The efficacy and safety of oral and vaginal misoprostol versus dinoprostone on women experiencing labor: A systematic review and updated meta-analysis of 53 randomized controlled trials.

BACKGROUND: Induction of labor is the process of artificially stimulating the uterus to start labor before the spontaneous onset of labor. It has several medical indications. Commonly used agents are vaginal misoprostol, vaginal prostaglandin E2 (dinoprostone), and oral misoprostol. METHODS: Through October 2023, a literature review was carried out in Cochrane, PubMed, Web of Science, and Scopus to identify randomized clinical studies assessing if oral and vaginal misoprostol has better efficacy of induction of labor over vaginal prostaglandin E2 or dinoprostone as a primary outcome. The data were pooled as mean difference, risk ratio, and 95% confidence interval. RESULTS: Fifty-three RCTs involving 10,455 patients showed a statistically significant difference in the overall success rate of induction between the misoprostol and prostaglandins E2 (PGE2) groups. They required less additional oxytocin compared to the PGE2 groups. The frequency of tachysystole, uterine hyperstimulation, abnormal cardiotocography, meconium-stained amniotic fluid, and Apgar score <7 at 1 minute were all higher in misoprostol groups than in PGE2 groups. No difference was found in cesarean section, fever, Neonatal Intensive Care Unit admission, or Apgar scores at 1 minute or 5 minutes. CONCLUSION: Vaginal misoprostol is more effective at inducing labor but may be less safe than vaginal dinoprostone. Oral misoprostol is generally as safe as vaginal dinoprostone. Vaginal dinoprostone requires lower doses but may need more oxytocin administration.

Factors associated with insufficient cervical ripening in a controlled-release dinoprostone vaginal delivery system: A single perinatal center retrospective study.

OBJECTIVE: In this study, we aimed to evaluate the factors associated with insufficient cervical ripening in a controlled-release dinoprostone vaginal delivery system (Propess). MATERIALS AND METHODS: This retrospective cohort study included 103 pregnant women who used Propess for labor induction. The outcomes were the factors associated with insufficient cervical ripening, defined as a Bishop score ≤6 on the morning after Propess administration. RESULTS: Forty-nine participants had insufficient cervical ripening, and 54 had sufficient cervical ripening. Univariate analysis of these two groups showed that maternal age ≥35 years, early-term delivery (gestational age between 37 and 38 weeks), and Bishop scores at insertion ≤1 were significantly higher in the insufficient cervical ripening group. Multivariate logistic analysis showed that maternal age ≥35 years (adjusted odds ratio: 3.08, 95% confidence interval: 1.29-7.36, p = 0.011) and early-term delivery (adjusted odds ratio: 3.17, 95% confidence interval: 1.23-8.20, p = 0.017) were independent factors associated with poor Propess efficacy. Parity, pre-pregnancy body mass index, body mass index at delivery, and indications for labor induction were not associated with insufficient cervical ripening. CONCLUSIONS: In our study, older maternal age and early-term delivery were independent predictors of insufficient cervical ripening with Propess. More effective delivery management can be achieved by considering induction protocols tailored to individual maternal factors for patients with factors associated with poor Propess efficacy.

Dinoprostone vaginal insert compared to cervical ripening balloon as second line of cervical ripening after first dinoprostone insert.

BACKGROUND AND PROBLEM: To compare dinoprostone vaginal insert (PG) with cervical ripening balloon (CRB) as second line of cervical ripening in women at term with a persistent unfavorable cervix after first PG. METHODS: This retrospective cohort study comprised all women with singleton fetus in cephalic presentation who required cervical ripening at term (≥37 weeks) for maternal and/or fetal disease using repeated PG or CRB for a persistent unfavorable cervix (Bishop score <6) 24 h after first PG. Primary outcome was vaginal delivery rate. Secondary outcomes were favorable cervix (Bishop score ≥6) or labor within 24 h after second device placement, postpartum hemorrhage (PPH) and neonatal morbidity. FINDINGS: 180 women were analyzed (127 repeated PG (70.6 %) and 53 CRB after first PG (29.4 %)). After second device, 93.3 % of women had a favorable cervix (Bishop score ≥6) or were in labor within 24 h, and the rate was significantly higher after CRB, compared to repeated PG (98.1 % vs. 91.3 %; p = 0.048). Vaginal deliveries were similar between groups (62.2 % after repeated PG vs. 54.7 % after CRB; p = 0.36). PPH was observed in 22.2 % of included women, and no difference was observed between groups (21.3 % vs. 21.4 %; p = 0.63). Neonatal morbidity was similar between groups (13.4 % vs. 9.4 %; p = 0.48). CONCLUSION: Vaginal delivery rate and neonatal morbidity were similar when using PG or CRB as second line in women at term with a persistent unfavorable cervix after first PG. CRB seemed to be more efficient on the cervix status, compared to repeated PG, in these women.

