Cervical Ripening In Women Research Articles

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

Background and problemTo 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. MethodsThis 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. Findings180 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). ConclusionVaginal 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.

470 Double-balloon cervical ripening in women with scarred uterus presenting with PROM: A randomized controlled trial

470 Double-balloon cervical ripening in women with scarred uterus presenting with PROM: A randomized controlled trial

Synthetic Osmotic Dilators for Pre-Induction Cervical Ripening - an Evidence-Based Review.

Mechanical methods have gained growing interest for pre-induction cervical ripening in women with an unripe cervix, since they have a better safety profile compared to prostaglandins. Balloon catheters have been the gold standard method for decades, while there was a lack of data on synthetic osmotic cervical dilators. Not until 2015, when Dilapan-S was approved by the Food and Drug Administration (FDA) for induction of labor, numerous studies have been published on the use of Dilapan-S in this field. The rate of vaginal deliveries associated with the use of Dilapan-S ranges from 61.6 to 81.7%, and no serious complications needing further interventions have been reported to this date. Dilapan-S was shown to be as effective as the Foley balloon catheter as well as the 10mg PGE 2 vaginal insert and orally applied misoprostol (25µg every 2 hours) in achieving vaginal delivery, but patient's satisfaction during the cervical ripening process was significantly higher compared to the other methods and the rate of uterine hyperstimulation was significantly lower compared to prostaglandins (PGs). Minor complications (e.g. vaginal bleeding) associated with the use of Dilapan-S were <2%, and maternal infectious morbidity was not higher compared to Foley balloon and vaginal PGE 2 or misoprostol. Due to these beneficial properties Dilapan-S might be an ideal option for outpatient cervical ripening, as shown in a recent randomized clinical trial comparing inpatient to outpatient cervical ripening. Furthermore, according to the manufacturers' product information, Dilapan-S is the only cervical ripening method that is not contraindicated for induction of labor in women with a previous cesarean section. Upcoming guidelines should consider synthetic osmotic cervical dilators as an effective and safe method for cervical ripening/induction of labor acknowledging that more evidence-based data are mandatory, particularly in patients with a previous cesarean section.

Prediction of an effective cervical ripenning in the induction of labour using vaginal dinoprostone

To develop a predictive model for successful cervical ripening in women that undergo induction of labour by means of a vaginal prostaglandin slow-release delivery system (Propess®). Prospective observational study on 204 women that required induction of labour between February 2019 and May 2020 at “La Mancha Centro” hospital in Alcázar de San Juan, Spain. The main variable studied was effective cervical ripening (Bishop score > 6). Using multivariate analysis and binary logistic regression, we created three initial predictive models (model A: Bishop Score + Ultrasound cervical length + clinical variables (estimated fetal weight, premature rupture of membranes and body mass index)); model B: Ultrasound cervical lenght + clinical variables; and model C: Bishop score + clinical variables) to predict effective cervical ripening. All three predictive models obtained (A, B and C) presented good predictive capabilities, with an area under the ROC curve ≥ 0.76. Predictive model C, composed of the variables: gestational age (OR 1.55, 95% CI 1.18–2.03, p = 0.002), premature rupture of membranes (OR 3.21 95% CI 1.34–7.70, p = 0.09) body mass index (OR 0.93, 95% CI 0.87–0.98, p = 0.012), estimated fetal weight (OR 0.99, 95% CI 0.99–1.00, p = 0.068) and Bishop score (OR 1.49 95% CI 1.18–1.81, p = 0.001), is presented as the model of choice with an area under the ROC curve of 0.76 (95% CI 0.70–0.83, p < 0.001). A predictive model composed of the variables: gestational age, premature rupture of membranes, body mass index, estimated fetal weight and Bishop score upon admission presents good capabilities in predicting successful cervical ripening following administration of prostaglandins. This tool could be useful in making clinical decisions with regard to induction of labour.

