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.

Different expressions of aquaporin water channels and macrophages infiltration in human cervix remodeling during pregnancy.

Despite aquaporin water channels (AQPs) play a critical role in maintaining water homeostasis in female reproductive tract and prompt a gradual increase in water content in cervical edema as pregnancy progressed, their relationship with macrophage infiltration and collagen content in human cervical remodeling need to be further investigated. This is the first study to examine the expression and localization of AQP3, AQP4, AQP5, AQP8, and macrophages simultaneously in human cervical ripening. The immunoreactivity of these AQPs was 2.6 to 6-fold higher on gestational weeks 26 (GD26W) than that on GD6W and GD15W, but AQP4 expression on GD39W dropped a similar extent on GD15W, other AQPs continued to rise on GD39W. The AQP3, AQP4, and AQP5 intensity seemed more abundant in cervical stroma than in the perivascular area on GD26W; the distribution of AQP3, AQP5, and AQP8 in cervical stroma was equivalent to that in the perivascular area on GD39W. Macrophage numbers were 1.7-fold higher in subepithelium region and 3.0-fold higher in center area on GD26W than that on GD15W; such numbers remained elevated on GD39W. The electron micrographs showed that cervical extensibility increased significantly on GD26W and GD39W accompanied with increased macrophage infiltration, cervical water content, and much more space among collagen fibers. These findings suggest that the upregulation of AQPs expression in human cervix is closely related to enhanced macrophage infiltration during pregnancy; there may be a positive feedback mechanism between them to lead the increase of water content and the degradation of collagen.

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.

The efficacy and safety of second dinoprostone pessary or balloon catheter after unsuccessful primary ripening with dinoprostone pessary.

We investigated which treatment should be applied if primary cervical ripening with a dinoprostone pessary is unsuccessful. We included 281 women who experienced unsuccessful cervical ripening with a dinoprostone pessary and continued on induction of labour (IOL). Of the 281 women recruited, 177 were given a second dose of dinoprostone; 104 women received a balloon catheter. The second dinoprostone pessary was successful in achieving vaginal delivery in 88 of the 177 (48.6%) women, while the balloon catheter was successful in 42 of the 104 women (40.4%); there was no significant difference between the two treatments with regards to successful vaginal delivery. However, of the women who experienced successful vaginal delivery, the delivery rate in the dinoprostone group was significantly higher than that in the balloon catheter group 12, 24, 36, or 48 h after insertion (p = .0094, .0005, .0258, .0483, respectively). The neonatal outcomes, the proportion of maternal infection and postpartum haemorrhage were similar between the two groups.IMPACT STATEMENTWhat is already known on this subject? Labour induction is a common procedure in obstetrics in a bid to achieve vaginal delivery in China, because vaginal delivery is more beneficial and associated with a better quality of life as compared to a Caesarean delivery. There is consensus relating to the preferred method of IOL after unsuccessful IOL with a dinoprostone pessary.What do the results of this study add? This is the first study in a Chinese population to compare the dinoprostone pessary and balloon catheter for women with no response to dinoprostone for cervical ripening with a sample size greater than 100. We found that a second dose of dinoprostone can reduce the time from the re-initiation of IOL to vaginal delivery compared with the balloon catheter. Our data also indicated that all other outcomes relating to the mother and infant were similar.What are the implications of these findings for clinical practice and/or future research? A second dose of dinoprostone is a superior choice for women who experience unsuccessful IOL with dinoprostone to further accelerate vaginal delivery.

Cervical ripening in prolonged pregnancies by silicone double balloon catheter versus vaginal dinoprostone slow release system: The MAGPOP randomised controlled trial.

BACKGROUND: Prolonged pregnancies are a frequent indication for induction of labour. When the cervix is unfavourable, cervical ripening before oxytocin administration is recommended to increase the likelihood of vaginal delivery, but no particular method is currently recommended for cervical ripening of prolonged pregnancies. This trial evaluates whether the use of mechanical cervical ripening with a silicone double balloon catheter for induction of labour in prolonged pregnancies reduces the cesarean section rate for nonreassuring fetal status compared with pharmacological cervical ripening by a vaginal pessary for the slow release of dinoprostone (prostaglandin E2). METHODS AND FINDINGS: This is a multicentre, superiority, open-label, parallel-group, randomised controlled trial conducted in 15 French maternity units. Women with singleton pregnancies, a vertex presentation, ≥41+0 and ≤42+0 weeks' gestation, a Bishop score <6, intact membranes, and no history of cesarean delivery for whom induction of labour was decided were randomised to either mechanical cervical ripening with a Cook Cervical Ripening Balloon or pharmacological cervical ripening by a Propess vaginal pessary serving as a prostaglandin E2 slow-release system. The primary outcome was the rate of cesarean for nonreassuring fetal status, with an independent endpoint adjudication committee determining whether the fetal heart rate was nonreassuring. Secondary outcomes included delivery (time from cervical ripening to delivery, number of patients requiring analgesics), maternal and neonatal outcomes. Between January 2017 and December 2018, 1,220 women were randomised in a 1:1 ratio, 610 allocated to a silicone double balloon catheter, and 610 to the Propess vaginal pessary for the slow release of dinoprostone. The mean age of women was 31 years old, and 80% of them were of white ethnicity. The cesarean rates for nonreassuring fetal status were 5.8% (35/607) in the mechanical ripening group and 5.3% (32/609) in the pharmacological ripening group (proportion difference: 0.5%; 95% confidence interval (CI) -2.1% to 3.1%, p = 0.70). Time from cervical ripening to delivery was shorter in the pharmacological ripening group (23 hours versus 32 hours, median difference 6.5 95% CI 5.0 to 7.9, p < 0.001), and fewer women required analgesics in the mechanical ripening group (27.5% versus 35.4%, difference in proportion -7.9%, 95% CI -13.2% to -2.7%, p = 0.003). There were no statistically significant differences between the 2 groups for other delivery, maternal, and neonatal outcomes. A limitation was a low observed rate of cesarean section. CONCLUSIONS: In this study, we observed no difference in the rates of cesarean deliveries for nonreassuring fetal status between mechanical ripening with a silicone double balloon catheter and pharmacological cervical ripening with a pessary for the slow release of dinoprostone. TRIAL REGISTRATION: ClinicalTrials.gov NCT02907060.

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.

Aspiration technique-based device is more reliable in cervical stiffness assessment than digital palpation.

BACKGROUND: The purpose of this study was to compare the reliability and reproducibility of the traditional qualitative method of assessing uterine cervical stiffness with those of a quantitative method using a novel device based on the aspiration technique. METHODS: Five silicone models of the uterine cervix were created and used to simulate different cervical stiffnesses throughout gestation. The stiffness of the five cervix models was assessed both by digital palpation (firm, medium and soft) and with the Pregnolia System. Five self-trained participants conducted the device-based assessment, whereas 63 obstetricians and midwives, trained in digital palpation, conducted the cervical palpation. RESULTS: The results of the two methods were analyzed in terms of inter-and intra-observer variability. For digital palpation, there was no common agreement on the assessment of the stiffness, except for the softest cervix. When assessing the same cervix model for a second time, 76% of the obstetricians and midwives disagreed with their previous assessment. In contrast, the maximum standard deviation for the device-based stiffness assessment for intra- and inter-observer variability was 3% and 3.4%, respectively. CONCLUSIONS: This study has shown that a device based on the aspiration technique provides obstetricians and midwives with a method for objectively and repeatably assess uterine cervical stiffness, which can eliminate the need to rely solely on a subjective interpretation, as is the case with digital palpation.

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.

Prognostic Factors of Successful Cervical Ripening and Labor Induction in Late-Onset Fetal Growth Restriction.

OBJECTIVE: The aim of this work was to identify independent risk factors influencing the achievement of vaginal delivery among women undergoing labor induction for late-onset fetal growth restriction (FGR). METHODS: This was a retrospective cohort study of 201 singleton pregnancies with late-onset FGR (diagnosed >32 + 0 weeks) that required labor induction with cervical ripening from 37 + 0 weeks, either with dinoprostone (from 2014 to 2015) or Foley balloon (from 2016 to 2018). Independent factors for successful vaginal delivery were identified. A prediction model of vaginal delivery with the identified factors was made using logistic regression and bootstrapping with 1,000 re-samples performed for bias correction. RESULTS: Perinatal results were more favorable in the vaginal delivery group, with significantly lower neonatal admission rates (4.0 vs. 13.7%) and lower composite neonatal morbidity (4.0 vs. 15.7%). The labor induction method (Foley balloon), higher cerebro-placental ratio, lower pre-gestational BMI, and absence of pre-eclampsia were identified as independent factors associated to vaginal delivery. The area under the curve of the model was of 0.75 (95% CI 0.70-0.79). CONCLUSIONS: The use of a Foley balloon is the only modifiable risk factor to improve the chances of vaginal delivery when attempting induction of labor in singleton pregnancies with late-onset FGR.