Vaginal dinoprostone insert compared with two different oral misoprostol regimens for labor induction in nulliparous and multiparous women.

INTRODUCTION: Labor induction exhibits considerable variations in protocols and medication regimens. Limited studies compare vaginal dinoprostone inserts with different oral misoprostol dosages, considering parity influence. This study explores the distinctions among 10 mg vaginal dinoprostone inserts and oral misoprostol 25 µg every 2 and every 4 h for labor induction, stratified by parity. MATERIAL AND METHODS: This retrospective cohort study involved 607 participants across two hospitals. The primary outcome, time from induction to delivery, and secondary outcomes, including mode of delivery and maternal and fetal safety, were assessed. RESULTS: Patient characteristics revealed differences in indication for labor induction, with the dinoprostone cohort having fewer post-term and premature rupture of membranes cases but more intrauterine growth restriction/small-for-gestational age. Both oral misoprostol regimens showed a shorter time to delivery interval compared to the dinoprostone cohort (median: 1380 min [IQR 1381.0] and 1127.0 min [IQR 1214.0] vs 1631.5 [IQR 1736.2], p < 0.001 and p = 0.014). Only the difference between oral misoprostol q2h and vaginal dinoprostone remained significant for nulliparous but not multiparous women, losing significance over all the population after adjusting for confounding factors. The proportion of women giving birth within 24 h did not significantly differ between misoprostol q2h and dinoprostone after adjusting for confounders. When comparing misoprostol q4h with dinoprostone after confounder adjustment, an increased time to delivery interval for misoprostol q4h was found (p = 0.001). Both oral misoprostol regimens exhibited fewer meconium-stained liquor (miso q4h: OR 0.44, miso q2h: OR 0.34) and cesarean sections (miso q4h: OR 0.48, miso q2h: OR 0.53) compared to dinoprostone, even after adjustment for confounders. CONCLUSIONS: Our study suggests that oral misoprostol 25 µg q4h is less effective than 10 mg vaginal dinoprostone for labor induction if parity and indication for induction are adjusted for, particularly in multiparous women. In terms of side effects, oral misoprostol regimens seem superior to vaginal dinoprostone. Our data support the individualized use of different agents for labor induction according to parity, indication for induction, bishop score, and women's preference.

Cook's balloon versus dinoprostone for Labour induction of term pregnancies with fetal GROWth restriction: study protocol for a randomised controlled trial in tertiary maternity hospitals in Spain (COLIGROW study).

INTRODUCTION: Fetal growth restriction (FGR) affects about 3%-5% of term pregnancies. If prenatally detected and anterograde umbilical artery flow is preserved (stage I), it is recommended to deliver at term (≥ 37+0 weeks). In the absence of contraindications, the vaginal route is preferred, and labour induction is usually required. It has been postulated that mechanical methods for cervical ripening may have an optimal profile for the induction of term FGR fetuses since they are associated with less uterine stimulation than the standard pharmacological methods, and therefore, could be better tolerated by fetuses with reduced placental reserve. This study aims to evaluate whether cervical ripening with a Cook's balloon for the induction of labour from 37+0 weeks of gestation in the stage I FGR manages to increase the rate of vaginal delivery compared with vaginal dinoprostone. METHODS AND ANALYSIS: This will be an open-labelled, randomised, parallel-group clinical trial to be held in five Spanish maternities. Women aged ≥18 years with singleton pregnancies complicated with stage I FGR (defined as the presence of at least one of these two criteria: (1) estimated fetal weight (EFW) <3rd percentile; (2) EFW <10th percentile and at least one of the following: (2.1.) umbilical artery pulsatility index >95th percentile and presence of antegrade end-diastolic flow or (2.2.) Cerebroplacental ratio <5th percentile), gestational age dated by first-trimester ultrasound ≥37+0 weeks at the time of labour induction, cephalic presentation, unfavourable cervix (Bishop score <7), intact fetal membranes, no previous caesarean section and no maternal or fetal contraindications for vaginal delivery or labour induction will be 1:1 randomised by centre to labour induction with Cook's balloon (experimental arm) or dinoprostone (control arm). FGR cases with evidence of non-placental origin (major structural fetal malformations, chromosomal anomalies or congenital infection) will be excluded. The primary outcome is the achievement of a vaginal delivery and it will be assessed by comparing the rates of vaginal delivery in each group using the one-sided χ2 test at an alpha level of 0.025. The sample size has been estimated to observe an expected 84% of vaginal deliveries with Cook's balloon vs 62% with dinoprostone. Therefore, a total of 172 patients (86 per arm) are required (power of 90%, alpha level of 0.025, assuming a percentage of losses of 5%). The efficacy analysis will be performed in the intention-to-treat population. An interim analysis using a two-stage sequential design with the O'Brien-Fleming method will be applied. ETHICS AND DISSEMINATION: The trial was registered in the European Union drug regulating authorities' clinical trials database (EUDRACT) (2021-001726-22) and received approval from the local Research Ethics Committee (21/728) and the Spanish Agency of Medicines and Medical Devices (AEMPS). AEMPS classified the study as a low-intervention trial. The study will be conducted in compliance with the principles of Good Clinical Practice. The study results will be disseminated through workshops and national/international conferences and published in peer-reviewed journals. In addition, they will be disclosed to patients and the public in understandable language through study newsletters and press releases to news and social media. PROTOCOL VERSION: V.1.1, 18 May 2023. TRIAL REGISTRATION NUMBERS: EUDRACT 2021-001726-22 and NCT05774236.