Dinoprostone Vaginal Insert vs Intracervical Foley Catheter for Preinduction Cervical Ripening in Women with Previous Cesarean Section

Dinoprostone Vaginal Insert vs Intracervical Foley Catheter for Preinduction Cervical Ripening in Women with Previous Cesarean Section

An assessment of cervical ripening with evening primrose oil: An obstetrical review

Objective: To compare cervical ripening in women having evening primrose oil with those not taking it. Study Design: Retrospective Cohort study. Setting: Department of Obs &amp; Gynae, Abbasi Shaheed Hospital, Karachi. Period: July 2018 to April 2021. Material &amp; Method: Patients were divided into 2 groups, one having evening primrose oil (EPO) 1gm twice daily from 37 weeks till labor, given by her previous birth attendant. Another group was without using evening primrose oil. Both were examined for cervical ripening by bishop score, length of labour and then for need for cesarean section. Statistical plan: SPSS 20. Results: BISHOP score for EPO group (6.1) vs non-EPO group (4.3) was statistically significant (p-value &lt; 0.001). EPO have soft cervical consistency (73.5%), followed by medium (10.2%) and firm (16.3%) while non EPO have firm consistency (41.2%) followed by soft (37.3%) and medium (21.6%). The differences was statistically significant (p-value=0.001). The average length of labor for EPO group was 7.7 hours (±2.5 SD) and Non-EPO was 8.4 hours (±2.4 SD), statistically insignificant. The mode of delivery wasn’t statistically significantly different between two groups. Conclusion: EPO tend to have soft cervical consistency. However mode of delivery between EPO group and Non-EPO group did not have any significant difference.

Evening primrose oil for cervical ripening prior to labor induction in post-term pregnancies: A randomized controlled trial

Cervical ripening can be induced using a variety of methods. It is used in cases where the cervix is in an unfavorable state prior to the start of the labor induction. The purpose of this study was to investigate how vaginal administration of evening primrose oil (EPO) affects cervical ripening in women who were scheduled for labor induction. This randomized controlled trial was conducted from November 2018 to December 2019. The inclusion criteria were as follows: age 18-35 years old, first pregnancy, a live singleton baby with a cephalic presentation, gestational age≥ 41 weeks, intact membranes, normal cardiotocography, and a Bishop score of ≤ 4. Two hundred women were randomly assigned to a single vaginal dose of 1000 mg evening primrose oil (n=100) or placebo (n=100). Any change in Bishop score was considered the primary outcome variable in the efficacy evaluation. Of 200 eligible women, 25 women were excluded for various reasons. Finally, statistical analysis was performed on 175 women (88 women in the experimental group and 87 in the control group). At baseline there was no significant difference between the two groups in Bishop score. However, after the intervention, this score was significantly higher in the experimental group than in the control group (Mean Difference: 3.29, 95% Confidence Interval: 3.51 to 1.18). No adverse effects were observed or reported. Vaginal application of EPO at a single dose of 1000 mg at 41 weeks gestation improved Bishop score and reduced parturition time in post-term pregnancies. Iranian Registry of Clinical Trials (IRCT20181107041585N3).

Optimizing cervical ripening in women presenting with decreased fetal movements

Objective To determine the optimal method for cervical ripening in women presenting with decreased fetal movements at term. We hypothesized that women who undergo induction of labor for decreased fetal movements represent a higher risk group, and will benefit from mechanical intervention with cervical ripening balloon rather than with pharmacological prostaglandin E2 vaginal insert. Study design Retrospective cohort study from January 2014 and January 2019. We recommended induction of labor to every woman ≥39 weeks’ gestation with complaints of persistent decreased fetal movements. We excluded women with major fetal anomalies, Bishop score of ≥6 on admission, and cases with contraindications to prostaglandins. Women were allocated into one of two groups based on the cervical ripening agent used. In group 1 we introduced the prostaglandin E2 vaginal insert (10 mg dinoprostone in a timed-release formulation). In group 2 we placed the mechanical cervical ripening balloon. The primary outcome of the study, analyzed separately to nulliparous and multiparous women, was the rate of cesarean delivery in each of the groups. Results During the 5-years study, 294 women were included in the final analysis, of which 201 were in the prostaglandin E2 vaginal insert group and 93 were in the cervical ripening balloon group. The rate of cesarean delivery was comparable between the groups (nulliparous: 20.8%, 16/77 versus 21.3%, 10/47. multiparous: 16.9%, 21/124 versus 7%, 3/46, respectively). Other maternal and neonatal secondary outcomes, including the induction-to-delivery time (nulliparous: 32.5 ± 25.3 h versus 26.5 ± 12.2 h. multiparous: 24.6 ± 17.2 h versus 21.25 ± 12.3 h, respectively), were also not different between the two induction methods used. A longer induction-to-delivery time was observed in nulliparous women who had repeat prostaglandin E2 vaginal insert compared with the cervical ripening balloon group (74.6 ± 27.3 h versus 26.5 ± 12.2 h, p < .01). Conclusion Both pharmacological and mechanical methods can safely and efficiently be used for cervical ripening in women presenting with decreased fetal movements at term. With repeat prostaglandin E2 use, nulliparous women may experience a prolong labor compared with the cervical ripening balloon group, but maternal or fetal safety are not compromised.

