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Randomized Controlled Trial
. 2020 Jul:21:166-175.
doi: 10.1016/j.preghy.2020.05.008. Epub 2020 May 19.

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

Mrutunjaya B Bellad  1 , Shivaprasad S Goudar  2 , Ashalata A Mallapur  3 , Sumedha Sharma  4 , Jeffrey Bone  4 , Umesh S Charantimath  2 , Geetanjali M Katageri  3 , Umesh Y Ramadurg  3 , J Mark Ansermino  5 , Richard J Derman  6 , Dustin T Dunsmuir  5 , Narayan V Honnungar  2 , Chandrashekhar Karadiguddi  2 , Avinash J Kavi  2 , Bhalachandra S Kodkany  2 , Tang Lee  4 , Jing Li  4 , Hannah L Nathan  7 , Beth A Payne  5 , Amit P Revankar  2 , Andrew H Shennan  7 , Joel Singer  8 , Domena K Tu  4 , Marianne Vidler  9 , Hubert Wong  8 , Zulfiqar A Bhutta  10 , Laura A Magee  11 , Peter von Dadelszen  11 ; CLIP India Working Group (Table S1)
Affiliations
Randomized Controlled Trial

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

Mrutunjaya B Bellad et al. Pregnancy Hypertens. 2020 Jul.

Abstract

Objectives: 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.

Study design: 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.

Main outcome measures: 20% reduction in composite of maternal, fetal, and newborn mortality and major morbidity.

Results: 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).

Conclusions: As implemented, solely community-level interventions focussed on pre-eclampsia did not improve outcomes in northwest Karnataka.

Keywords: Cluster randomized controlled trial; Community engagement; Community health worker; India; Mobile health; Pregnancy hypertension.

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Conflict of interest statement

Declaration of Interests We declare no competing interests. BAP, LAM and PvD acknowledge that the intellectual property related to the miniPIERS prediction model used in the CLIP trials was transferred in its entirety from the University of British Columbia to them, among other inventors, prior to the trial. They have no financial benefit from the use of the model based on the transfer.

Figures

Fig. 1
Fig. 1
Map of study area and enrollment by cluster.
Fig. 2
Fig. 2
Trial profile – Intervention vs. control allocation clusters.
Supplementary figure 1
Supplementary figure 1
Supplementary figure 2
Supplementary figure 2
See this image and copyright information in PMC

References

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