95% CI [0.68, 0.96], P=.01) and CD due to malpresentation (RR: 0.39, 95% CI [0.16, 0.93], P=.03) were observed with 6-hour placement. CONCLUSION: A planned 6-hour balloon catheter placement reduced insertion to delivery intervals and CD rate and has equal efficacy in BISHOP score change and catheter removal to delivery interval compared to 12 hours.

Which approach is better for labor induction: simultaneous or sequential administration of oxytocin and intrauterine balloon-a systematic review and a meta-analysis.

OBJECTIVE: To compare the efficacy of simultaneous and sequential administration of oxytocin and intrauterine balloons in labor induction. METHODS: The databases of Cochrane Library, Web of Science, PubMed, ClinicalTrials.gov, and Embase were thoroughly searched from their inception to November 2023. Randomized controlled trials (RCTs) investigating the simultaneous and sequential use of oxytocin and intrauterine balloons for labor induction in pregnancy were included. The meta-analysis was performed using RevMan 5.3 statistical software. Heterogeneity among the selected studies was evaluated using the I2 statistic. Dichotomous outcomes were estimated using relative risk (RR) with corresponding 95% confidence intervals (CI), while continuous outcomes were measured as the mean difference (MD). RESULTS: A total of eight studies, involving a total of 1,315 nulliparous and multiparous women with an unfavorable cervix, were included in the systematic review. Moreover, a subgroup analysis was conducted, separately evaluating nulliparous and multiparous women. Compared with the sequential groups, simultaneous use of oxytocin and intrauterine balloons resulted in a significantly higher rate of delivery within 24h in nulliparas (RR = 1.30, 95%CI:1.04, 1.63, p = 0.02), a higher rate of vaginal delivery within 24h in multiparas (RR = 1.32, 95%CI:1.15,1.51, p < 0.00001), a superior rate of delivery within 12h and a shorter time to delivery in both nulliparas and multiparas. No statistically significant differences were observed in cesarean delivery and maternal and neonatal adverse outcomes between the sequential and simultaneous groups. CONCLUSIONS: These findings provide support for the simultaneous use of intrauterine balloons and oxytocin during labor induction in nulliparous women. Additionally, this approach may also prove beneficial for multiparas.

Outpatient elective induction of labour at 39 weeks' gestation (HOME INDUCTION): an open-label, randomised, controlled, phase III, non-inferiority trial.

Background: The increased demand for induction of labour (IOL) at 39 weeks' gestation in normal-risk nulliparous patients creates significant logistical challenges for busy maternity units. A potential innovation is commencing induction by means of outpatient cervical ripening, using either a vaginal prostaglandin preparation (Propess) or an osmotic cervical dilator (Dilapan-S). Methods: A Phase III, open label, single centre non-inferiority trial (EudraCT number 2019-004697-25) randomised healthy nulliparous women who chose elective IOL at 39 weeks to one of three methods of initial cervical ripening, specifically 12 h of Dilapan-S(D12), 24 h of Dilapan-S(D24), or 24 h of Propess(P24) between November 2020 and July 2023. After initial administration of the IOL agent in the hospital, participants returned home for 12 or 24 h, before readmission to complete delivery. The primary outcome was vaginal delivery achieved at any time, and this was compared in a non-inferiority analysis of Dilapan-S compared to Propess, within a 10% non-inferiority margin. Secondary outcomes included pairwise comparisons for each induction agent, and a range of logistical factors, such as time to delivery, the need for an additional cervical ripening agent, and length of hospital stay. Findings: Of the 327 women randomised at 38 weeks, 271 (83%) completed the induction intervention. The D24 and P24 groups showed similarly high rates of vaginal delivery, 75% and 76% respectively. D12 had a lower vaginal delivery rate of 64% and consequently the overall comparison of Dilapan-S to Propess did not demonstrate non-inferiority (difference = -6%, 95% CI = -17%, 5%) because the lower 95% CI exceeded the -10% threshold of non-inferiority. The majority of participants across all groups were delivered by any means within 72 h of starting the induction process, inclusive of time spent at home (89% of the D24 group, 98% of the D12 group, 95% of the P24 group). There were no differences in rates of adverse events between groups. Interpretation: There were similarly high vaginal delivery rates for D24 and P24, with at least 75% of patients successfully delivering vaginally following outpatient cervical ripening, with no significant adverse maternal or neonatal outcomes. Funding: The Rotunda Foundation, Medicem Technology s.r.o.