Efficacy and safety of oral misoprostol vs transvaginal balloon catheter for labor induction: An observational study within the SWEdish Postterm Induction Study (SWEPIS).

Induction of labor is increasing. A common indication for induction of labor is late term and postterm pregnancy at 41 weeks or more. We aimed to evaluate if there are any differences regarding efficacy, safety, and women's childbirth experience between oral misoprostol and transvaginal balloon catheter for cervical ripening in women with a low-risk singleton pregnancy and induction of labor at 41+0 to 42+0 to 1 weeks of gestation. In this observational study, based on data from the Swedish Postterm Induction Study (SWEPIS), a multicenter randomized controlled trial, a total of 1213 women with a low-risk singleton pregnancy at 41 to 42 weeks of gestation were induced with oral misoprostol (n=744) or transvaginal balloon catheter (n=469) at 15 Swedish delivery hospitals. The primary efficacy outcome was vaginal delivery within 24h and primary safety outcomes were neonatal and maternal composite adverse outcomes. Secondary outcomes included time to vaginal delivery and mode of delivery. Women's childbirth experience was assessed with the Childbirth Experience Questionnaire (CEQ 2.0) and visual analog scale. We present crude and adjusted mean differences and relative risks (RR) with 95% CI. Adjustment was performed for a propensity score based on delivery hospital and baseline characteristics including Bishop score. Vaginal delivery within 24h was significantly lower in the misoprostol group compared with the balloon catheter group (46.5% [346/744] vs 62.7% [294/469]; adjusted RR 0.76 95% CI 0.640.89]). Primary neonatal and maternal safety outcomes did not differ between groups (neonatal composite 3.5% [36/744] vs 3.2% [15/469]; adjusted RR 0.77 [95% CI 0.31-1.89]; maternal composite 2.3% [17/744] vs 1.9% [9/469]; adjusted RR 1.70 [95% CI 0.58-4.97]). Adjusted mean time to vaginal delivery was increased by 3.8h (95% CI 1.3-6.2h) in the misoprostol group. Non-operative vaginal delivery and cesarean delivery rates did not differ. Women's childbirth experience was positive overall and similar in both groups. Induction of labor with oral misoprostol compared with a transvaginal balloon catheter was associated with a lower probability of vaginal delivery within 24h and a longer time to vaginal delivery. However, primary safety outcomes, non-operative vaginal delivery, and women's childbirth experience were similar in both groups. Therefore, both methods can be recommended in women with low-risk postdate pregnancies.

891 Use of misoprostol for labor induction among women with fetal growth restriction

To determine whether vaginal misoprostol use among women with fetal growth restriction (FGR) for induction of labor (IOL) was associated with cesarean delivery (CD) or neonatal morbidity. This was a secondary analysis of a prospective cohort study of women undergoing IOL at one institution from July 2017-July 2019. Women were included if they were undergoing IOL at ≥37 weeks with intact membranes and an unfavorable cervix (Bishop score of ≤6 and cervical dilation ≤2cm). Women with a prior CD or estimated fetal weight (EFW)<3rd percentile with abnormal umbilical artery dopplers were excluded. FGR was defined as EFW <10th percentile. Our exposed group was those who received any misoprostol during IOL (alone or in combination with cervical Foley); unexposed were those who did not receive misoprostol. Choice of induction agents were at provider discretion. There were 1,610 women in the entire cohort; 419 had known FGR and were included. There was no difference in CD risk among those who received misoprostol versus those who did not (25.3% vs 22.9% p=0.72), even when controlling for confounders including parity, bishop score, and body mass index, (aOR 0.75, 95% CI 0.34-1.67). Among all CDs, the rate of CD for non-reassuring fetal heart tones (NRFHT) was also not significantly different between groups (misoprostol 56% vs no misoprostol 55%, p=0.91). Notably, the rate of neonatal 5 minute Apgar score <7 was lower among those who received misoprostol compared to those who did not (1.3% vs. 6.2%, p=0.02). Neonatal intensive care unit admission >48 hours was also lower among those who received misoprostol, though this did not reach statistical significance (3.2% vs 6.2%, p=0.13). When restricted to those with FGR<5th percentile, results were unchanged. In this large prospective cohort of women with FGR undergoing term IOL, misoprostol exposure did not increase CD risk overall, CD for NRFHT, or neonatal morbidity. These findings provide reassurance that misoprostol can be used safely for cervical ripening in women with FGR.

