The Induction with Foley OR Misoprostol (INFORM) Study, 2013-2015

DOI

This dataset includes comprehensive data on 602 women who underwent induction of labour for hypertensive disorders in pregnancy. Women were randomly assigned to cervical ripening with oral misoprostol or a transcervical Foley catheter in two 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, in addition to health economic data. The dataset is anonymised and available in CSV and Excel formats with a data dictionary.Hypertensive disorders in pregnancy are a major cause of death worldwide, killing up to 80,000 pregnant women annually. For women with preeclampsia currently available therapies improve the outcome of the illness, but the final cure only comes with delivery of the baby. Prompt delivery, preferably by the vaginal route rather than by caesarean section, is therefore vital to achieve good maternal and neonatal outcomes. Two low-cost interventions—low-dose oral misoprostol tablets and transcervical Foley catheterisation—are already used in low-resource settings. We aimed to compare the relative risks and benefits of these interventions. We undertook this multicentre, open-label, randomised controlled trial in two public hospitals in Nagpur, India. Women (aged ≥18 years) who were at 20 weeks gestation or later with a live fetus and required delivery as a result of preeclampsia or hypertension, were randomly assigned to receive labour induction with either oral misoprostol or a transcervical Foley catheter. The primary outcome was vaginal birth within 24 h. Due to the nature of the interventions, masking of participants, study investigators, and care providers to group allocation was not possible. We analysed by intention to treat.

602 women with a live fetus requiring delivery for pre-eclampsia or uncontrolled hypertension were randomly assigned to cervical ripening with oral misoprostol 25 micrograms every 2 hours (maximum of 12 doses) or a transcervical Foley catheter (size 18 F with 30 ml balloon) which remained until active labour started, the Foley catheter fell out, or 12 hours elapsed. Induction continued with artificial membrane rupture and oxytocin, administered through a micro-drip gravity infusion set. Fetal monitoring was by intermittent auscultation.

Identifier
DOI https://doi.org/10.5255/UKDA-SN-854663
Metadata Access https://datacatalogue.cessda.eu/oai-pmh/v0/oai?verb=GetRecord&metadataPrefix=oai_ddi25&identifier=46ca5ce49fd6c3ab562bb6a74eb63b3333d0ee670a33254ffea682d686b73325
Provenance
Creator Mundle, S, All India Institute of Medical Sciences; Bracken, H, Gynuity Health Projects (GHP); Khedikar, V, Daga Memorial Women’s Government Hospital; Mulik, J, Government Medical College; Faragher, B, Liverpool School of Tropical Medicine; Easterling, T, University of Washington; Leigh, S, Nexus Clinical Analytics; Granby, P, Certus Analytics; Haycox, A, University of Liverpool Management School; Turner, M, University of Liverpool; Alfirevic, Z, University of Liverpool; Winikoff, B, Gynuity Health Projects (GHP); Weeks, A, University of Liverpool
Publisher UK Data Service
Publication Year 2021
Funding Reference Department for International Development; Medical Research Council; Wellcome Trust
Rights Andrew D Weeks, University of Liverpool; The Data Collection is available to any user without the requirement for registration for download/access.
OpenAccess true
Representation
Resource Type Numeric; Text
Discipline Social Sciences
Spatial Coverage Nagpur; INDIA