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.

Women's Experiences of Mechanical Balloon Catheter Induction With Self-Traction.

OBJECTIVE: To explore women's experiences of mechanical labor induction using a balloon catheter with self-traction. DESIGN: Descriptive qualitative. SETTING: Birth unit of an urban hospital in Quebec, Canada. PARTICIPANTS: Fourteen women who experienced labor induction with a balloon catheter using self-traction. METHODS: We conducted individual structured interviews between May 2022 and January 2023 to collect data that we subsequently analyzed using the manifest content analysis approach of Graneheim et al. We adhered to the Consolidated Criteria for Reporting Qualitative Research (COREQ). RESULTS: We identified five categories: Expectations, Pain or Comfort Experienced, Emotions Felt, Support From Nursing Staff, and Appreciation of the Procedure. The participants anticipated rapid, effective induction, expressed concerns about potential discomfort, and appreciated control of their experiences. We found a generally positive trend in terms of appreciation for all categories. CONCLUSION: The positive experiences of participants underline the promising potential of the balloon catheter method of labor induction with self-traction. Given the continuing growth in labor induction rates, it becomes necessary to continue efforts to offer services specifically geared to women's needs. Offering an additional option such as self-traction is a step in this direction.

Impact of dinoprostone versus cook cervical ripening balloon on induction in pregnancies complicated by small-for-gestational-age fetuses at term.

OBJECTIVE: To explore the complications and pregnancy outcomes of vaginal dinoprostone vs. Cook's double balloon for the induction of labor among pregnancies complicated by small-for-gestational-age (SGA) at term. METHODS: This retrospective study included consecutive singleton pregnancies complicated by SGA treated at Fujian Maternity and Child Health Hospital between January 2017 and December 2021. The patients were divided into the Cook's double balloon and dinoprostone groups according to the induction method they received. The primary outcome was vaginal delivery. RESULTS: This study included 318 women [165 (aged 30.25 ± 4.72 years) and 153 (aged 28.80 ± 3.91 years) in the dinoprostone and Cook's balloon groups]. The dinoprostone group had a higher vaginal delivery rate than the Cook's balloon group (83.6% vs. 71.9%, p = .012). The cervical ripening duration (9.73 ± 4.82 vs. 17.50 ± 8.77 h, p < .001) and induction to delivery duration (22.11 ± 8.13 vs. 30.27 ± 12.28, p < .001) were significantly shorter in the dinoprostone group compared with the Cook's balloon group. Less women needed oxytocin infusion in the dinoprostone group compared with that in the Cook's balloon group (32.7% vs. 86.3%, p < .001). Dinoprostone was independently associated with vaginal delivery (HR = 1.756, 95%CI: 1.286-2.399, p = .000). The rates of uterine tachysystole and spontaneous rupture of the fetal membrane were significantly higher in the dinoprostone group than that in the Cook's balloon group (10.3% vs. 0.7%, p < .001; 7.3% vs. 1.3%, p = .012). There were no differences in maternal complications and neonatal outcomes between the two groups. CONCLUSION: In pregnant woman with pregnancies complicated by SGA, cervical ripening using dinoprostone were more likely to achieve vaginal delivery than those with Cook's balloon, and with a favorable complication profile.

Double Balloon Combined with Oxytocin in Labor Induction: Analysis of Multivariate Factors Affecting the Efficacy of Cervical Ripening.

