Foley Catheter versus Vaginal Misoprostol: Randomized Controlled Trial (PROBAAT-M Study) and Systematic Review and Meta-Analysis of Literature

Jozwiak, Marta; Eikelder, M. ten; Rengerink, Katrien Oude; Groot, Christianne de; Feitsma, H.; Spaanderman, Marc E. A.; Pampus, Maria G. van; Leeuw, J.W. de; Mol, Ben Willem J.; Bloemenkamp, Kitty W. M.

doi:10.1055/s-0033-1341573

Cited by 27 publications

(29 citation statements)

References 25 publications

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“…In our study, adverse events such as CS, postpartum haemorrhage, meconium-stained amniotic fluid, Apgar score below 7, fetal acidosis (defined by arterial pH < 7.15), and neonatal complications were similar in both groups. In line with previous studies, we detected a relatively high incidence of uterine tachysystole after Misoprostol use [ 8 , 23 , 24 ]. For example, Jozwiak et al reported a 61% reduction of uterine hyperstimulation in the Foley catheter group compared to the use of 25 μg MVT and Hofmeyr et al reported a lower incidence of tachysystole with similar results using vaginal / intracervical dinoprostone [ 8 , 23 ].…”

Section: Discussionsupporting

confidence: 92%

“…In line with previous studies, we detected a relatively high incidence of uterine tachysystole after Misoprostol use [ 8 , 23 , 24 ]. For example, Jozwiak et al reported a 61% reduction of uterine hyperstimulation in the Foley catheter group compared to the use of 25 μg MVT and Hofmeyr et al reported a lower incidence of tachysystole with similar results using vaginal / intracervical dinoprostone [ 8 , 23 ]. Efficacy of misoprostol seems to be correlated with the dosage and therefore several studies focused on determining the optimal dosing regimen.…”

Section: Discussionsupporting

confidence: 92%

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Misoprostol vaginal insert versus misoprostol vaginal tablets for the induction of labour: a cohort study

Bolla

Weissleder

Radan

et al. 2018

BMC Pregnancy Childbirth

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BackgroundMisoprostol vaginal insert for induction of labor has been recently reported to be superior to dinoprostone vaginal insert in a phase III trial, but has never been compared to vaginal misoprostol in another galenic form. The aim of this study was to compare misoprostol vaginal insert (MVI) with misoprostol vaginal tablets (MVT) for induction of labor in term pregnancies.MethodsIn this retrospective cohort study we compared 200 consecutive women induced with 200-μg misoprostol 24-h vaginal insert (Misodel®) with a historical control of 200 women induced with Misoprostol 25-μg vaginal tablets (Cytotec®) every 4-6 h. Main outcomes variables included induction-to-delivery interval, vaginal delivery within 24-h, incidence of tachysystole, mode of delivery, and neonatal outcome. A subanalysis in the MVI group was performed in order to identify predictive factors for tachysistole and vaginal delivery within 24 h.ResultsThe time from induction to vaginal delivery was 1048 ± 814 min in the MVI group and 1510 ± 1043 min in the MVT group (p < 0.001). Vaginal delivery within 24-h occurred in 127 (63.5%) patients of the MVI group and in 110 (55%) patients of the MVT group (p < 0.001). Tachysystole was more common in the MVI group (36% vs. 18%; p < 0.001). However, no significant predictors of uterine tachysystole in MVI group have been identified in crude and fully adjusted logistic regression models. Bishop score was the only predictor for vaginal delivery within 24 h (p < 0.001) in MVI group. Caesarean delivery rate (27% vs. 20%) and vaginal-operative deliveries (15.5% vs. 15.5%) did not differ significantly between the two groups. Neonatal outcomes were similar in both groups.ConclusionsMVI achieves a more vaginal delivery rate within 24 h and Tachysystole events compared to MVT. However, no differences in caesarean section, operative vaginal delivery, and neonatal outcomes are reported. No predictors of tachysistole after MVI administration have been identified. Bishop score and parity are the only predictors of vaginal delivery within 24 h after MVI administration.

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Section: Discussionsupporting

confidence: 92%

Section: Discussionsupporting

confidence: 92%

Misoprostol vaginal insert versus misoprostol vaginal tablets for the induction of labour: a cohort study

Bolla

Weissleder

Radan

et al. 2018

BMC Pregnancy Childbirth

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“…Previous randomized trials have found no difference in the rate of cesarean delivery between women undergoing cervical ripening with prostaglandins as compared to Foley catheter (39, 40). …”

Section: Discussionmentioning

confidence: 85%

Predicting Cesarean Delivery After Induction of Labor Among Nulliparous Women at Term

Tolcher

Holbert

Weaver

et al. 2015

Obstetrics &Amp; Gynecology

146

114

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OBJECTIVES To identify independent risk factors for cesarean delivery after induction of labor (IOL) and to develop a nomogram for predicting cesarean delivery among nulliparous women undergoing IOL at term. METHODS This is a retrospective cohort study including nulliparous women with singleton, term (≥37 0/7 weeks of gestation), cephalic pregnancies undergoing IOL from July 1, 2006, through May 31, 2012, at a tertiary care academic center. Inductions were identified using ICD-9 codes. Demographic, delivery, and outcome data were abstracted manually from the medical record. Women with a contraindication to vaginal delivery (malpresentation, abnormal placentation, prior myomectomy) were excluded. Independent risk factors for cesarean delivery were identified using logistic regression. RESULTS During the study period, there were 785 nulliparous inductions who met study criteria; 231 (29.4%) underwent cesarean delivery. Independent risk factors associated with an increased risk of cesarean delivery included older maternal age, shorter maternal height, greater body mass index, greater weight gain during pregnancy, older gestational age, hypertension, diabetes mellitus, and initial cervical dilation <3 cm. A nomogram was constructed based on the final model with a bias-corrected c-index of 0.709 (95% CI 0.671–0.750). CONCLUSION We identified independent risk factors which can be utilized to predict cesarean delivery among nulliparous women undergoing IOL at term. If validated in other populations, the nomogram could be useful for individualized counseling of women with a combination of identifiable antepartum risk factors.

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“…Of the 103 trials identified, just 63 were RCTs. 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 The majority of RCTs were single-center trials conducted in academic hospitals, which can limit the generalizability of the results to other community-based populations. Among the 12 multicenter trials, the number of centers ranged from 2 to 49 and tended to include both university-affiliated and community hospitals.…”

Section: Limitations Of Trials On Labor Inductionmentioning

confidence: 99%

“…4 The goal of labor induction should be vaginal delivery because cesarean deliveries are associated with increased risk to the mother and infant, as well as higher health care costs. 2 99 100 Of the 63 RCTs we reviewed, just six used cesarean section rate as a primary outcome measure 40 47 54 64 74 84 ; however, two of the trials were not adequately powered.…”

Section: Limitations Of Trials On Labor Inductionmentioning

confidence: 99%

Challenges and Limitations of Clinical Trials on Labor Induction: A Review of the Literature

Viteri

Sibai

2018

AJP Rep

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Induction of labor is a common obstetric procedure performed in nearly a quarter of all deliveries in the United States. Pharmacological (prostaglandins, oxytocin) and/or mechanical methods (balloon catheters) are commonly used for labor induction; however, there is ongoing debate as to which method is the safest and most effective. This narrative review discusses key limitations of published trials on labor induction, including the lack of well-designed randomized controlled trials directly comparing specific methods of induction, heterogeneous trial populations, and wide variation in the protocols used and outcomes reported. Furthermore, the majority of published trials were underpowered to detect significant differences in the most clinically relevant efficacy and safety outcomes (e.g., cesarean delivery, neonatal mortality). By identifying the limitations of labor induction trials, we hope to highlight the importance of quality published data to better inform guidelines and drive evidence-based treatment decisions.

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Foley Catheter versus Vaginal Misoprostol: Randomized Controlled Trial (PROBAAT-M Study) and Systematic Review and Meta-Analysis of Literature

Cited by 27 publications

References 25 publications

Misoprostol vaginal insert versus misoprostol vaginal tablets for the induction of labour: a cohort study

Misoprostol vaginal insert versus misoprostol vaginal tablets for the induction of labour: a cohort study

Predicting Cesarean Delivery After Induction of Labor Among Nulliparous Women at Term

Challenges and Limitations of Clinical Trials on Labor Induction: A Review of the Literature

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