Pre-Induction Cervical Ripening Using a Transcervical Foley Catheter Combined with ISMN Vaginal Tablets for Vaginal Birth after Previous Caesarean Section (VBAC)—A Comparative Study

Objective: To compare the effectiveness, safety and client acceptability of concurrent application of transcervical Foley catheter with vaginal ISMN-sustained release (SR) 60 mg tablet versus transcervical Foley catheter alone for pre-induction cervical ripening in women who are undergoing Vaginal birth after C-section (VBAC). Method: A prospective single blind randomized control study was carried out including 110 pregnant women who had unfavorable cervix (MBS less than 6) at 40 weeks and 3 days of gestation. The two groups received either the trans-cervical foley catheter with a vaginal ISMN 60 mg sustained release (SR) tablet on 40 weeks and 3 days (Treatment arm 1, n = 57), or trans-cervical Foley alone on 40 weeks and 3 days (Treatment arm 2, n = 53). Results: At 40 weeks + 3 days gestation, the mean age, mean parity and the mean modified Bishop Score (MBS) were comparable among the two treatment groups. Majority (n = 98, 89.1%) remained without spontaneously establishing labour at 24 hours of intervention. The difference in mean MBS at 40 weeks + 4 days (24-hours following the intervention) in the two groups was statistically not significant (P > 0.05). The group who received concurrent ISMN vaginal tablets achieved a higher number of successful VBACs (n = 33, 62.3%) over the group who received the Foley catheter only method (n = 29, 50.9%), however, not statistically significant (P > 0.05). Conclusions: The concurrent use of vaginal ISMN tablets (60 mg SR) with a transcervical Foley catheter failed to show higher effectiveness compared to a transcervical Foley catheter alone as an induction method.

Evaluating the efficacy of outpatient use of isosorbide mononitrate on cervical ripening in pregnant women with unfavourable cervix

The aim of the present study was to evaluate the efficacy of outpatient administration of nitric oxide donor isosorbide mononitrate for cervical ripening. A randomised clinical trial was performed on term pregnant women with Bishop Score < 6. In the case group, Isosorbide-5-mononitrate capsule and in the control group, placebo was inserted in the posterior vaginal fornix for two consecutive days. The main outcomes were increases in Bishop Score after 48 hours of intervention, number of vaginal deliveries and interval from intervention to delivery. There was a significant increase of the mean Bishop score in the isosorbide group [3.57 ± 1.12 VS 1.54 ± 1.42 respectively (p = .001)]. The other outcome variables did not show a significant difference between the two groups except for headache which was significantly more in the case group. No cases of tachysystole were observed in the two groups. Additionally, haemoglobin levels after delivery did not show a significant difference between the two groups. Impact statement: What is already known on this subject? Cervical ripening in women with an unfavourable cervix and having an indication for induction of labour is an important issue in modern obstetrics. Different methods have been used for cervical ripening and induction of labour including mechanical (i.e. laminaria tents, Dilapan-S, foley catheter), medical (i.e. PGs) and supportive methods. There is no consensus on the best option for cervical ripening What will the results of this study add to the current knowledge of this subject? Outpatient administration of nitric oxide could affect cervical ripening without a significant improvement in the duration of different stages of labour, intervention to delivery interval and number of vaginal deliveries. What are the implications of these findings for clinical practice and/or further research? Due to the contradictory results of various studies, more studies should be performed with greater sample size to evaluate nitric oxide donor isosorbide mononitrate effect on labour duration and reducing caesarean deliveries. Additional data is needed to assess the real impact of NO donors on different stages of labour and its implications.

Morbidity associated with the use of Foley balloon for cervical ripening in women with prior cesarean delivery

Objective We evaluated the morbidity of Foley balloon for cervical ripening in comparison to oxytocin alone in women with a prior cesarean delivery. Study design A four-hospital retrospective review of all women with viable singleton pregnancies and history of a single prior cesarean delivery presenting for cervical ripening between 1994 and 2015. Exposure groups were either Foley balloon or oxytocin, at the treating physician’s discretion. The primary outcome was defined as maternal morbidity, evaluated by a composite that included hemorrhage, and/or uterine infection, and/or uterine rupture. We defined two secondary outcomes: neonatal morbidity, and vaginal delivery rate. Neonatal morbidity was evaluated by a composite that included five-minute APGAR score <7 and/or NICU admission. We adjusted results for potential confounding variables, including hospital site, maternal age and race, initial cervical dilation, and gestational age at delivery. Results We identified 688 patients who received ripening, 276 by Foley balloon and 412 by oxytocin. There was no significant difference in the primary outcome of maternal morbidity between groups: 38 (13.8%) in the Foley balloon group and 79 (19.2%) in the oxytocin group (aOR 1.43; 95% CI, 0.90–2.27). There was no significant difference in the secondary outcome of neonatal morbidity: 31 (11.3%) in the Foley balloon group and 51 (12.4%) in the oxytocin group (aOR 1.02; 95% CI, 0.57–1.80). The rate of vaginal delivery was significantly less in the Foley balloon group compared to the oxytocin group: 56.2% vs 64.1%, p = .037. Conclusion When cervical ripening with either Foley balloon or oxytocin was utilized at the physician’s discretion in women with prior cesarean, there was no identified difference in maternal and neonatal morbidity, but the rate of successful vaginal delivery was lower.

Rate of Cervical Change During Ripening in Nulliparous Women Using Vaginal or Buccal Misoprostol [38J

INTRODUCTION: Cervical ripening is frequently needed for labor induction in nulliparous women. The objective of this study was to determine if the rate of cervical change and time to active labor were different when misoprostol is administered by vaginal or buccal route. METHODS: This was a secondary analysis of nulliparous women enrolled in the IMPROVE Study- A comparison of vaginal versus buccal misoprostol for cervical ripening in women for labor induction at term: a triple-masked randomized controlled trial. Primary outcomes were time to active labor (defined as at least 6 cm cervical dilation) and rate of change of cervical dilation up to active labor. Survival analysis using Product-Limit Survival Estimate and Kaplan-Meier method was utilized for time to active labor. IRB approval was obtained. RESULTS: Of the 300 women enrolled in the trial, 124 (41.3%) were nulliparous, with 59 receiving vaginal misoprostol and 65 receiving buccal. Nulliparous women receiving vaginal dosing required fewer doses to reach active labor (2.0 vs 3.0, P=.003). However, this did not result in shorter time to active labor (median 23.1 hrs vs. 25.6, P=.49). The rate of cervical change for the vaginal misoprostol group from trial entry to ≥6 cm was 2.9 (±1.6) mm/hr compared to 2.9 (±1.6) mm/hr for buccal (P=.97). CONCLUSION: In nulliparous women undergoing cervical ripening with misoprostol, vaginal dosing may require fewer doses to achieve active labor but the time to active labor and rate of cervical change were similar between dosing groups. There may not be clinically meaningful differences between dosing routes in nulliparous women.

Balloon catheter use for cervical ripening in women with term pre-labor rupture of membranes: A 5-year cohort study.