Vaginal dinoprostone vs Foley catheter for induction of labor at term with an unfavorable cervix: an open-label randomized controlled trial.

BACKGROUND: Induction of labor (IOL) with mechanical methods or pharmacological agents is used in about 20% to 30% of all pregnant women. We specialized in comparing the effectiveness and safety of dinoprostone vs transcervical Foley catheter for IOL in term pregnant women with an unfavorable cervix with adequate samples. OBJECTIVE: To compare the effectiveness and safety of dinoprostone vs transcervical Foley catheter for IOL in term pregnant women with an unfavorable cervix. STUDY DESIGN: This is a parallel, open-label randomized controlled trial in two maternal centers in Shanghai, China between October 2019 and July 2022. Women with a singleton pregnancy in cephalic presentation at term and an unfavorable cervix (Bishop score <6) scheduled for IOL were eligible. A total of 1860 women were randomly allocated to cervical ripening with either a dinoprostone vaginal insert (10 mg) or a 60 cc Foley catheter for up to 24 hours. The primary outcomes were vaginal delivery rate and time to vaginal delivery. Secondary outcomes included time to delivery and maternal and neonatal morbidity. Analysis was done from an intention-to-treat perspective. The trial was registered with the China trial registry (CTR2000038435). RESULTS: The vaginal birth rates were 72.8% (677/930) vs 69.9% (650/930) in vaginal dinoprostone and Foley catheter, respectively (aRR 1.04, 95% confidence interval [CI] 0.98-1.10, risk difference: 0.03). Time to vaginal delivery was not significantly different between the two groups (sub-distribution hazard ratio 1.11, 95% CI 0.99-1.24). Vaginal dinoprostone was more likely complicated with hyperstimulation with fetal heart rate changes (5.8% vs 2.8%, aRR 2.09, 95% CI 1.32-3.31) and placenta abruption (0.9% vs 0.1%, aRR: 8.04, 95% CI 1.01-64.15), while Foley catheter was more likely complicated with suspected intrapartum infection (5.1% vs 8.2%, aRR: 0.62, 95% CI 0.44-0.88) and postpartum infection (1.4% vs 3.7%, aRR: 0.38, 95% CI 0.20-0.72). The composite of poor neonatal outcomes was not significantly different between the two groups (4.5% vs 3.8%, aRR 1.21, 95% CI 0.78-1.88), while more neonatal asphyxia occurred in the dinoprostone group (1.2% vs 0.2%, aRR 5.39, 95% CI 1.22-23.92). In a subgroup analysis, vaginal dinoprostone decreased vaginal birth rate slightly in multiparous women (90.6% vs 97.0%, aRR 0.93, 95% CI 0.88-0.99). CONCLUSIONS: In term pregnant women with an unfavorable cervix, IOL with vaginal dinoprostone or Foley catheter has similar effectiveness. Foley catheter leads to better safety for neonates, while it may result in a higher risk of maternal infection. Furthermore, Foley catheter should be preferred in multiparous women.

Use of vaginal dinoprostone for women with term prelabor rupture of membranes and an unfavorable cervix within 6 h versus within 6-24 h.

