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

• Published in: Pregnancy hypertension Vol. 21; pp. 166 - 175
• Main Authors: Bellad, Mrutunjaya B., Goudar, Shivaprasad S., Mallapur, Ashalata A., Sharma, Sumedha, Bone, Jeffrey, Charantimath, Umesh S., Katageri, Geetanjali M., Ramadurg, Umesh Y, Mark Ansermino, J., Derman, Richard J., Dunsmuir, Dustin T., Honnungar, Narayan V., Karadiguddi, Chandrashekhar, Kavi, Avinash J., Kodkany, Bhalachandra S., Lee, Tang, Li, Jing, Nathan, Hannah L., Payne, Beth A., Revankar, Amit P., Shennan, Andrew H., Singer, Joel, Tu, Domena K., Vidler, Marianne, Wong, Hubert, Bhutta, Zulfiqar A., Magee, Laura A., von Dadelszen, Peter
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier B.V 01.07.2020; Elsevier
• Subjects: Cluster randomized controlled trial; Community engagement; Community health worker; India; Mobile health; Pregnancy hypertension; Community health worker; Community engagement; Pregnancy hypertension; Mobile health; Cluster randomized controlled trial; India
• ISSN: 2210-7789; 2210-7797
• DOI: 10.1016/j.preghy.2020.05.008

•As implemented, the CLIP intervention did not improve the primary composite outcome.•ASHAs and ANMs were able to undertake all aspects of the mobile health app-guided visits.•Women could not be reached in their communities as frequently as planned.•Eight or more POM-guided contacts were associated with fewer stillbirths supporting WHO guidance.•Community-level interventions are unlikely to improve outcomes without enhanced facility care. Pregnancy hypertension is associated with 7.1% of maternal deaths in India. The objective of this trial was to assess whether task-sharing care might reduce adverse pregnancy outcomes related to delays in triage, transport, and treatment. The Indian Community-Level Interventions for Pre-eclampsia (CLIP) open-label cluster randomised controlled trial (NCT01911494) recruited pregnant women in 12 clusters (initial four-cluster internal pilot) in Belagavi and Bagalkote, Karnataka. The CLIP intervention (6 clusters) consisted of community engagement, community health workers (CHW) provided mobile health (mHeath)-guided clinical assessment, initial treatment, and referral to facility either urgently (<4 h) or non-urgently (<24 h), dependent on algorithm-defined risk. Treatment effect was estimated by multi-level logistic regression modelling, adjusted for prognostically-significant baseline variables. Predefined secondary analyses included safety and evaluation of the intensity of mHealth-guided CHW-provided contacts. 20% reduction in composite of maternal, fetal, and newborn mortality and major morbidity. All 14,783 recruited pregnancies (7839 intervention, 6944 control) were followed-up. The primary outcome did not differ between intervention and control arms (adjusted odds ratio (aOR) 0.92 [95% confidence interval 0.74, 1.15]; p = 0.47; intraclass correlation coefficient 0.013). There were no intervention-related safety concerns following administration of either methyldopa or MgSO4, and 401 facility referrals. Compared with intervention arm women without CLIP contacts, those with ≥8 contacts suffered fewer stillbirths (aOR 0.19 [0.10, 0.35]; p < 0.001), at the probable expense of survivable neonatal morbidity (aOR 1.39 [0.97, 1.99]; p = 0.072). As implemented, solely community-level interventions focussed on pre-eclampsia did not improve outcomes in northwest Karnataka.