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

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Community level interventions for pre-eclampsia (CLIP) in India : A cluster randomised controlled trial. / the CLIP India Working Group (Table S1).

In: Pregnancy Hypertension, Vol. 21, 07.2020, p. 166-175.

Research output: Contribution to journalArticle

Harvard

the CLIP India Working Group (Table S1) 2020, 'Community level interventions for pre-eclampsia (CLIP) in India: A cluster randomised controlled trial', Pregnancy Hypertension, vol. 21, pp. 166-175. https://doi.org/10.1016/j.preghy.2020.05.008

APA

the CLIP India Working Group (Table S1) (2020). Community level interventions for pre-eclampsia (CLIP) in India: A cluster randomised controlled trial. Pregnancy Hypertension, 21, 166-175. https://doi.org/10.1016/j.preghy.2020.05.008

Vancouver

the CLIP India Working Group (Table S1). Community level interventions for pre-eclampsia (CLIP) in India: A cluster randomised controlled trial. Pregnancy Hypertension. 2020 Jul;21:166-175. https://doi.org/10.1016/j.preghy.2020.05.008

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the CLIP India Working Group (Table S1). / Community level interventions for pre-eclampsia (CLIP) in India : A cluster randomised controlled trial. In: Pregnancy Hypertension. 2020 ; Vol. 21. pp. 166-175.

Bibtex Download

@article{56a68f11b59d4bda9ed5c646b3031a75,
title = "Community level interventions for pre-eclampsia (CLIP) in India: A cluster randomised controlled trial",
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",
author = "{the CLIP India Working Group (Table S1)} and Bellad, {Mrutunjaya B.} and Goudar, {Shivaprasad S.} and Mallapur, {Ashalata A.} and Sumedha Sharma and Jeffrey Bone and Charantimath, {Umesh S.} and Katageri, {Geetanjali M.} and Ramadurg, {Umesh Y.} and {Mark Ansermino}, J. and Derman, {Richard J.} and Dunsmuir, {Dustin T.} and Honnungar, {Narayan V.} and Chandrashekhar Karadiguddi and Kavi, {Avinash J.} and Kodkany, {Bhalachandra S.} and Tang Lee and Jing Li and Nathan, {Hannah L.} and Payne, {Beth A.} and Revankar, {Amit P.} and Shennan, {Andrew H.} and Joel Singer and Tu, {Domena K.} and Marianne Vidler and Hubert Wong and Bhutta, {Zulfiqar A.} and Magee, {Laura A.} and {von Dadelszen}, Peter",
year = "2020",
month = jul,
doi = "10.1016/j.preghy.2020.05.008",
language = "English",
volume = "21",
pages = "166--175",
journal = "Pregnancy Hypertension",
issn = "2210-7789",
publisher = "Elsevier BV",

}

RIS (suitable for import to EndNote) Download

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

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

VL - 21

SP - 166

EP - 175

JO - Pregnancy Hypertension

JF - Pregnancy Hypertension

SN - 2210-7789

ER -

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