BACKGROUND: Most guidelines propose inducing labor within 24 h following term (37 or more weeks of gestation) prelabor rupture of membranes (PROM). However, the exact timing for initiating induction within the 24 h period remains unknown. This study aims to comparatively assess the efficacy and safety of the use of vaginal dinoprostone within 6 h versus within 6-24 h for singleton pregnancies with PROM and an unfavorable cervix (Bishop score < 6). METHODS: This was a retrospective cohort study including singleton pregnancies with PROM and an unfavorable cervix (Bishop score < 6) in which labor was induced using vaginal dinoprostone. Women were divided into two groups according to the timing of the use of induction (within 6 h versus within 6-24 h after PROM). Baseline maternal data, maternal and neonatal outcomes were recorded for statistical analysis. RESULTS: 450 women were included, 146 (32.4%) of whom were induced within 6 h of PROM and 304 (67.6%) were induced within 6-24 h. Cesarean delivery rate (15.8% versus 29.3%, p = 0.002) and nonreassuring fetal heart rate tracing (4.8% versus 10.5%, p = 0.043) in group with vaginal dinoprostone within 6 h were significantly lower than those in group with vaginal dinoprostone within 6-24 h. There was no significant differences in terms of duration from IOL to vaginal delivery. CONCLUSION: Induction of labor within 6 h with vaginal dinoprostone after PROM for singleton pregnancies with an unfavorable cervix (Bishop score < 6) significantly associated with less cesarean section, less nonreassuring fetal heart rate tracing, compared to induction of labor within 6-24 h after PROM.

Effect of acidic vaginal pH on the efficacy of dinoprostone (PGE2) vaginal tablet for labor induction in full term pregnant women: a randomized controlled trial.

OBJECTIVES: There is controversial evidence that acidification of vaginal pH may increase the efficacy of vaginal prostaglandins in labor induction, with research being mainly focused on misoprostol. This study aims to evaluate the impact of this intervention on the progress of labor induction with dinoprostone (PGE2) vaginal tablet. METHODS: This double-blind, parallel-group, randomized study was conducted between October 2021 and December 2022 at Alexandra General Hospital, Athens, Greece. A total of 230 women with singleton, full term pregnancy that were scheduled for labor induction were randomly divided into two groups: Group A, who received acidic vaginal wash (5 % acetic acid) and Group B, who received a normal saline vaginal wash. Afterwards, participants received a vaginal tablet of 3 mg dinoprostone every 6 h (maximum two doses). RESULTS: There were no statistically significant differences in mode of delivery, duration of different labor stages, Bishop score changes and possible complications. Participants in the acidification group needed less often labor augmentation with oxytocin and epidural anesthesia (p=0.03). CONCLUSIONS: Vaginal acidification seems to have no effect on the efficacy of the dinoprostone vaginal tablet. Even though it may reduce the need for oxytocin augmentation, there is no apparent benefit on clinical outcomes, such as reduction in cesarean section rates or shorter labor duration. Future research is necessary in order to validate these findings.

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.

Patient experience in prostaglandins-induced cervical ripening: A comparative study using a standardized questionnaire.

OBJECTIVE: Cervical ripening for induction of labor is often associated with negative patient experience. The debate over the most effective cervical ripening method persist, with a significant gap in research specifically addressing patient satisfaction. Our study aims to compare patient experience with two induction methods, slow-release intravaginal dinoprostone device and orally administered misoprostol. METHOD: We conducted a before-and-after comparative study at a university tertiary hospital, including all patients undergoing cervical ripening with a Bishop score of 3 or lower. Our study compared two separate two-month periods, where the methods for cervical ripening differed. The first period employed an intravaginal dinoprostone slow-release device, while the second period used oral misoprostol. The primary outcome was patient experience, assessed using the EXIT questionnaire, a standardized and validated self-reported measure. Secondary outcomes were efficacy and safety outcomes. RESULTS: A total of 165 patients were included, 81 induced with dinoprostone and 84 induced with misoprostol. The EXIT questionnaire completion rate was 67.9 % (n = 55) in the dinoprostone group and 76.1 % (n = 64) in the misoprostol group (p = 0.23). Patients induced with misoprostol reported higher levels of satisfaction compared to those induced with dinoprostone, which can be attributed to reduced discomfort associated with the induction process (mean satisfaction score 2.26 ± 0.98 versus 2.80 ± 0.85 on a 1 to 5 likert-scale, p-value < 0.01). Adverse effects were reported less frequently with misoprostol compared to dinoprostone (20.2 % vs 48.1 %, p-value < 0.01). Time between cervical ripening and delivery was shorter in the misoprostol group (27.0 ± 10.2 h vs 32.5 ± 10.0, p < 0.01). There were no difference in mode of delivery or other obstetrical and neonatal outcomes. CONCLUSION: For women undergoing cervical ripening, oral misoprostol appears to be a less invasive method for labor induction, associated with higher levels of satisfaction and reduced discomfort compared to the intravaginal dinoprostone slow-release device.

Short stature and vaginal dinoprostone as independent predictors of composite maternal-newborn adverse outcomes in induction of labor after one previous cesarean: a retrospective cohort study.

