Induction of labor using Foley catheter with weight attached versus without weight attached: A randomized control trial.

OBJECTIVE: To assess the effectiveness in preventing cesarean section for failed induction by using Foley catheter for cervical ripening in comparison to Foley catheter with a weight attached to it. METHODS: A randomized control trial conducted between November 2018 and July 2020, which looked at induction of labor with 30-ml Foley catheter in one arm and the Foley placed with a 500 ml weight attached to it in the other arm. Primary outcome was the cesarean section rate. RESULTS: We randomized 399 women. Modes of delivery were similar in both groups. Numbers undergoing cesarean section for failed induction were higher in the group that underwent induction with Foley with weight but this was not statistically significant (45.7% vs 26.5%, P = 0.1). There was a shorter time to expulsion of the Foley with weight attached (mean ± standard deviation: 2.6 ± 3.3 h vs 10.9 ± 3.2 h, P < 0.001) but this did not translate into a difference in time to active labor or time to delivery. CONCLUSION: Placing a weight at the end of the Foley catheter for induction of labor does not affect the time to delivery or the rate of cesarean deliveries, although there is faster expulsion of the Foley. CLINICAL TRIAL REGISTRATION NO: CTRI/2018/10/016154.

Pregnancy-related interventions in mothers at risk for gestational diabetes in Asian India and low and middle-income countries (PRIMORDIAL study): protocol for a randomised controlled trial.

INTRODUCTION: Lifestyle modification is the mainstay of gestational diabetes mellitus (GDM) prevention. However, clinical trials evaluating the safety and efficacy of diet or physical activity (PA) in low-income and middle-income settings such as Africa and India are lacking. This trial aims to evaluate the efficacy of yoghurt consumption and increased PA (daily walking) in reducing GDM incidence in high-risk pregnant women. METHODS AND ANALYSIS: The study is a 2×2 factorial, open-labelled, multicentre randomised controlled trial to be conducted in Vellore, South India and The Gambia, West Africa. 'High-risk' pregnant women (n=1856) aged ≥18 years and ≤16 weeks of gestational age, with at least one risk factor for developing GDM, will be randomised to either (1) yoghurt (2) PA (3) yoghurt +PA or (4) standard antenatal care. Participants will be followed until 32 weeks of gestation with total active intervention lasting for a minimum of 16 weeks. The primary endpoint is GDM incidence at 26-28 weeks diagnosed using International Association of the Diabetes and Pregnancy Study Groups criteria or elevated fasting glucose (≥5.1 mmol/L) at 32 weeks. Secondary endpoints include absolute values of fasting plasma glucose concentration at 32 weeks gestation, maternal blood pressure, gestational weight gain, intrapartum and neonatal outcomes. Analysis will be both by intention to treat and per-protocol. Continuous outcome measurements will be analysed using multiple linear regression and binary variables by logistic regression. ETHICS AND DISSEMINATION: The study is approved by Oxford Tropical Research Ethics Committee (44-18), ethics committees of the Christian Medical College, Vellore (IRB 11367) and MRCG Scientific Coordinating Committee (SCC 1645) and The Gambia Government/MRCG joint ethics committee (L2020.E15). Findings of the study will be published in peer-reviewed scientific journals and presented in conferences. TRIAL REGISTRATION NUMBER: ISRCTN18467720.