251. Community Level Interventions for Pre-eclampsia (CLIP) in India: A cluster randomised controlled trial

• Published in: Pregnancy hypertension 2018-10, Vol.13, p.S35-S35
• Main Authors: Bellad, Mrutyunjaya B., Goudar, Shivaprasad S., Mallapur, Ashalata A., Charantimath, Umesh S., Katageri, Geetanjali S., Sharma, Sumedha, Payne, Beth A., Vidler, Marianne, Li, Jing, Lee, Tang, Bone, Jeffrey, Dunsmuir, Dustin T., Singer, Joel, Wong, Hubert, Ramdurg, Umesh Y., Bannale, Shashidhar, Kavi, Avinash J., Revankar, Amit A., Kodkany, Bhalachandra S., Tu, Domena K., Ansermino, Mark A., Honnungar, Narayan V., Shennan, Andrew H., Bhutta, Zulfiqar A., Magee, Laura A., Dadelszen, Peter von, Clip Trials Working Group
• Format: Article
• Language: English
• ISSN: 2210-7789; 2210-7797
• DOI: 10.1016/j.preghy.2018.08.104

In India, hypertensive disorders of pregnancy cause approximately 7.1% of maternal deaths. Task-sharing pregnancy hypertension-oriented care to community healthcare providers may protect against adverse pregnancy outcomes. To reduce by 20%, one or more of: maternal death/morbidity, stillbirth, or neonatal death/morbidity in the intervention arm. The India Community Level Interventions for Pre-eclampsia (CLIP) cluster randomised controlled trial took place in 12 clusters in Belagavi and Bagalkote, Karnataka (NCT01911494). The CLIP intervention (6 clusters) consisted of community engagement, mobile health-guided home-based pregnancy and postpartum care, initiation of life-saving therapies (MgSO4 or methyldopa) and referral to facility, as appropriate. Data were collected by population-based survey based on the Global Network Maternal and Newborn Health Registry. Treatment effect was estimated by multilevel logistic regression, adjusting for baseline cluster- and individual-level characteristics of prognostic significance. A priori defined secondary analyses included evaluation of temporal and dose-dependent treatment effects. Of 14,777 women recruited (7833 intervention; 6944 control), none were lost to follow-up. The primary outcome did not differ between trial arms (1,249 women, 15.85% vs.1172, 16.88%, respectively; adjusted odds ratio [aOR] 0.93, 95% confidence interval [0.73–1.18], p = 0.62). In both arms, an estimated reduction in the odds of primary outcome of 1.0% per quarter was observed (OR = 0.99, 95% CI [0.99–1.00], p = 0.02). In intervention clusters, the temporal trend-adjusted outcome rate decreased by 8.0% (aOR 0.92 [0.91–0.95], p