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 - 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 -