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Vaginal prostaglandin (PGE2 and PGF2a) for induction of labour at term.

ABSTRACT: BACKGROUND:Prostaglandins have been used for induction of labour since the 1960s. This is one of a series of reviews evaluating methods of induction of labour. This review focuses on prostaglandins given per vaginam, evaluating these in comparison with placebo (or expectant management) and with each other; prostaglandins (PGE2 and PGF2a); different formulations (gels, tablets, pessaries) and doses. OBJECTIVES:To determine the effects of vaginal prostaglandins E2 and F2a for third trimester cervical ripening or induction of labour in comparison with placebo/no treatment or other vaginal prostaglandins (except misoprostol). SEARCH METHODS:We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (1 March 2014) and bibliographies of relevant papers. SELECTION CRITERIA:Clinical trials comparing vaginal prostaglandins used for third trimester cervical ripening or labour induction with placebo/no treatment, with each other, or other methods listed above it on a predefined list of labour induction methods. DATA COLLECTION AND ANALYSIS:We assessed studies and extracted data independently. MAIN RESULTS:Seventy randomised controlled trials (RCTs) (11,487 women) are included. In this update seven new RCTs (778 women) have been added. Two of these new trials compare PGE2 with no treatment, four compare different PGE2 formulations (gels versus tablets, or sustained release pessaries) and one trial compares PGF2a with placebo. The majority of trials were at unclear risk of bias for most domains.Overall, vaginal prostaglandin E2 compared with placebo or no treatment probably reduces the likelihood of vaginal delivery not being achieved within 24 hours. The risk of uterine hyperstimulation with fetal heart rate changes is increased (4.8% versus 1.0%, risk ratio (RR) 3.16, 95% confidence interval (CI) 1.67 to 5.98, 15 trials, 1359 women). The caesarean section rate is probably reduced by about 10% (13.5% versus 14.8%, RR 0.91, 95% CI 0.81 to 1.02, 36 trials, 6599 women). The overall effect on improving maternal and fetal outcomes (across a variety of measures) is uncertain.PGE2 tablets, gels and pessaries (including sustained release preparations) appear to be as effective as each other, small differences are detected between some outcomes, but these maybe due to chance. AUTHORS' CONCLUSIONS:Prostaglandins PGE2 probably increase the chance of vaginal delivery in 24 hours, they increase uterine hyperstimulation with fetal heart changes but do not effect or may reduce caesarean section rates. They increase the likelihood of cervical change, with no increase in operative delivery rates. PGE2 tablets, gels and pessaries appear to be as effective as each other, any differences between formulations are marginal but may be important.

SUBMITTER: Thomas J

PROVIDER: S-EPMC7138281 | biostudies-literature | 2014 Jun

REPOSITORIES: biostudies-literature

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Vaginal prostaglandin (PGE2 and PGF2a) for induction of labour at term.

Thomas Jane J Fairclough Anna A Kavanagh Josephine J Kelly Anthony J AJ

The Cochrane database of systematic reviews 20140619 6

<h4>Background</h4>Prostaglandins have been used for induction of labour since the 1960s. This is one of a series of reviews evaluating methods of induction of labour. This review focuses on prostaglandins given per vaginam, evaluating these in comparison with placebo (or expectant management) and with each other; prostaglandins (PGE2 and PGF2a); different formulations (gels, tablets, pessaries) and doses.<h4>Objectives</h4>To determine the effects of vaginal prostaglandins E2 and F2a for third ...[more]

PMID: 24941907

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Project description:IntroductionPremature rupture of membranes (PROM) occurs at term in 8% of pregnancies. Several studies have demonstrated that the risk of chorioamnionitis and neonatal sepsis increases with duration of PROM. Decreasing the time interval between PROM and delivery is associated with lower rates of maternal infections. In case of an unfavourable cervix, the use of prostaglandin for cervical maturation demonstrates some advantages over oxytocin. The use of double balloon catheter in reduction of PROM duration has not been evaluated in the literature.Methods and analysisWe are conducting a prospective, monocentric, randomised clinical trial on pregnant women with an unfavourable cervix showing PROM at term (RUBAPRO).After 12-24 hours of PROM, women are randomly assigned to one group treated with a double balloon catheter for 12 hours, with oxytocin administered after 6 hours or to the control group treated with 24 hours of vaginal prostaglandin followed by oxytocin infusion alone. Patients (n=80) are randomised at a 1:1 ratio with stratification on parity.The inclusion criteria are a Bishop score of <6, cephalic presentation at term and confirmed PROM. Women with suspected chorioamnionitis; group B streptococcus (GBS) carrier; a history of caesarean delivery or any contraindication for vaginal delivery are excluded.The time from induction to delivery is the primary outcome. Secondary outcomes were mode of delivery, maternofetal morbidity and the effect of parity on strategies for reduction of PROM duration.To sufficiently demonstrate a difference (10 hours) between groups-with a statistical power of 90% and a two-tailed α of 5%-40 patients per group will be required.Ethics and disseminationWritten informed consent is required from participants.National Ethics Committee approval was obtained in August 2017. The results will be published in a peer-reviewed journal and presented at relevant conferences. Access to raw data will be available only to members of the research team.Trial registration numberNCT03310333.

