Community level interventions for pre-eclampsia (CLIP) in India: A cluster randomised controlled trial

Area of Science:

• Obstetrics and Gynecology
• Public Health
• Health Services Research

Background:

• Pregnancy hypertension contributes significantly to maternal mortality in India.
• Delays in triage, transport, and treatment exacerbate adverse pregnancy outcomes.
• Task-sharing care models are being explored to improve maternal and newborn health.

Purpose of the Study:

• To assess if task-sharing care, via community health workers, could reduce adverse pregnancy outcomes associated with hypertension.
• To evaluate the impact of the Indian Community-Level Interventions for Pre-eclampsia (CLIP) trial on maternal, fetal, and newborn mortality and morbidity.

Main Methods:

• An open-label, cluster-randomised controlled trial involving 14,783 pregnancies in Karnataka, India.
• Intervention group received mHealth-guided assessment, treatment, and referral by community health workers (CHWs).
• Primary outcome was a composite of mortality and major morbidity; analyzed using multi-level logistic regression.

Main Results:

• No significant difference in the primary outcome between the intervention and control groups (aOR 0.92; p=0.47).
• No safety concerns were identified with the administered treatments (methyldopa, MgSO4).
• Higher engagement (≥8 contacts) with CHWs was associated with reduced stillbirths but a trend towards increased neonatal morbidity.

Conclusions:

• The implemented community-level interventions focused on pre-eclampsia did not improve overall adverse pregnancy outcomes in northwest Karnataka.
• While not improving the primary composite outcome, the intervention showed potential benefits in reducing stillbirths with increased CHW contact.