TY - JOUR
T1 - Community level interventions for pre-eclampsia (CLIP) in India
T2 - A cluster randomised controlled trial
AU - the CLIP India Working Group (Table S1)
AU - Bellad, Mrutunjaya B.
AU - Goudar, Shivaprasad S.
AU - Mallapur, Ashalata A.
AU - Sharma, Sumedha
AU - Bone, Jeffrey
AU - Charantimath, Umesh S.
AU - Katageri, Geetanjali M.
AU - Ramadurg, Umesh Y.
AU - Mark Ansermino, J.
AU - Derman, Richard J.
AU - Dunsmuir, Dustin T.
AU - Honnungar, Narayan V.
AU - Karadiguddi, Chandrashekhar
AU - Kavi, Avinash J.
AU - Kodkany, Bhalachandra S.
AU - Lee, Tang
AU - Li, Jing
AU - Nathan, Hannah L.
AU - Payne, Beth A.
AU - Revankar, Amit P.
AU - Shennan, Andrew H.
AU - Singer, Joel
AU - Tu, Domena K.
AU - Vidler, Marianne
AU - Wong, Hubert
AU - Bhutta, Zulfiqar A.
AU - Magee, Laura A.
AU - von Dadelszen, Peter
N1 - Funding Information:
We would like to thank the women and their families who contributed data to this trial, in addition to the ASHA and ANMs who deliver care to the most vulnerable populations. Also, we would like to acknowledge the key contributions of the following DSMB members: Romano Nkumbwa Byaruhanga, Brian Darlow, Eileen Hutton (Chair), and Lehana Thabane. This trial was funded by the University of British Columbia, a grantee of the Bill & Melinda Gates Foundation (PRE-EMPT initiative, grant number OPP1017337). Following input into trial design, the Gates Foundation had no role in data collection, analysis, or interpretation, or writing of the report. PvD, SSG, MBB, AM, ZAB, LAM, BP, JMA, AS, HN, BS, BK, RJD conceptualised the trial and components of the intervention. SSG, MBB, AM, GK, UC, UR, AK, SB, CK, NVH, BAP, MV, SS implemented and co-ordinated monitoring of the trial. AR, JL, DKT, DD, TL were responsible for data collection, transfer and data cleaning. JS, HW, TL, JB performed the analyses. SS and PvD wrote the first draft of the manuscript. All authors provided feedback and review of the manuscript. The University of British Columbia (PRE-EMPT), a grantee of the Bill & Melinda Gates Foundation (OPP1017337).
Funding Information:
This trial was funded by the University of British Columbia , a grantee of the Bill & Melinda Gates Foundation ( PRE-EMPT initiative, grant number OPP1017337 ). Following input into trial design, the Gates Foundation had no role in data collection, analysis, or interpretation, or writing of the report.
Publisher Copyright:
© 2020 The Authors
PY - 2020/7
Y1 - 2020/7
N2 - 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.
AB - 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.
KW - Cluster randomized controlled trial
KW - Community engagement
KW - Community health worker
KW - India
KW - Mobile health
KW - Pregnancy hypertension
UR - http://www.scopus.com/inward/record.url?scp=85086362417&partnerID=8YFLogxK
U2 - 10.1016/j.preghy.2020.05.008
DO - 10.1016/j.preghy.2020.05.008
M3 - Article
C2 - 32554291
AN - SCOPUS:85086362417
SN - 2210-7789
VL - 21
SP - 166
EP - 175
JO - Pregnancy Hypertension
JF - Pregnancy Hypertension
ER -