Objective: Labor induction during the late trimester of pregnancy is a common option of terminating pregnancy by inducing uterine contractions through medication or cervical mechanical dilation. However, there are few researches on the factors influencing the effectiveness of cervical ripening balloon combined with oxytocin in inducing labor. To explore factors affecting the efficacy of cervical ripening double balloon combined with oxytocin in labor induction. Methods: Using a convenient sampling method, this study retrospectively collected the clinical data of 230 pregnant women who underwent cervical ripening double balloon combined with oxytocin for labor induction in our hospital from September 2021 to August 2022. The included subjects were divided into a vaginal delivery group (n = 180) and a cesarean section group (n = 50) based on the delivery mode for comparing relevant indicators between the two groups. Results: The presence of acute chorioamnionitis (OR = 1.456, 95% CI: 1.257-2.112), fetal distress (OR = 1.371, 95% CI: 1.331-2.633), and the placement of cervical ripening balloon catheter for >12h (OR = 1.563, 95% CI: 1.231-3.263) were risk factors for successful application of cervical ripening double balloon combined with oxytocin for labor induction in pregnant women; while multi-gravidity (OR = 0.736, 95% CI: 0.455-0.875) was a protective factor. In addition, evaluation of the predictive value revealed that acute chorioamnionitis, fetal distress, the placement of cervical ripening balloon catheter for >12h, and gravidity all had certain predictive value for the failure of cervical ripening double balloon combined with oxytocin for labor induction, with the highest predictive value found through joint predictive (AUC: 0.931, 95% CI: 0.714-0.811). Conclusion: Cervical ripening double balloon combined with oxytocin for labor induction may have a high success rate in multigravida. Acute chorioamnionitis, fetal distress, and prolonged placement of the balloon may have a negative impact on the success rate of cervical ripening double balloon combined with oxytocin for labor induction.

The cervicovaginal metabolome in women with favorable induction cervix and those unfavorable for induction when delivering at term.

Background: Cervical ripening is crucial for induction. However, its influencing factors, mechanistic understanding, and effective risk stratification are still challenging. Recent research suggested that microorganisms and their metabolites in vaginal spaces correlate to preterm birth. However, it remains unclear whether the cervicovaginal metabolome is related to the natural physiological process of cervical maturation. Objective: We aimed to analyze the cervicovaginal metabolome in women with favorable induction cervix and those unfavorable for induction when delivering at term. Study design: Cervicovaginal swabs were collected between 40 and 41 weeks gestation from the following 2 different groups of patients: Ripe group (n = 25) which was favorable for the induction cervix and Unripe group which was unfavorable for the induction cervix (n = 25). Samples were tested using untargeted metabolomics analysis and analyzed by a bioinformatics platform. The correlation analysis between the metabolome and the previously acquired microbiome was also performed. Results: A total of 629 metabolites were identified in cervicovaginal fluid. The cervicovaginal metabolome was significantly different between the women with the ripe cervix and those with the unripe cervix, especially within each stratum of the same CST. Metabolites within the amino acid, carbohydrate, and dipeptide pathways may play a role in this distinction. Thirty-four metabolites were significantly upregulated, and the remaining fourteen were significantly downregulated in the Unripe group with an unripe cervix unfavorable for induction. Statistical modeling identified Arachidonic Acid and Nicotinate associated with the risk of cervical maturation disorder (AUC 0.87) in negative ion mode. A combination of Choline and d-Mannose identified a risk of cervical maturation disorder (AUC 0.80) in positive ion mode, improved by Lactobacillus relative abundance (AUC 0.89). Conclusion: These data suggested that the cervicovaginal space was metabolically active during pregnancy and significantly altered among the women with the mature and immature cervix. Combining the genera-level phylotypes and metabolites could build better cervix maturity prediction models. By using cervicovaginal fluid samples, we demonstrated the potential of multi-data type integration for developing composite models toward understanding the contribution of the vaginal environment to the remodeling of cervix during term pregnancy.

Cervical ripening with vaginal Misoprostol plus Hyoscine-N-Butylbromide versus vaginal Misoprostol alone among pregnant women: a double-blind randomised controlled trial.

