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

Mundle, Shuchita and Bracken, Hillary and Khedikar, Vaishali and Mulik, Jayashree and Faragher, Brian and Easterling, Thomas and Leigh, Simon and Granby, Paul and Haycox, Alan and Turner, Mark A and Alfirevic, Zarko and Winikoff, Beverly and Weeks, Andrew D (2021). The Induction with Foley OR Misoprostol (INFORM) Study, 2013-2015. [Data Collection]. Colchester, Essex: UK Data Service. 10.5255/UKDA-SN-854663

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.

Data description (abstract)

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.

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