Comparison of effectiveness and safety of cervical ripening methods for induction of labour: A population-based study using coarsened exact matching.

BACKGROUND: There is no consensus about the ideal cervical ripening method to use for induction of labour. OBJECTIVE: To compare in current practice the effectiveness and safety of four cervical ripening methods. METHODS: We performed a matched comparative study using data from the MEDIP prospective population-based cohort conducted during one month in 2015 in all maternity units of seven French perinatal networks (3042 consecutive women with a live fetus and induction of labour). We analysed 1671 women with singleton cephalic fetus, unscarred uterus, and bishop score <7. Dinoprostone vaginal pessary (reference) was compared to dinoprostone vaginal gel, misoprostol vaginal tablet, and balloon catheter. Effectiveness outcomes were the need for more than one induction agent, oxytocin use, failure to achieve vaginal delivery within 24 hours (VD < 24 hours), and caesarean delivery. Safety outcomes were meconium-stained amniotic fluid, uterine hyperstimulation, NICU admission, and post-partum haemorrhage. Coarsened exact matching was used to balance confounders among the groups. Outcomes were compared using multivariable logistic regression models. RESULTS: Compared to the dinoprostone pessary (N = 1142, 68.3%), dinoprostone gel (N = 335, 20.1%) was associated with less failure to achieve VD < 24 hours (adjusted OR 0.66, 95% CI 0.47, 0.91). Misoprostol (N = 103, 6.2%) was associated with less need of more than one induction agent (aOR 0.56, 95% CI 0.34, 0.92) and less oxytocin use (aOR 0.60, 95% CI 0.37, 0.99). The balloon catheter (N = 91, 5.4%) was associated with more failure to achieve VD < 24 hours (aOR 2.62, 95% CI 1.37, 5.01), more caesarean delivery (aOR 1.84, 95% CI 1.09, 3.08), and less meconium-stained amniotic fluid (aOR 0.12, 95% CI 0.02, 0.70). Uterine hyperstimulation rates seemed lower with the balloon catheter (1.2% vs 4.2% for the pessary). CONCLUSIONS: In current practice, no cervical ripening method appears clearly superior to the others considering all effectiveness and safety outcomes.

Double- versus single-balloon catheters for labour induction and cervical ripening: a meta-analysis.

BACKGROUND: The induction of labour is an increasingly common procedure in the obstetrics field. Various methods have been used to induce labour, among which balloon catheters play an important role. Whether the specifically designed double-balloon catheter is better than the single-balloon device in terms of efficacy, efficiency, safety and patient satisfaction remains controversial. Identifying even small differences between these two devices could be useful to guide clinical practices, to further explore their mechanisms, and to promote a better understanding of the optimal methods for inducing labour. METHODS: Using the population, intervention, comparison, outcomes and study designs (PICOS) principle, we searched the PubMed, EMBASE, OVID, SCI, CENTRAL, ClinicalTrial.gov , and CDSR databases to identify relevant randomised controlled trials (RCTs) from inception through February 14, 2018. The primary outcome was the caesarean delivery rate, and the secondary outcomes focused on efficacy, efficiency, safety, and patient satisfaction. The relative risks or mean differences, including their 95% confidence intervals, were calculated using fixed-effects or random-effects models. All statistical analyses were completed with RevMan version 5.3. RESULTS: From a total of 1326 articles, 7 RCTs involving 1159 women were included. There were no significant differences in primary outcomes (RR, 0.88 [0.65, 1.2]; p-value, 0.43) or secondary outcomes identified between single- and double-balloon catheters. However, heterogeneity existed for some aspects. CONCLUSION: Both kinds of balloon catheter have similar levels of efficacy, efficiency, safety and patient satisfaction; however, the single-balloon method is considered to be more cost-effective.

Minimally Invasive Treatment of Cesarean Scar and Cervical Pregnancies Using a Cervical Ripening Double Balloon Catheter: Expanding the Clinical Series.

The efficacy of treating cesarean scar pregnancies and cervical pregnancies with the Cook® cervical ripening balloon catheter, in a multicenter office-based setting is reported. Thirty-eight women were treated. Insertion of the catheter was performed under real-time ultrasound guidance. Patients received adjuvant systemic methotrexate, prophylactic oral antibiotics, and oral pain medication. Serum human chorionic gonadotropin and ultrasound scans were followed serially until resolution. Thirty-seven patients were successfully treated, requiring no further procedures. We found that the Cook cervical ripening balloon technique is a simple, effective, outpatient, minimally invasive treatment with few complications noted in this expanded series.