Objective: To compare cervical ripening time with the use of vaginal Misoprostol plus Hyoscine-N-Butylbromide, with vaginal Misoprostol alone. Design: A double-blind randomized controlled trial with Pan-African Clinical Trials Registry (PACTR) approval number PACTR202112821475292. Setting: Federal Medical Centre, Asaba, Nigeria. Participants: A total of 126 eligible antenatal patients for cervical ripening were enrolled. Interventions: Participants in Group A had 25µg of vaginal misoprostol with 1ml of intramuscular placebo, and those in Group B had 25µg of vaginal misoprostol with 20mg of Intramuscular Hyoscine (1 ml). Oxytocin infusion was used when indicated, and the labour was supervised as per departmental protocol. Main outcome measure: Cervical ripening time. Results: The mean cervical ripening time was statistically significantly shorter in the hyoscine group (8.48±4.36 hours) than in the placebo group (11.40±7.33 hours); p-value 0.02, 95% CI 0.80-5.05. There was no statistically significant difference in the mean induction-delivery interval in Group A (7.38±5.28 hours) compared to Group B (7.75±5.04 hours), with a value of 0.54. The mode of delivery was comparable. However, women in Group B (53, 84.1%) achieved more vaginal deliveries than women in Group A (50, 79.4%); p-value 0.49. Thirteen women in Group A (20.6%) had a caesarean section, while ten women (15.9%) in Group B had a caesarean section (p-value 0.49, RR 0.94, CI 0.80-1.11). Adverse maternal and neonatal outcomes were not statistically significant between the two groups. Conclusion: Intramuscular hyoscine was effective in reducing cervical ripening time when used as an adjunct to vaginal Misoprostol, with no significant adverse maternal or neonatal outcome. Funding: None declared.

Effect of Oral Mifepristone on Modified Bishop's Score in Term Pregnancy.

Background: Modern-day obstetrics recommend induction of labor by medical or mechanical methods where continuation of pregnancy causes detrimental effect to the health of mother or fetus. One of the prerequisites for successful vaginal delivery includes a favorable or ripe cervix. We undertook the present study to find out the safety and efficacy of mifepristone for pre-induction cervical ripening and its effect on Bishop's score in term pregnancy. Methods: A total of 100 patients with term pregnancy were enrolled for this study. 200 mg of mifepristone was administered orally, and efficacy of mifepristone was assessed based on improvement in modified Bishop's score at 48 h. If there was inadequate improvement in Bishop's score after 48 h, additional intracervical cerviprime was administered for induction. Results: Out of 100 patients, 50 women delivered vaginally after administration of mifepristone. Twenty-four patients delivered vaginally within 48 h of administration of mifepristone. We observed the Bishop's score of  6 or more at 48 h in 69% participants. Fifty patients required additional intracervical cerviprime. Thirty participants underwent cesarean section. Mean Modified Bishop's score at 0 h was 1.87 and improved to 6.92 after 48 h after mifepristone. A statistically significant difference was found with mean Bishop's score with p value < 0.005. Conclusion: In our study, we found that mifepristone is a safe and effective cervical ripening agent in term pregnancy with unfavorable cervix. It is well tolerated and leads to significant cervical ripening with improvement in Bishop's score favoring vaginal delivery.

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.

Delivery mode after cervical ripening among patients with no prior vaginal births.

PURPOSE: To compare mode of delivery and maternal and neonatal outcomes using cervical ripening balloon (CRB) for induction of labor (IOL) in nulliparous patients vs. those undergoing first trial of labor after cesarean (TOLAC). METHODS: Retrospective cohort study including data from two tertiary medical centers. Included were all patients with a singleton pregnancy and a gestational age > 37+0 weeks and no prior vaginal birth undergoing IOL with CRB. Nulliparous patients (nulliparous group) were compared to patients with one prior cesarean delivery (CD) and no prior vaginal delivery (TOLAC group). Patients who withdrew consent for trial of labor at any time in both groups were excluded. The primary outcome was mode of delivery. RESULTS: Overall, 161 patients were included in the TOLAC group and 1577 in the nulliparous group. The rate of CD was similar in both groups and remained similar after adjusting for confounders (29.8 % vs. 28.9 %, p = 0.86, OR 1.1, 95 %, CI 0.76-1.58). CD due to fetal distress was more common in the TOLAC group (75 % vs. 56 %, p = 0.014). Other maternal outcomes and neonatal outcomes were similar in the two groups. CONCLUSION: Comparable vaginal delivery rates may be achieved in patients with or without a previous CD attempting their first trial of labor, with a cervical ripening balloon for labor induction, without increasing adverse maternal or neonatal outcomes.