To investigate the safety of balloon catheter for cervical ripening in women with term pre-labor rupture of membranes (PROM) and to compare the incidence of maternal and neonatal infections in women with PROM and women with intact membranes undergoing cervical ripening with a balloon catheter. This retrospective cohort study of 1923 women with term singleton pregnancy and an unfavorable cervix undergoing cervical ripening with a balloon catheter was conducted in Helsinki University Hospital between January 2014 and December 2018. For each case of PROM, two controls were assigned. The main outcome measures were the rates of maternal and neonatal infections. Statistical analyses were performed by SPSS. In all, 641 (33.3%) women following PROM and 1282 (66.6%) women with intact amniotic membranes underwent labor induction. The rates of intrapartum infection (3.7% vs 7.7%; P = .001) and neonatal infection (1.7% vs 3.8%; P = .01) were not increased in women induced by balloon catheter following PROM. Intrapartum infections were associated with nulliparity (odds ratio [OR] 3.3, 95% confidence interval [CI] 1.6-6.5), history of previous cesarean section (OR 2.8, 95% CI 1.2-6.4), extended gestational age ≥41 weeks (OR 1.9, 95% CI 1.2-3.0) and an induction to delivery interval of 48 hours or more (OR 2.0, 95% CI 1.2-3.3). The risk of neonatal infection was associated with nulliparity (OR 3.3, 95% CI 1.4-8.0), gestational age ≥41 weeks (OR 1.9, 95% CI 1.09-3.36) and induction to delivery interval of 48 hours or more (OR 3.4, 95% CI 1.9-6.0). Use of balloon catheter in women with term PROM appears safe and was not associated with increased maternal or neonatal infectious morbidity.

Sublingual Misoprostol versus Foley catheter for cervical ripening in women with preeclampsia or gestational hypertension: A randomized control trial.

BackgroundDelivery is the only definite cure for hypertensive disorders. Therefore, cervical ripening and labor induction are important to achieve favorable outcomes.Objective This Randomized Control Trial (RCT) is aimed to compare the effects of sublingual misoprostol and Foley catheter in cervical ripening and labor induction among patients with preeclampsia or gestational hypertension.Materials and MethodsA total number of 144 women with preeclampsia or gestational hypertention with indication of pregnancy termination, who were referred to academic hospitals of the University of Medical Sciences in Mashhad, Iran, between March 2015 and December 2016, were randomly divided into two groups. In group one (n = 72), 25 µg of misoprostol tablet was administrated sublingually every 4 hr up to six doses. In group two (n = 72), a 16F Foley catheter was placed through the internal cervical os, inflated with 60 cc of sterile saline.ResultsThere were no significant differences between groups regarding the demographic characteristics, primary bishop score, and pregnancy termination indication. The cervical ripening time (primary outcome) (8.2 vs 14.2 hr, p 0.00), induction to delivery interval (15.5 vs 19.9 hr, p 0.00), and vaginal delivery before 24 hr (63.9% vs 40%, p = 0.03) were significantly different between the two groups. There was no significant difference between groups in view of oxytocin requirement (p = 0.12), neonatal Apgar score (p = 0.84), or neonatal intensive care unit admission (p = 78).ConclusionThis trial showed that the application of sublingual misoprostol, compared to the Foley catheter, can reduce cervical ripening period and other parameters related to the duration of vaginal delivery. This misoprostol regimen showed inconsiderable maternal complications.

Increased Single-balloon Foley Catheter Volume for Induction of Labor and Time to Delivery: A Systematic Review and Meta-Analysis

(Acta Obstet Gynecol Scand. 2018;97:1051–1060) The Foley catheter is commonly used for cervical ripening in women undergoing labor induction. In an attempt to raise the Bishop score at a faster rate and decrease the time to delivery, Foley balloons are often overinflated, or balloons that accept larger volumes are used. This systematic review and meta-analysis examined randomized controlled trials to determine whether or not this practice is effective in decreasing the time between the start of labor induction and delivery.

Is Foley Catheter Use during a Trial of Labor after Cesarean Associated with Uterine Rupture?

We sought to assess the safety of transcervical Foley catheter (TCF) placement for cervical ripening in women undergoing induction of labor (IOL) after prior cesarean by evaluating the risk of uterine rupture. We performed a secondary analysis of the Maternal-Fetal Medicine Unit's Cesarean Section Registry, a prospective observational cohort study. We included women with a history of ≤2 low-transverse cesarean deliveries who underwent IOL at ≥24 weeks of gestational age with a live singleton fetus without major anomalies. We excluded those who received prostaglandins or laminaria. We performed multinomial logistic regression to calculate adjusted odds ratios (aORs) for uterine rupture and dehiscence. Relevant confounders included prior vaginal delivery, pregnancy-induced hypertension, chorioamnionitis, and cervical effacement and dilation on admission. A total of 2,564 women were eligible. Unadjusted analysis demonstrated no increased risk of uterine rupture with TCF (1.9 vs. 0.9%; p = 0.10) but an increased risk of uterine dehiscence (1.9 vs. 0.6%; p = 0.02). After adjustment, TCF was not associated with an increased risk of uterine rupture (aOR: 2.02; 95% confidence interval [CI]: 0.71-5.78) or uterine scar dehiscence (aOR: 1.32; 95% CI: 0.37-4.72). Foley catheter is a safe tool for mechanical dilation in women undergoing IOL after prior cesarean.