In Vivo Measurement of Cervical Elasticity on Pregnant Women by Torsional Wave Technique: A Preliminary Study.

A torsional wave (TW) sensor prototype was employed to quantify stiffness of the cervix in pregnant women. A cross-sectional study in a total of 18 women between 16 weeks and 35 weeks + 5 days of gestation was performed. The potential of TW technique to assess cervical ripening was evaluated by the measurement of stiffness related to gestational age and cervical length. Statistically significant correlations were found between cervical stiffness and gestational age ( R 2 = 0.370 , p = 0.0074 , using 1 kHz waves and R 2 = 0.445 , p = 0.0250 , using 1.5 kHz waves). A uniform decrease in stiffness of the cervical tissue was confirmed to happen during the complete gestation. There was no significant correlation between stiffness and cervical length. A stronger association between gestational age and cervical stiffness was found compared to gestational age and cervical length correlation. As a conclusion, TW technique is a feasible approach to objectively quantify the decrease of cervical stiffness related to gestational age. Further research is required to evaluate the application of TW technique in obstetric evaluations, such as prediction of preterm delivery and labor induction failure.

Distinct reorganization of collagen architecture in lipopolysaccharide-mediated premature cervical remodeling.

Previous work has identified divergent mechanisms by which cervical remodeling is achieved in preterm birth (PTB) induced by hormone withdrawal (mifepristone) or lipopolysaccharide (LPS). Our current study aims to document how collagen architecture is modified to achieve premature cervical remodeling in mice treated with LPS as a model of infection-induced inflammation. Cervices were collected on gestation day (d) 15 from mice with premature cervical ripening induced by LPS and compared to d15 and d18 controls as well as a hormone withdrawal PTB model. Second harmonic generation (SHG) and electron microscopy were utilized for visualization of collagen morphology and ultrastructure. LPS-mediated premature cervical ripening is characterized by unique structural changes in collagen fiber morphology. LPS treatment increased the interfibrillar spacing of collagen fibrils. A preferential disruption of collagen fiber architecture in the subepithelial region compared to midstroma region was evidenced by increased pores lacking collagen signal in SHG images in the LPS-treated mice. Coinciding with this alteration, the infiltration of neutrophils was concentrated in the subepithelial stromal region as compared to midstromal region implicating the potential role of immune cells to extracellular matrix reorganization in inflammation-induced preterm cervical ripening. The current study demonstrates a preferential disorganization of collagen interfibrillar spacing and collagen fiber structure in LPS-mediated ripening.

Effect of extra-amniotic Foley's catheter and vaginal misoprostol versus vaginal misoprostol alone on cervical ripening and induction of labor in Kenya, a randomized controlled trial.

BACKGROUND: The safest, most effective and fastest combined approaches to induction of labor is unknown. In an open-label randomized clinical trial we evaluated the efficacy of combination of extra-amniotic Foley's catheter and vaginal misoprostol compared to vaginal misoprostol alone for cervical ripening and induction of labor on the incidence of failed induction, induction-to-delivery interval and adverse maternal and perinatal outcomes. METHODS: Pregnant women at gestational age of 28 weeks or greater admitted at Kenyatta National Hospital, Kenya for induction of labor were enrolled then randomized to either a combination of extra-amniotic Foley's catheter inflated by 30 cm3 of normal saline and 25 micrograms of vaginal misoprostol or 25 micrograms of vaginal misoprostol alone. Women underwent 6 hourly reviews and additional misoprostol inserted if required. The primary outcome was incidence of failed induction. Secondary outcomes were induction-to-delivery interval and adverse maternal and perinatal outcomes. We conducted an intent-to-treat analysis and compared means or medians using t-test or Wilcoxon rank, proportions using Chi-square or Fishers test as appropriate. Induction-to-delivery interval were compared using the log-rank test. P-values of < 0.05 and 95% confidence intervals that excluded the null were considered statistically significant. RESULTS: Between February and May 2016, we enrolled 180 of 237 pregnant women admitted for induction of labor and randomized them to either a combination of extra-amniotic Foley's catheter and vaginal misoprostol (n = 90) or vaginal misoprostol alone (n = 90). The socio-demographic and obstetric characteristics were similar between the two groups. Failed induction rates were lower but not statistically significant following combined extra-amniotic Foley's catheter and vaginal misoprostol (8.9%) versus vaginal misoprostol alone (11.1%). The mean induction-to-delivery time was 4.8 h shorter in the combined extra-amniotic Foley's catheter and vaginal misoprostol (mean 18.9, standard deviation (SD) 7.2 h) compared to misoprostol only group (mean 14.1, SD 6.9 h) (log-rank test, p < 0.001). Maternal and perinatal complications were similar between the two groups. CONCLUSIONS: Extra-amniotic Foley's catheter and vaginal misoprostol for cervical ripening and induction of labor did not significantly lower the incidence of failed induction but safely shortened induction-to-delivery time compared to vaginal misoprostol only. TRIAL REGISTRATION: Trial was retrospectively registered on 14-03-2016 PACTR201604001535825.