Oxytocin vs oral misoprostol for PROM induction in nulliparas with unfavorable cervix: a randomized trial.

BACKGROUND: Induction of labor (IOL) is recommended following prelabor rupture of membranes (PROM). The optimal method for IOL and need for cervical ripening in those with PROM and an unfavorable cervical examination is unclear. OBJECTIVE: To determine if oxytocin or oral misoprostol results in a shorter time to delivery among nulliparous patients with an unfavorable cervical examination and PROM diagnosis and to evaluate patient satisfaction with both methods. STUDY DESIGN: This is a randomized clinical trial conducted at an urban tertiary care center from 2019 to 2023. Subjects were nulliparas ≥36 weeks with an unfavorable starting cervical exam (≤2 cm and Bishop <8). The primary outcome was time from IOL to delivery in hours compared between oxytocin vs oral misoprostol. Secondary outcomes included suspected intraamniotic infection, cesarean delivery, composite maternal and neonatal morbidity, and patient satisfaction (assessed by Birth Satisfaction Scale-Revised). Sub-group analyses for those with BMI ≥ 30 kg/m2 and cervical dilation ≥1 cm were performed. We required 148 subjects to have 80% power to detect a 2-hour difference in time to delivery. The study was stopped early by the data safety monitoring board due to feasibility concerns in recruiting desired sample size. RESULTS: A total of 108 subjects were randomized: 56 oxytocin; 52 oral miso. The median gestational age at induction was 39.5 weeks; the mean starting cervical dilation was 1.1 cm. There was no statistical difference in time to delivery between groups overall: 14.9 hours oxytocin vs 18.1 hours oral misoprostol (P=.06). In sub-group analyses, there was a 5 hours shorter time to delivery with oxytocin for those with a BMI ≥ 30 kg/m2 (16.6 hours oxytocin vs 21.8 hours oral misoprostol, P .04) and 4.5 hours shorter time to delivery with oxytocin for those with cervix ≥1 cm (12.9 hours oxytocin vs 17.3 hours oral misoprostol, P .04). There were no differences in intraamniotic infection, cesarean delivery, maternal or neonatal morbidity between the groups. Patient satisfaction was higher for those receiving oxytocin compared to misoprostol (29.0 vs 26.3, P=.03). CONCLUSION: Among nulliparas with PROM and an unfavorable cervix, there was no difference in overall time to delivery between oxytocin and oral misoprostol. This result should be interpreted with caution given early study discontinuation and inadequate power. However, a shorter time to delivery with oxytocin was noted in obese patients and those with cervical dilation of at least 1 cm. Furthermore, patient satisfaction was higher in the oxytocin group, and there was no increased risk of neonatal or maternal morbidity with oxytocin.

Predictive Factors for the Success of Vaginal Dinoprostone for the Induction of Labour.

Objective: To evaluate factors predictive of the success of a slow-release dinoprostone vaginal insert for cervical ripening. Methods: This retrospective study included 187 women who received dinoprostone vaginal inserts for cervical ripening. The participants were divided into two groups: the transvaginal delivery group (n = 87) and cesarean section termination group (n = 100). The correlation between the parameters present before cervical ripening with dinoprostone slow release and its success, as well as complications and adverse outcomes, was analyzed. Cesarean section predictors and area under the curve (AUC) were compared between the two Groups. Results: There were statistical differences between the two groups in body mass index (BMI), height, cervical Bishop score, cephalic position, time of medication use, and fetal head position at the time of medication use (P<0.05). The optimal thresholds for identifying cesarean section in dinoprostone vaginal insert for cervical ripening were 162.5 for height (AUC = 0.61), 10.65 cm for amniotic fluid index (AUC = 0.6), S-2.5 for cephalic position (AUC = 0.61), 5.5 for bishop score of cervix (AUC = 0.65). The height, amniotic fluid index, cephalic position, and Bishop score of the cervix were included in the same model. The AUC value of the combined model was higher than the AUC value of the single factor. Conclusion: The combined model was a better predictor of cesarean section in dinoprostone vaginal inserts for cervical ripening and labor induction. The success of cervical ripening with a dinoprostone slow-release vaginal insert can be predicted by the factors that can be recognized at admission.

