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

被引：24

作者：

Bellad, Mrutunjaya B. ^{[1
]}

Goudar, Shivaprasad S. ^{[1
]}

Mallapur, Ashalata A. ^{[2
]}

Sharma, Sumedha ^{[3
]}

Bone, Jeffrey ^{[3
]}

Charantimath, Umesh S. ^{[1
]}

Katageri, Geetanjali M. ^{[2
]}

Ramadurg, Umesh Y. ^{[2
]}

Ansermino, J. Mark ^{[4
]}

Derman, Richard J. ^{[5
]}

Dunsmuir, Dustin T. ^{[4
]}

Honnungar, Narayan V. ^{[1
]}

Karadiguddi, Chandrashekhar ^{[1
]}

Kavi, Avinash J. ^{[1
]}

Kodkany, Bhalachandra S. ^{[1
]}

Lee, Tang ^{[3
]}

Li, Jing ^{[3
]}

Nathan, Hannah L. ^{[6
]}

Payne, Beth A. ^{[4
]}

Revankar, Amit P. ^{[1
]}

Shennan, Andrew H. ^{[6
]}

Singer, Joel ^{[7
]}

Tu, Domena K. ^{[3
]}

Vidler, Marianne ^{[3
]}

Wong, Hubert ^{[7
]}

Bhutta, Zulfiqar A. ^{[8
,9
]}

Magee, Laura A. ^{[3
,6
]}

von Dadelszen, Peter ^{[3
,6
]}

机构：

[1] JN Med Coll, KLE Acad Higher Educ & Res, Belagavi 590010, Karnataka, India

[2] HSK Hanagal Shree Kumareshwar Hosp & Res Ctr, S Nijalingappa Med Coll, Bagalkot 587102, Karnataka, India

[3] Univ British Columbia, Fac Med, Dept Obstet & Gynaecol, Suite 930,1125 Howe St, Vancouver, BC V6Z 2K8, Canada

[4] Ctr Int Child Hlth, 305-4088 Cambie St, Vancouver, BC V5Z 2X8, Canada

[5] Thomas Jefferson Univ, Global Affairs, 1020 Walnut St, Philadelphia, PA 19107 USA

[6] Kings Coll London, St Thomas Hosp, Sch Life Course Sci, Dept Women & Childrens Hlth,Fac Life Sci & Med, Westminster Bridge Rd, London SE1 7EH, England

[7] Univ British Columbia, Providence Hlth Care Res Inst, Ctr Hlth Evaluat & Outcome Sci, St Pauls Hosp, 588-1081 Burrard St, Vancouver, BC V6Z 1Y6, Canada

[8] Hosp Sick Children, Ctr Global Child Hlth, 525 Univ Ave,Suite 702, Toronto, ON M5G 2L3, Canada

[9] Aga Khan Univ, Stadium Rd,POB 3500, Karachi 74800, Pakistan

来源：

PREGNANCY HYPERTENSION-AN INTERNATIONAL JOURNAL OF WOMENS CARDIOVASCULAR HEALTH | 2020年 / 21卷

基金：

比尔及梅琳达.盖茨基金会;

关键词：

Cluster randomized controlled trial; Pregnancy hypertension; India; Community engagement; Mobile health; Community health worker; MATERNAL MORTALITY; GUIDELINES;

D O I：

10.1016/j.preghy.2020.05.008

中图分类号：

R71 [妇产科学];

学科分类号：

100211 ;

摘要：

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.

引用

页码：166 / 175

页数：10

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