BACKGROUND: The rates of labor induction and cesarean delivery is rising worldwide. With the confluence of these trends, the labor induction rate in trials of labor after cesarean can be as high as 27-32.7%. Induction of labor after one previous cesarean (IOLAC) is a high-risk procedure mainly due to the higher risk of uterine rupture. Nevertheless, the American College of Obstetricians and Gynecologists considers IOLAC as an option in motivated and informed women in the appropriate care setting. We sought to identify predictors of a composite of maternal and newborn adverse outcomes following IOLAC. METHODS: The electronic medical records of women who delivered between January 2018 to September 2022 in a Malaysian university hospital were screened to identify cases of IOLAC. A case is classified as a composite adverse outcome if at least one of these 11 adverse outcomes of delivery blood loss ≥ 1000 ml, uterine scar complications, cord prolapse or presentation, placenta abruption, maternal fever (≥ 38 0C), chorioamnionitis, intensive care unit (ICU) admission, Apgar score < 7 at 5 min, umbilical artery cord artery blood pH < 7.1 or base excess ≤-12 mmol/l, and neonatal ICU admission was present. An unplanned cesarean delivery was not considered an adverse outcome as the practical management alternative for a clinically indicated IOLAC was a planned cesarean. Bivariate analysis of participants' characteristics was performed to identify predictors of their association with composite adverse outcome. Characteristics with crude p < 0.10 on bivariate analysis were incorporated into a multivariable binary logistic regression analysis model. RESULTS: Electronic medical records of 19,064 women were screened. 819 IOLAC cases and 98 cases with composite adverse outcomes were identified. Maternal height, ethnicity, previous vaginal delivery, indication of previous cesarean, indication for IOLAC, and method of IOLAC had p < 0.10 on bivariate analysis and were incorporated into a multivariable binary logistic regression analysis. After adjustment, only maternal height and IOLAC by vaginal dinoprostone compared to Foley balloon remained significant at p < 0.05. Post hoc adjusted analysis that included all unplanned cesarean as an added qualifier for composite adverse outcome showed higher body mass index, short stature (< 157 cm), not of Chinese ethnicity, no prior vaginal delivery, prior cesarean indicated by labor dystocia, and less favorable Bishop score (< 6) were independent predictors of the expanded composite adverse outcome. CONCLUSION: Shorter women and IOLAC by vaginal dinoprostone compared to Foley balloon were independently predictive of composite of adverse outcome.

Shorter stature and dinoprostone labor induction are independent predictors of a composite maternal-newborn adverse outcome excluding unplanned cesarean 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.

Comparing labour induction outcomes using misoprostol and dinoprostone in term pregnancies: A retrospective study at Kiambu Level 5 Hospital between 2018 and 2020.

BACKGROUND: The Maternal and Perinatal Death Surveillance and Response (MPDSR) was introduced in Kenya in 2016 and implemented at Kiambu Level 5 Hospital (KL5H) three years later in 2019. During a routine MPDSR meeting at KL5H, committee members identified a possible link between the off-label use of 200mcg misoprostol tablets divided eight times to achieve the necessary dose for labour induction (25mcg) and maternal deaths. Following this, an administrative decision was made to switch from misoprostol to dinoprostone for the induction of labour in June of 2019. This study aimed to assess the overall impact of MPDSR as well as the effect of replacing misoprostol with dinoprostone on uterine rupture, maternal and neonatal deaths at KL5H. METHODS: We conducted a retrospective cohort study of women who gave birth at KL5H between January 2018 and December 2020. We defined the pre-intervention period as January 2018-June 2019, and the intervention period as July 2019-December 2020. We randomly selected the records of 411 mothers, 167 from the pre-intervention period and 208 from the intervention period, all of whom were induced. We used Bayes-Poisson Generalised Linear Models to fit the risk of uterine rupture, maternal and perinatal death. 12 semi-structured key person questionnaires was used to describe staff perspectives regarding the switch from misoprostol to dinoprostone. Inductive and deductive data analysis was done to capture the salient emerging themes. RESULTS: We reviewed 411 patient records and carried out 12 key informant interviews. Mothers induced with misoprostol (IRR = 3.89; CI = 0.21-71.6) had an increased risk of death while mothers were less likely to die if they were induced with dinoprostone (IRR = 0.23; CI = 0.01-7.12) or had uterine rupture (IRR = 0.56; CI = 0.02-18.2). The risk of dying during childbearing increased during Jul 2019-Dec 2020 (IRR = 5.43, CI = 0.68-43.2) when the MPDSR activities were strengthened. Induction of labour (IRR = 1.01; CI = 0.06-17.1) had no effect on the risk of dying from childbirth in our setting. The qualitative results exposed that maternity unit staff preferred dinoprostone to misoprostol as it was thought to be more effective (fewer failed inductions) and safer, regardless of being more expensive compared to misoprostol. CONCLUSION: While the period immediately following the implementation of MPDSR at KL5H was associated with an increased risk of death, the switch to dinoprostone for labour induction was associated with a lower risk of maternal and perinatal death. The use of dinoprostone, however, was linked to an increased risk of uterine rupture, possibly attributed to reduced labour monitoring given that staff held the belief that it is inherently safer than misoprostol. Consequently, even though the changeover was warranted, further investigation is needed to determine the reasons behind the rise in maternal mortalities, even though the MPDSR framework appeared to have been put in place to quell such an increase.

