Dataset Information

The Induction with Foley OR Misoprostol (INFORM) Study dataset. A dataset of 602 women with hypertensive disease in pregnancy, in India, randomised to either Foley catheter or oral misoprostol for induction of labour.

ABSTRACT:

Objectives

Induction of labour (IOL), or starting labour artificially, can be a lifesaving intervention for pregnant women and their babies, and rates are rising significantly globally. As rates increase, it becomes increasingly important to fully evaluate all available data, especially that from low income settings where the potential benefits and harms are greater. The goal of this paper is to describe the datasets collected as part of the Induction with Foley OR Misoprostol (INFORM) Study, a randomised trial comparing two of the recommended methods of cervical ripening for labour induction, oral misoprostol and Foley catheter, in women being induced for hypertension in pregnancy, at two sites in India during 2013-15.

Data description

This dataset includes comprehensive data on 602 women who underwent IOL for hypertensive disorders in pregnancy. Women were randomly assigned to cervical ripening with oral misoprostol or a transcervical Foley catheter in two government hospitals in India. The main dataset has 367 variables including monitoring during the induction of labour, medications administered, timing and mode of delivery, measures of neonatal morbidity and mortality, maternal mortality and morbidity, maternal satisfaction and health economic data. The dataset is anonymised and available on ReShare.

SUBMITTER: Mundle S

PROVIDER: S-EPMC8434713 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:ObjectiveTo determine the effectiveness and economic impact of two methods for induction of labour in hypertensive women, in low-resource settings.DesignCost-consequence analysis of a previously reported multicentre, parallel, open-label randomised trial.Setting & populationA total of 602 women with a live fetus, aged ≥18 years requiring delivery for pre-eclampsia or hypertension, in two public hospitals in Nagpur, India.MethodsWe performed a formal economic evaluation alongside the INFORM clinical trial. Women were randomised to receive transcervical Foley catheterisation or oral misoprostol 25 mcg. Healthcare expenditure was calculated using a provider-side microcosting approach.Main outcome measuresRates of vaginal this delivery within 24 hours of induction, healthcare expenditure per completed treatment episode.ResultsInduction with oral misoprostol resulted in a (mean difference) $20.6USD reduction in healthcare expenditure [95% CI (-) $123.59 (-) $72.49], and improved achievement of vaginal delivery within 24 hours of induction, mean difference 10% [95% CI (-2 to 17.9%), P = 0.016]. Oxytocin administration time was reduced by 135.3 minutes [95% CI (84.4-186.2 minutes), P < 0.01] and caesarean sections by 9.1% [95% CI (1.1-17%), P = 0.025] for those receiving oral misoprostol. Following probabilistic sensitivity analysis, oral misoprostol was cost-saving in 63% of 5,000 bootstrap replications and achieved superior rates of vaginal delivery, delivery within 24 hours of induction and vaginal delivery within 24 hours of induction in 98.7%, 90.7%, and 99.4% of bootstrap simulations. Based on univariate threshold analysis, the unit price of oral misoprostol 25 mcg could feasibly increase 31-fold from $0.24 to $7.50 per 25 mcg tablet and remain cost-saving.ConclusionCompared to Foley catheterisation for the induction of high-risk hypertensive women, oral misoprostol improves rates of vaginal delivery within 24 hours of induction and may also reduce costs. Additional research performed in other low-resource settings is required to determine their relative cost-effectiveness.Tweetable abstractOral misoprostol less costly and more effective than Foley catheter for labour induction in hypertension.

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:Currently, there is no meta-analysis comparing intravaginal misoprostol plus intracervical Foley catheter versus intravaginal misoprostol alone for term pregnancy without identifying risk factors. Therefore, the purpose of this study is to conduct a systematic review and meta-analysis of randomized control trials (RCTs) comparing concurrent intravaginal misoprostol and intracervical Foley catheter versus intravaginal misoprostol alone for cervical ripening. We systematically searched Embase, Pubmed, and Cochrane Collaboration databases for randomized controlled trials (RCTs) comparing intracervical Foley catheter plus intravaginal misoprostol and intravaginal misoprostol alone using the search terms "Foley", "misoprostol", "cervical ripening", and "induction" up to 29 January 2019. Data were extracted and analyzed by two independent reviewers including study characteristics, induction time, cesarean section (C/S), clinical suspicion of chorioamnionitis, uterine tachysystole, meconium stain, and neonatal intensive care unit (NICU) admissions. Data was pooled using random effects modeling and calculated with risk ratio (RR) and 95% confidence interval (CI). Pooled analysis from eight studies, including 1110 women, showed that labor induction using a combination of intracervical Foley catheter and intravaginal misoprostol decreased induction time by 2.71 h (95% CI -4.33 to -1.08, p = 0.001), as well as the risk of uterine tachysystole and meconium staining (RR 0.54, 95% CI 0.30-0.99 and RR 0.48, 95% CI 0.32-0.73, respectively) significantly compared to those using intravaginal misoprostol alone. However, there was no difference in C/S rate (RR 0.93, 95% CI 0.78-1.11) or clinical suspicion of chorioamnionitis rate (RR 1.22, CI 0.58-2.57) between the two groups. Labor induction with a combination of intracervical Foley catheter and intravaginal misoprostol may be a better choice based on advantages in shortening induction time and reducing the risk of uterine tachysystole and meconium staining compared to intravaginal misoprostol alone.

Project description:BackgroundEvery year approximately 30,000 women die from hypertensive disease in pregnancy. Magnesium sulphate and anti-hypertensives reduce morbidity, but delivery is the only cure. Low dose oral misoprostol, a prostaglandin E1 analogue, is a highly effective method for labour induction. Usually, once active labour has commenced, the misoprostol is replaced with an intravenous oxytocin infusion if ongoing stimulation is required. However, some studies have shown that oral misoprostol can be continued into active labour, a simpler and potentially more acceptable protocol for women. To date, these two protocols have never been directly compared.MethodsThis pragmatic, open-label, randomised trial will compare a misoprostol alone labour induction protocol with the standard misoprostol plus oxytocin protocol in three Indian hospitals. The study will recruit 520 pregnant women being induced for hypertensive disease in pregnancy and requiring augmentation after membrane rupture. Participants will be randomised to receive either further oral misoprostol 25mcg every 2 h, or titrated intravenous oxytocin. The primary outcome will be caesarean birth. Secondary outcomes will assess the efficacy of the induction process, maternal and fetal/neonatal complications and patient acceptability. This protocol (version 1.04) adheres to the SPIRIT checklist. A cost-effectiveness analysis, situational analysis and formal qualitative assessment of women's experience are also planned.DiscussionAvoiding oxytocin and continuing low dose misoprostol into active labour may have a number of benefits for both women and the health care system. Misoprostol is heat stable, oral medication and thus easy to store, transport and administer; qualities particularly desirable in low resource settings. An oral medication protocol requires less equipment (e.g. electronic infusion pumps) and may free up health care providers to assist with other aspects of the woman's care. The simplicity of the protocol may also help to reduce human errors associated with the delivery of intravenous infusions. Finally, women may prefer to be mobile during labour and not restricted by an intravenous infusion. There is a need, therefore, to assess whether augmentation using oral misoprostol is superior clinically and economically to the standard protocol of intravenous oxytocin.Trial registrationClinical Trials.gov, NCT03749902 , registered on 21st Nov 2018.

Dataset Information

The Induction with Foley OR Misoprostol (INFORM) Study dataset. A dataset of 602 women with hypertensive disease in pregnancy, in India, randomised to either Foley catheter or oral misoprostol for induction of labour.

Objectives

Data description

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets