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)
Year: 2026
Type: article
Study design: Study Protocol
Abstract: 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.
Source: BMC Pregnancy and Childbirth
Authors: Anish Keepanasseril, Nishad Plakkal, Dilip Kumar Maurya, Seema Chopra, Avantika Gupta, K Aparna Sharma, Avinash Anantharaj, Gowri Dorairajan, Nalini Sharma, Saubhagya Kumar Jena, Shravasti Gedam, Kirthika Sivanandham, N Sreekumaran Nair, Vanita Jain, Sitanshu Sekhar Kar, Shuchita Ramesh Mundle, the OPTIMoM trial Group, Amit Malviya, Amrita Singh, Anu Sachdeva, Anubhuti Rana, Awanti Krushnarao Kumbhalwar, Bhushan Shah, Chetan Khare, Debasis Acharya, Deepali Garg, Jagdish Prasad Sahoo, Kanya Mukhopadhyay, Jena Madhusmita, Megha Singh Parihar, Nishant Banait, Nitu Mishra, Pruthwiraj Sethi, Rajesh Vijayvergiya, Rosina Ksoo, Sagar Makade, Saurabh Kumar Gupta, Sonali Mehta, Sraddha Singh, Sukhith Shivalingaiah, Thankachan Traison, Th Cynthia M Fancon
Institutions: Jawaharlal Institute of Post Graduate Medical Education and Research, Post Graduate Institute of Medical Education and Research, All India Institute of Medical Sciences Bhopal, All India Institute of Medical Sciences, North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences, All India Institute of Medical Sciences Bhubaneswar, All India Institute of Medical Sciences, Nagpur
Language: English
Subfield: Obstetrics and Gynecology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $3,290
Award: G2656993538
OpenAlex ID: W7208762540
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