Project description:BackgroundInduction of labour (IOL) is one of the commonest obstetric interventions, with significant impact on both the individual woman and health service delivery. Outpatient IOL is an attractive option to reduce these impacts. To date there is little data comparing outpatient and inpatient IOL methods, and potential safety concerns (hyperstimulation) if prostaglandins, the standard inpatient IOL medications, are used in the outpatient setting. The purpose of this study was to assess feasibility, clinical effectiveness and patient acceptability of outpatient Foley catheter (OPC) vs. inpatient vaginal PGE2 (IP) for induction of labour (IOL) at term.MethodsWomen with an unfavourable cervix requiring IOL at term (N=101) were randomised to outpatient care using Foley catheter (OPC, n=50) or inpatient care using vaginal PGE2 (IP, n=51). OPC group had Foley catheter inserted and were discharged overnight following a reassuring cardiotocograph. IP group received 2 mg/1 mg vaginal PGE2 if nulliparous or 1 mg/1 mg if multiparous. Main outcome measures were inpatient stay (prior to birth, in Birthing Unit, total), mode of birth, induction to delivery interval, adverse reactions and patient satisfaction.ResultsOPC group had shorter hospital stay prior to birth (21.3 vs. 32.4 hrs, p< .001), IP were more likely to achieve vaginal birth within 12 hours of presenting to Birthing Unit (53% vs. 28%, p= .01). Vaginal birth rates (66% OPC Vs. 71% IP), total induction to delivery time (33.5 hrs vs. 31.3 hrs) and total inpatient times (96 hrs OPC Vs. 105 hrs IP) were similar. OPC group felt less pain (significant discomfort 26% Vs 58%, p=.003), and had more sleep (5.8 Vs 3.4 hours, p< .001), during cervical preparation, but were more likely to require oxytocin IOL (88 Vs 59%, p=.001).ConclusionsOPC was feasible and acceptable for IOL of women with an unfavourable cervix at term compared to IP, however did not show a statistically significant reduction in total inpatient stay and was associated with increased oxytocin IOL.Trial registrationAustralian New Zealand Clinical Trials Registry, ACTRN:12609000420246.

Project description:BACKGROUND:There is high-quality evidence supporting induction of labour (IOL) for a number of maternal and fetal indications. However, one fifth of inductions fail to result in vaginal births, requiring cesarean deliveries. This has negative clinical, emotional and resource implications. The importance of predicting the success of labour induction to enable shared decision-making has been recognized, but existing models are limited in scope and generalizability. Our objective was to derive and internally validate a clinical prediction model that uses variables readily accessible through maternal demographic data, antenatal history, and cervical examination to predict the likelihood of vaginal birth following IOL. METHODS:Data was extracted from electronic medical records of consecutive pregnant women who were induced between April and December 2016, at Mount Sinai Hospital, Toronto, Canada. A multivariable logistic regression model was developed using 16 readily accessible variables identified through literature review and expert opinion, as predictors of vaginal birth after IOL. The final model was internally validated using 10-fold cross-validation. RESULTS:Of the 1123 cases of IOL, 290 (25.8%) resulted in a cesarean delivery. The multivariable logistic regression model found maternal age, parity, pre-pregnancy body mass index and weight, weight at delivery, and cervical dilation at time of induction as significant predictors of vaginal delivery following IOL. The prediction model was well calibrated (Hosmer-Lemeshow ?2?=?5.02, p?=?0.76) and demonstrated good discriminatory ability (area under the receiver operating characteristic (AUROC) curve, 0.81 (95% CI 0.78 to 0.83)). Finally, the model showed good internal validity [AUROC 0.77 (95% CI 0.73 to 0.82)]. CONCLUSIONS:We have derived and internally validated a well-performing clinical prediction model for IOL in a large and diverse population using variables readily accessible through maternal demographic data, antenatal history, and cervical examination. Once prospectively validated in diverse settings, and if shown to be acceptable to pregnant women and healthcare providers as well as clinically and cost-effective, this model has potential for widespread use in clinical practice and research for enhancing patient autonomy, improving induction outcomes, and optimizing allocation of resources.

Dataset Information

Vaginal prostaglandin (PGE2 and PGF2a) for induction of labour at term.

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Vaginal prostaglandin (PGE2 and PGF2a) for induction of labour at term.

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