Comparison of effacement curve with dilatation curve for prediction of labor progression.

AIM: This study was conducted to evaluate the ability of the effacement curve to predict fetal descent by comparing it to dilatation in order to improve the accuracy of the current partogram. METHOD: We conducted an observational study of women who were admitted for vaginal delivery at Mobini Hospital, Sabzevar, Iran in 2015. During labor, dilatation and effacement were plotted in different graphs and then their association with fetal descent was separately evaluated and compared. This assessment was performed in two groups: primipara and multipara. RESULTS: From 1750 individuals, 503 primiparous and 512 multiparous women were eligible for the study. An adjusted generalized estimating equations multivariable model showed both dilatation and effacement had a significant relationship with fetal descent either in primipara or multipara. In primipara, the prediction value of effacement equalled dilatation (ß,eff 0.29, P < 0.001; ß,dil 0.30, P < 0.001). In multipara, the prediction value of effacement was obviously higher than dilatation (ß,eff 0.45, P < 0.001; ß,dil 0.27, P < 0.001). The strength of effacement to predict labor in multipara was clearly greater than in primipara (ß,eff 0.45 and ß,eff 0.29, respectively). The strength of dilatation to predict labor in multipara was comparable to primipara (ß,dil 0.27 and ß,dil: 0.30, respectively). CONCLUSIONS: Regarding the acceptable predictive value of effacement, we believe considering effacement, dilatation and station curves altogether can improve the power of the existing partogram for the assessment of labor progression and detection of failure to progress.

Outpatient cervical ripening in a district general hospital: a five-year retrospective cohort study.

The number of women undergoing induction of labour has risen steadily in recent years. Outpatient induction is becoming more common in the UK in response to the required increase in resources, although evidence supporting its safety is lacking. We reviewed the notes of low-risk women presenting for outpatient cervical ripening using prostaglandins over a five-year period, and compared our neonatal and maternal outcomes to local and national data. Of the 502 eligible women, 400 underwent outpatient treatment. Most women returned early, in labour. There were no foetal, neonatal or maternal deaths, and our neonatal morbidity compared favourably with local rates. Mode of delivery and major maternal complication rates were comparable to national maternity indicators. We conclude that outpatient cervical ripening following careful case selection does not appear to increase neonatal or maternal mortality or morbidity. It offers patients an alternative to traditional inpatient induction and may improve allocation of hospital resources. Impact statement We present a retrospective cohort study of neonatal and maternal outcomes in 502 women selected for outpatient cervical ripening for postmaturity at Bedford Hospital over the five-year period from 2010 to 2015. This study was conceived following a previous publication in this journal from Bedford Hospital in 2002 by Neale et al., which described the outcomes of 100 women who underwent outpatient cervical ripening. Our conclusions compare the results from the two studies. Out of our combined sample of 602 women, 491 were discharged home following administration of prostaglandins. This represents the largest sample size in the published literature on outpatient induction of labour, which was first undertaken in our unit in 1998 and is now widely practiced within the UK. Several publications, including the 2013 Cochrane review by Kelly et al. and a recent large survey of practice (Sharp et al. 2016 ) have highlighted the paucity of available data regarding the safety of this procedure as an outpatient. We therefore hope that the results of our study will be of interest to many maternity units who currently undertake or are considering to provide the facility for outpatient cervical ripening as a prelude to induction of labour.

Tachysystole Following Cervical Ripening and Induction of Labor Is Not Associated with Adverse Outcomes.