Comparative study of second-line labor induction methods in patients with unfavorable cervix after first-line low-dose oral misoprostol.

OBJECTIVE: The present study aimed to evaluate low-dose oral misoprostol induction, and compare different methods used in second-line induction in patients with a Bishop score less than 6. METHODS: This retrospective study analyzed the medical history and courses of pregnancy of all patients induced with first-line of low-dose oral misoprostol (50 µg every 4 h with a total of 200 µg/24 h) from April 2021 to June 2022 in a university hospital center, and reported outcomes according to the second-line method of induction. RESULTS: Among 437 labor inductions with low-dose oral misoprostol, 120 patients required a second-line induction. Predictive factors of first-line failure were higher body mass index (P = 0.011), absence of premature rupture of membranes (P = 0.021) and earlier term of pregnancy (P < 0.001). Regarding second methods of induction of labor, time from induction to delivery was shorter in the oxytocin group than the dinoprostone and misoprostol groups (24.0 vs. 41 and 51.0 h, respectively; P < 0.001), and was also significantly shorter in the dinoprostone than the misoprostol group (P = 0.048). Cesarean section rates did not differ between the three groups (P = 0.651). There were no clinically significant differences in adverse events between the groups. CONCLUSION: Normal body mass index, previous rupture of membranes and later term of induction of labor were the three favoring success factors during first-line oral misoprostol. In cases of a Bishop score <6, oxytocin may be the best option to reduce duration to delivery, with the same maternal-fetal outcomes, including a similar rate of vaginal delivery.

Vaginal misoprostol versus vaginal dinoprostone for cervical ripening and induction of labour: An individual participant data meta-analysis of randomised controlled trials.

BACKGROUND: Induction of labour (IOL) is common practice and different methods carry different effectiveness and safety profiles. OBJECTIVES: To compare the effectiveness, and maternal and perinatal safety outcomes of IOL with vaginal misoprostol versus vaginal dinoprostone using individual participant data from randomised clinical trials. SEARCH STRATEGY: The following databases were searched from inception to March 2023: CINAHL Plus, ClinicalTrials.gov, Cochrane Pregnancy and Childbirth Group Trial Register, Ovid Embase, Ovid Emcare, Ovid MEDLINE, Scopus and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). SELECTION CRITERIA: Randomised controlled trials (RCTs), with viable singleton gestation, no language restrictions, and all published and unpublished data. DATA COLLECTION AND ANALYSIS: An individual participant data meta-analysis was carried out. MAIN RESULTS: Ten of 52 eligible trials provided individual participant data, of which two were excluded after checking data integrity. The remaining eight trials compared low-dose vaginal misoprostol versus dinoprostone, including 4180 women undergoing IOL, which represents 32.8% of all participants in the published RCTs. Of these, 2077 were assigned to low-dose vaginal misoprostol and 2103 were assigned to vaginal dinoprostone. Compared with vaginal dinoprostone, low-dose vaginal misoprostol had a comparable rate of vaginal birth. Composite adverse perinatal outcomes did not differ between the groups. Compared with vaginal dinoprostone, composite adverse maternal outcomes were significantly lower with low-dose vaginal misoprostol (aOR 0.80, 95% CI 0.65-0.98, P = 0.03, I2 = 0%). CONCLUSIONS: Low-dose vaginal misoprostol and vaginal dinoprostone for IOL are comparable in terms of effectiveness and perinatal safety. However, low-dose vaginal misoprostol is likely to lead to a lower rate of composite adverse maternal outcomes than vaginal dinoprostone.

Cervical ripening balloon compared with vaginal dinoprostone for cervical ripening in obese women at term: A prospective cohort study.

