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• W2893664248 abstract "• 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 MgSO 4 , 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." @default.
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• W2893664248 date "2020-07-01" @default.
• W2893664248 modified "2023-10-18" @default.
• W2893664248 title "Community level interventions for pre-eclampsia (CLIP) in India: A cluster randomised controlled trial" @default.
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• W2893664248 doi "https://doi.org/10.1016/j.preghy.2020.05.008" @default.
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