PURPOSE: This study was aimed at determining if significant uterine tachysystole was associated with adverse fetal or neonatal outcomes during cervical ripening and induction of labor. METHODS: Women undergoing cervical ripening and subsequent labor induction (n = 905) were assessed for tachysystole, defined as ≥6 contractions in each of 2 consecutive 10-minute windows. Women with ≥3 episodes of tachysystole were compared to women with no tachysystole. RESULTS: Over a 5-year period, 70% of the 905 participants (n = 631) had no tachysystole, 143 had 1 or 2 episodes whereas 131 or 15% had ≥3 episodes (p = 0.991). The cesarean delivery rate was lower among those with tachysystole (28.2 vs. 34.1%), but the difference was not significant (p = 0.197). Non-reassuring fetal tracings were more common in the tachysystole group (14.4 vs. 21.4%, p = 0.017), but the Apgar scores at 5 min and the umbilical cord pH and base excess were similar between the 2 groups (p = 0.502, p = 0.435, and p = 0.535, respectively). CONCLUSIONS: Tachysystole was not associated with adverse perinatal outcomes when compared to women with no tachysystole during cervical ripening and induction of labor.

Can we predict successful cervical ripening with prostaglandin E2 vaginal inserts?

PURPOSE: Previous studies have suggested that a variety of maternal and obstetrical characteristics may predict successful prostaglandin E2 (PGE2) cervical ripening. However, in most studies women were administered vaginal tablets or gel so scarce is known regarding potential predictors in women administrated slow-release vaginal inserts. We aimed to characterize the response of cervical ripening for labor induction using slow-release PGE2 vaginal insert and to identify predictors for success. METHODS: A retrospective cohort study in a single center (2013-2015). The association between maternal characteristics at admission and cervical ripening success/failure were explored. Cervical ripening failure was defined as a Bishop's score <7 following 24 h from cervical ripening or the need for cesarean delivery (CS) due to arrest of dilatation at cervical dilatation ≤5 cm. Cases with major fetal anomalies, multiple gestations, non-vertex presentation or any contraindication for vaginal delivery were excluded. RESULTS: Of 15,564 deliveries during the study period, 986 (6.3%) women met inclusion criteria, of them, 774 (78.56%) succeeded and 212 (21.5%) failed cervical ripening. Cervical ripening success was associated with (OR, 95% CI): nulliparity (0.42, 0.22-0.81, p = 0.009, i.e., nulliparity was negatively associated with successful ripening), gestational age (GA) at delivery (1.29, 1.02-1.61, p < 0.03), and cervical dilation at admission (4.58, 2.57-8.17, p < 0.001). The indications for labor induction were not associated with cervical ripening success. A prediction model which included the abovementioned characteristics had an AUC of 0.792 (95% CI 0.743-0.840). CONCLUSIONS: Overall, basic parameters, such as parity, cervical dilatation at admission and gestational age can predict successful cervical ripening PGE2 vaginal inserts.

Double-balloon catheter for induction of labour in women with a previous cesarean section, could it be the best choice?

INTRODUCTION: We analysed the efficacy and safety of double-balloon catheter for cervical ripening in women with a previous cesarean section and which were the most important variables associated with an increased risk of repeated cesarean delivery. MATERIALS AND METHODS: We designed an observational retrospective study of 418 women with unfavourable cervices (Bishop Score <5), a prior cesarean delivery, and induction of labour with a double-balloon catheter. Baseline maternal data and perinatal outcomes were recorded for a descriptive, bivariate, and multivariate analysis. A p value <0.05 was considered statistically significant. RESULTS: Most women improved their initial Bishop Score (89.5%) although only a 20.8% of them went into spontaneous active labour. Finally, 51.4% of the women achieved a vaginal delivery. Five cases of intrapartum uterine rupture (1.2%) occurred. After multivariate analysis, main risk factors for repeated cesarean section were dystocia in the previous pregnancy (OR 1.744; CI 95% 1.066-2.846), the absence of previous vaginal delivery (OR 2.590; CI 95% 1.066-6.290), suspected fetal macrosomia (OR 2.410; CI 95% 0.959-6.054), and duration of oxytocin induction period (OR 1.005; CI 95% 1.004-1.006). The area under the curve was 0.789 (p < 0.001). CONCLUSIONS: Double-balloon catheter seems to be safe and effective for cervical ripening in women with a previous cesarean delivery and unfavourable cervix. In our study, most women could have a vaginal delivery in spite of their risk factors for cesarean delivery. A multivariate model based on some clinical variables has moderate predictive value for intrapartum cesarean section.