Relationships Among Mode of Birth, Onset of Labor, and Bishop Score.

OBJECTIVE: To investigate mode of birth in relation to onset of labor and Bishop score. DESIGN: Retrospective observational cohort design. SETTING: A 434-bed Magnet redesignated community hospital. PARTICIPANTS: Nulliparous women, 18 years of age or older, who gave birth at 37 to 41 weeks gestation to live, singleton fetuses in the vertex presentation (N = 701). METHODS: We conducted a retrospective chart review and used chi-square analysis to measure the associations among mode of birth, onset of labor, and Bishop score. We used logistic regression to test the probability of cesarean birth for women undergoing elective induction of labor. RESULTS: Most participants (n = 531, 75.7%) gave birth vaginally. Significant findings included the following relationships: spontaneous onset of labor and vaginal birth (χ2 = 22.2, Ø = 0.18, p < .001) and Bishop score of greater than or equal to 8 and vaginal birth (χ2 = 4.9, Ø = .14, p = .028). Induction of labor was a significant predictor in cesarean birth when controlling for age and body mass index (OR = 2.1, 95% confidence interval [1.5, 3.1], p < .001). CONCLUSION: Reducing elective induction of labor in women with low-risk pregnancies may help lower the risk of cesarean birth. Clinically, Bishop score and mode of birth have a weak association, particularly when induction includes cervical ripening.

Assessing the multifaceted cervix: examining cervical gland area at cervical length screening to predict spontaneous preterm birth.

BACKGROUND: Biologically active cervical glands provide a mucous barrier while influencing the composition and biomechanical strength of the cervical extracellular matrix. Cervical remodeling during ripening may be reflected as loss of the sonographic cervical gland area. As sonographic cervical length remains suboptimal for universal screening, adjunctive evaluation of other facets of the mid-trimester cervix may impart additional screening benefit. OBJECTIVE: To sonographically assess the cervical gland area at universal cervical length screening for preterm birth. STUDY DESIGN: We performed a retrospective cohort study of singletons with transvaginal cervical length screening universally performed during anatomic survey between 18 0/7 and 23 6/7 weeks and subsequent live delivery at a single institution in 2018. Uterine anomalies, cerclage, suboptimal imaging, or medically indicated preterm birth were excluded. Ultrasound images were assessed for cervical length and cervical gland area (with quantitative measurements when present). The primary outcome was spontaneous preterm birth <37 weeks. Absent and present gland groups were compared using χ2, Fisher's exact, T-test, and multivariate logistic regression (adjusting for parity and progesterone use, as well as the gestational age, cervical length, and gland absence at screening ultrasound). Gland measurements were evaluated using the Mann-Whitney-U Test and Spearman's correlation. RESULTS: Among the cohort of 772 patients, absent and present CGA groups were overall similar. Patients were on average 33 years old, ∼20 weeks gestation at screening ultrasound, and overall, 2.5% had history of prior spontaneous preterm birth. The absent gland group was more likely to have been taking progesterone (17% vs 4%, P=.04). Overall rate of preterm birth was 2.6%. However, the 2.3% of patients with absent cervical gland area were significantly more likely to deliver <37 weeks (aOR 23.9, 95% CI 6.4-89, P<.001). Multivariate logistic regression demonstrated better performance of a cervical length screening model for preterm birth prediction with the addition of qualitative gland evaluation (P<.001). Qualitative gland assessment was reproducible (PABAK 0.89), but quantitative gland measurements did not correlate with preterm birth. CONCLUSION: Qualitative gland absence at mid-gestation cervical length screening was associated with subsequent spontaneous preterm birth, whereas quantitative gland measurements were not. Multifaceted ultrasound screening may be needed to adequately evaluate the multiple biologic functions of the cervix.