Timing of planned birth in women with gestational hypertension or pre-eclampsia without severe features: protocol for a multicentre, stratified randomised controlled trial (OPTIMoM-TIME: optimising management of mothers with hypertension: timing of birth)

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Hypertensive disorders of pregnancy (HDP) complicate 6–8% of pregnancies worldwide, with the burden highest in low- and middle-income countries (LMICs), including India. Current guidelines recommend planned birth from 37 weeks onwards for gestational hypertension or pre-eclampsia without severe features. However, earlier birth may reduce the risks of maternal deterioration, while increasing the neonatal morbidity from early -term birth. This randomised controlled trial will compare the impact of planned birth at 37 weeks with expectant management until 39 weeks with gestational hypertension or pre-eclampsia without severe features, on maternal and fetal outcomes. A total of 1200 women with gestational hypertension or pre-eclampsia will be randomly allocated in a 1:1 Ratio (600 per arm) to planned birth at 37 + 0 weeks of gestation or expectant management until 39 weeks. Women in both arms will undergo close maternal and fetal surveillance according to the trial protocol, with earlier birth undertaken if clinically indicated. Randomisation will be stratified and follow a biased-coin minimisation algorithm incorporating prespecified prognostic factors, while retaining a random element to preserve allocation unpredictability. The primary analysis will adhere to the intention-to-treat (ITT) principle. Outcomes will be assessed through postnatal hospital discharge, with planned long-term follow-up to 18 months postpartum. The primary outcomes of this trial are a composite perinatal outcome and a composite maternal adverse outcome. This multicentre RCT (OPTIMoM-TIME trial) will evaluate whether planned birth at 37 weeks or expectant management until 39 weeks provides the balance between the maternal and perinatal outcomes in women with gestational hypertension or pre-eclampsia without severe features. The findings will provide robust evidence to inform shared decision-making about the timing of birth to optimise the outcome for the mother-baby dyad, and to guide clinicians, patients and healthcare systems in implementing maternity care policy and services effectively. CTRI/2025/07/090538, Clinical Trials Registry- India (CTRI). Registered on July 9th, 2025.

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