OBJECTIVE: To evaluate vaginal delivery in obese women who underwent cervical ripening at term using a dinoprostone vaginal insert or a cervical ripening balloon (CRB), and to assess maternal and neonatal morbidity according to the method. METHODS: A prospective cohort study including obese women with a live singleton fetus in cephalic presentation who required cervical ripening at term (≥37 weeks) for maternal and/or fetal disease using a dinoprostone vaginal insert or a CRB. The primary outcome was vaginal delivery. Secondary outcomes were a favorable cervix (Bishop score >6) after 24 h, the time from device insertion to delivery, and composite maternal and neonatal morbidity. RESULTS: In total, 135 consecutive women were analyzed (107 CRB, 79.3%; 28 dinoprostone vaginal insert, 20.7%). Vaginal delivery (86 [80.4%] after CRB vs 19 [67.9%] after dinoprostone vaginal insert; P = 0.248), favorable cervix within 24 h after device placement (52 [48.6%] vs 17 [60.7%]; P = 0.264), and maternal morbidity (12 [11.2%] vs 4 [14.3%]; P = 0.646) were similar between the groups. The time from device insertion to delivery also did not differ between the groups. Neonatal morbidity was significantly higher after the dinoprostone vaginal insert (11 [39.3%] vs 20 [18.7%]; P = 0.030). Cervical ripening using the dinoprostone vaginal insert, compared with the CRB, was significantly associated with neonatal morbidity (adjusted odds ratio 4.00, 95% confidence interval 1.34-12.5), but not with maternal morbidity (adjusted odds ratio 1.23, 95% confidence interval 0.30-4.38). CONCLUSIONS: Vaginal delivery, a favorable cervix after 24 h, the time from device insertion to delivery, and maternal morbidity did not significantly differ between the CRB and the dinoprostone vaginal insert for cervical ripening in obese women at term. Nevertheless, neonatal morbidity was significantly associated with the dinoprostone vaginal insert, compared with the CRB, among obese women who required cervical ripening at term.

Outpatient cervical ripening with balloon catheters: A Bayesian network meta-analysis of randomized controlled trials.

BACKGROUND: One in four labors are induced. The process of cervical ripening can be lengthy and pre-labor hospitalization is required. Outpatient cervical ripening can be an attractive alternative. OBJECTIVES: To evaluate the efficacy and safety of outpatient cervical ripening with a balloon catheter compared with inpatient balloon catheter or prostaglandin E2 (PGE2). SEARCH STRATEGY: The PubMed, MEDLINE, Embase, ClinicalTrials.gov, and Cochrane Library databases were searched from their inception to October 15, 2022. SELECTION CRITERIA: Randomized controlled trials comparing the outpatient balloon catheter with inpatient balloon catheter or inpatient PGE2 for term cervical ripening. DATA COLLECTION AND ANALYSIS: Bayesian network meta-analysis was performed. The primary outcome was the cesarean delivery rate. The secondary outcomes included instrumental delivery, the time from intervention-to-birth, oxytocin augmentation, total hospital duration, and maternal/neonatal adverse events. MAIN RESULTS: Twenty-nine randomized controlled trials with a total of 6004 participants were identified. No difference in the cesarean delivery rate was revealed among the three interventions. Compared with inpatient balloon catheter, outpatient balloon catheter had shorter total hospital duration (mean difference -8.58, 95% confidence interval -17.02 to -1.10). No differences were revealed in the time from intervention-to-birth, instrumental delivery, postpartum hemorrhage, 5-min Apgar score less than 7, umbilical cord arterial pH less than 7.1, and neonatal intensive care unit admission among the three interventions. CONCLUSIONS: Outpatient balloon catheter in low-risk term pregnancies is an available option that could be considered for cervical ripening. The safety and effectiveness are comparable to inpatient cervical ripening methods.

Oxytocin and vaginal dinoprostone in labor induction: A systematic review and meta-analysis.

BACKGROUND: The comparison between prostaglandin E2 (PGE2) and oxytocin and for induction of labor (IOL) remains controversial. OBJECTIVE: The present study aimed to determine the safety and efficacy of these two agents in IOL. SEARCH STRATEGY: PubMed, Embase, Web of Science, Cochrane Library, and ClinicalTrials.gov. from the establishment of the database to April 23, 2023. SELECTION CRITERIA: A search was conducted with keywords "labor, induction, prostaglandin E2/PGE2/dinoprostone, and oxytocin". Only randomized clinical trials comparing oxytocin and vaginal dinoprostone in women who were at least late preterm (gestational age [GA] ≥34 weeks), singleton pregnant, and had intact membranes were enrolled for further meta-analysis. DATA COLLECTION AND ANALYSIS: We conducted both a descriptive analysis and a meta-analysis. In the meta-analysis, we utilized the Mantel-Haenszel random effects model to analyze dichotomous data, employing the relative risk (RR) as the effect measure along with 95% confidence intervals (CIs). The study quality was evaluated using Cochrane Collaboration's risk of bias assessment tool (RoB 2). A random-effects model was applied for the meta-analysis. MAIN RESULTS: After screening 3303 articles from five databases, a total of nine randomized controlled studies composed of 1071 patients were included. Our analysis included 534 patients in the PGE2 group and 537 patients in the oxytocin group. The pooled estimate of vaginal deliveries following PGE2 induction stood at 84.2%, while after oxytocin induction, it was 79.8%. The meta-analysis showed no statistical difference between the two groups in terms of the rate of vaginal delivery (pooled RR, 1.05; 95% CI: 0.95-1.16; P value for Q, 0.001; I2, 71.14%), cesarean section (pooled RR, 0.84; 95% CI: 0.52-1.35; P value for Q, 0.007; I2, 61.69%) and induction-delivery interval (pooled standard mean difference, 0.09; 95% CI: -0.67 to 0.85; P value for Q, 0.000; I2, 96.45%). Since the results for fetal distress and uterine hyperstimulation were consistent across all enrolled studies, no further meta-analysis was conducted. CONCLUSIONS: When amalgamating the available literature, it implies that oxytocin was found to have similar effects as PGE2 on delivery outcomes and safety concerns in pregnant women with GA ≥36 weeks. Although the uterine cervix was unfavorable, both low and high doses of oxytocin were feasible for IOL.

Using dinoprostone slow release vaginal insert for cervical ripening in term-pregnancy with oligohydramnios.

AIMS: The study purposed to evaluate the success rate of cervical ripening using dinoprostone controlled-release vaginal insert and reveal some factors relating to successful cervical ripening. METHODS: This cross-sectional study was conducted at Tu Du Hospital in Vietnam from December 2021 to August 2022. The study enrolled 200 pregnant women with gestational age ≥37 weeks diagnosed with oligohydramnios. These candidates underwent dinoprostone cervical ripening (DCR) according to the local protocol. The Bishop score ≥7 after 24 h was determined for the successful cervical ripening (SCR). RESULTS: In total, the success rate of DCR achieved at 57.5% and the cesarean delivery rate was 46.5%. None of the severe side-effects and complications was present. Using multivariable logistic regression, the study found that the body mass index ≥25 kg/m2 and oxytocin infusion drip related to SCR with adjusted odds ratio (aOR): 3.67 (95% confidence intervals [CI]: 1.78-7.57) and aOR: 4.68 (95% CI: 1.84-11.93), p < 0.001. Using the Kaplan-Meier curve, the present study revealed a significant difference between Bishop <3 and ≥3 following the duration time of cervical ripening, with hazard ratio: 1.38 (95% CI: 1.19-1.59), p < 0.001. The time duration of cervical ripening was not significantly different following amniotic fluid index from 3 to 5 cm. CONCLUSIONS: Cervical ripening using a dinoprostone vaginal insert is a potentially acceptable method in term pregnancy accompanying with oligohydramnios. The probability of SCR can be predicted on a careful assessment of relative factors by obstetricians. Further studies are required to strengthen these findings.

Effectiveness of dinoprostone gel, misoprostol vaginal insert and dinoprostone vaginal insert for induction of labour in twin pregnancies.

OBJECTIVES: To compare the effectiveness and safety of Dinoprostone Gel (DG), Misoprostol Vaginal Insert (MVI) and Dinoprostone Vaginal Insert (DVI) for induction of labour (IOL) in twin pregnancies. STUDY DESIGN: Retrospective cohort study of twin pregnancies > 34 + 0 weeks gestation that underwent induction of labour (IOL) with DG, MVI or DVI between December 2016 and November 2019 in a Tertiary NHS hospital, North West England, UK. Delivery characteristics, maternal complications and neonatal outcomes were compared between the three groups. RESULTS: A total of 87 twin pregnancies were included for analysis. 27 women received DG, 34 received MVI and 26 DVI. The MVI cohort had a higher proportion of nulliparous women (55.9%) compared to the DG and DVI cohorts, 29.6% and 38.5% respectively. No other differences amongst demographic characteristics were considered clinically significant. DG demonstrated a significantly quicker time to delivery (minutes) compared to DVI (1021 ± 556 versus 1649 ± 852; P = 0.0026). Significantly fewer women required terbutaline for hyperstimulation/tachysystole in the DG group compared to MVI (0% vs 32%; RR 0.05; 95% CI 0.003-0.88). Both DG and MVI groups required significantly less oxytocin following artificial rupture of membranes compared to DVI (33% vs 65%; RR 0.51; 95% CI 0.28-0.93) and (29% vs 65%; RR 0.45; 95% CI 0.25-0.81). There were no significant differences in mode of delivery, maternal complications and neonatal outcomes. CONCLUSION: Our data suggests that for women with a twin pregnancy considering a planned labour that induction with DG, MVI and DVI appear to be equally safe and effective IOL methods. These results should be interpreted with caution due to the study being underpowered to detect significant adverse outcomes. In order to determine the optimal method of IOL in twins, direct randomised comparison is needed.