A comparison of vaginal versus buccal misoprostol for cervical ripening in women for labor induction at term (the IMPROVE trial): a triple-masked randomized controlled trial

Cervical ripening is commonly needed for labor induction. Finding an optimal route of misoprostol dosing for efficacy, safety, and patient satisfaction is important and not well studied for the buccal route. To compare the efficacy and safety of vaginal and buccal misoprostol for women undergoing labor induction at term. The IMPROVE trial was an institutional review board-approved, triple-masked, placebo-controlled randomized noninferiority trial for women undergoing labor induction at term with a Bishop score ≤6. Enrolled women received 25 mcg (first dose), then 50 mcg (subsequent doses) of misoprostol by assigned route (vaginal or buccal) and a matching placebo tablet by the opposite route. The primary outcomes were time to delivery and the rate of cesarean delivery performed urgently for fetal nonreassurance. A sample size of 300 was planned to test the noninferiority hypothesis. The trial enrolled 319 women, with 300 available for analysis, 152 in the vaginal misoprostol group and 148 in the buccal. Groups had similar baseline characteristics. We were unable to demonstrate noninferiority. The time to vaginal delivery was lower for the vaginal misoprostol group (median [95% confidence interval] in hours: vaginal: 20.1 [18.2, 22.8] vs buccal: 28.1 [24.1, 31.4], log-rank test P= .006, Pnoninferiority= .663). The rate of cesarean deliveries for nonreassuring fetal status was 3.3% for the vaginal misoprostol group and 9.5% for the buccal misoprostol group (P= .033). The rate of vaginal delivery in <24 hours was higher in the vaginal group (58.6% vs 39.2%, P= .001). We were unable to demonstrate noninferiority. In leading to a higher rate of vaginal deliveries, more rapid vaginal delivery, and fewer cesareans for fetal issues, vaginal misoprostol may be superior to buccal misoprostol for cervical ripening at term.

Effectiveness of misoprostol administration for cervical ripening in women before operative hysteroscopy: a randomized, double-blinded controlled trial

Objective: To compare the effectiveness of misoprostol administration orally or vaginally for cervical ripening in women before operative hysteroscopy surgery.Material and methods: Two hundred seventy-five women eligible for operative hysteroscopy were recruited for a controlled, blinded, randomized trial. Twenty-two women were excluded from the study. Patients were randomly assigned to take 600 µg of misoprostol or 30 mg vitamin B6 orally or vaginally, respectively, 4–12 h before operative hysteroscopy. Main outcome measures: Extent of cervical diameter before the hysteroscopy procedure, need for further cervical dilatation, degree of ease of cervical dilation, duration of additional cervix dilatation and hysteroscopy procedure, abdominal pain prior to surgical procedure, patients’ acceptability, complications and associated side effects during the hysteroscopy procedures.Results: Cervical width in the vaginal and oral misoprostol groups after administration was 7.2 ± 0.9 mm and 7.5 ± 1.4 mm, respectively, a statistically significant difference compared to the control group. The duration required for cervical priming with misoprostol, either vaginally or orally (75 ± 24 s or 82 ± 22 s), was significantly shorter than that of placebo (148 ± 31 s). The effect of cervical dilation with misoprostol was significantly higher in the premenopausal participants. Occurrence of uterine false tract substantially increased in the placebo group. Meanwhile, the risk of side-effects increased in the misoprostol-treated patients compared to the control group.Conclusions: The administration of misoprostol seemed more effective than the control for preoperative cervical priming in menstrual participants. Further large randomized controlled trials are needed to determine whether misoprostol could reduce complications with fewer side-effects and to establish whether misoprostol has a substantial cervical dilation effect on either premenopausal or postmenopausal patients.