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

Rahat N Qureshi; Sana Sheikh; Zahra Hoodbhoy; Sumedha Sharma; Marianne Vidler; Beth A Payne; Imran Ahmed; J Mark Ansermino; Jeffrey Bone; Dustin T Dunsmuir; Tang Lee; Jing Li; Hannah L Nathan; Andrew H Shennan; Joel Singer; Domena K Tu; Hubert Wong; Laura A Magee; Peter von Dadelszen; Zulfiqar A Bhutta; CLIP Pakistan Working Group

doi:10.1016/j.preghy.2020.07.011

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

Pregnancy Hypertens. 2020 Oct:22:109-118. doi: 10.1016/j.preghy.2020.07.011. Epub 2020 Jul 28.

Authors

Rahat N Qureshi¹, Sana Sheikh¹, Zahra Hoodbhoy¹, Sumedha Sharma², Marianne Vidler³, Beth A Payne⁴, Imran Ahmed¹, J Mark Ansermino⁴, Jeffrey Bone², Dustin T Dunsmuir⁴, Tang Lee², Jing Li², Hannah L Nathan⁵, Andrew H Shennan⁵, Joel Singer⁶, Domena K Tu², Hubert Wong⁶, Laura A Magee⁷, Peter von Dadelszen⁷, Zulfiqar A Bhutta⁸; CLIP Pakistan Working Group⁹

Affiliations

¹ Centre of Excellence, Division of Woman and Child Health, Aga Khan University, Stadium Road, P. O. Box 3500, Karachi 74800, Pakistan.
² Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.
³ Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada; Centre for International Child Health, University of British Columbia, 305-4088 Cambie Street, Vancouver, BC V5Z 2X8, Canada.
⁴ Centre for International Child Health, University of British Columbia, 305-4088 Cambie Street, Vancouver, BC V5Z 2X8, Canada.
⁵ Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Palace Road, London SE1 7EH, UK.
⁶ Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, 588 - 1081 Burrard Street, St. Paul's Hospital, Vancouver, BC V6Z 1Y6, Canada.
⁷ Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Palace Road, London SE1 7EH, UK.
⁸ Centre of Excellence, Division of Woman and Child Health, Aga Khan University, Stadium Road, P. O. Box 3500, Karachi 74800, Pakistan; Centre for Global Child Health, Hospital for Sick Children, 525 University Avenue, Suite 702, Toronto, ON M5G 2L3, Canada. Electronic address: zulfiqar.bhutta@aku.edu.
⁹ the CLIP Pakistan Trial Working Group (Table S1).

Abstract

Objectives: To reduce all-cause maternal and perinatal mortality and major morbidity through Lady Health Worker (LHW)-facilitated community engagement and early diagnosis, stabilization and referral of women with preeclampsia, an important contributor to adverse maternal and perinatal outcomes given delays in early detection and initial management.

Study design: In the Pakistan Community-Level Interventions for Pre-eclampsia (CLIP) cluster randomized controlled trial (NCT01911494), LHWs engaged the community, recruited pregnant women from 20 union councils (clusters), undertook mobile health-guided clinical assessment for preeclampsia, and referral to facilities after stabilization.

Main outcome measures: The primary outcome was a composite of maternal, fetal and newborn mortality and major morbidity.

Findings: We recruited 39,446 women in intervention (N = 20,264) and control clusters (N = 19,182) with minimal loss to follow-up (3∙7% vs. 4∙5%, respectively). The primary outcome did not differ between intervention (26·6%) and control (21·9%) clusters (adjusted odds ratio, aOR, 1∙20 [95% confidence interval 0∙84-1∙72]; p = 0∙31). There was reduction in stillbirths (0·89 [0·81-0·99]; p = 0·03), but no impact on maternal death (1·08 [0·69, 1·71]; p = 0·74) or morbidity (1·12 [0·57, 2·16]; p = 0·77); early (0·95 [0·82-1·09]; p = 0·46) or late neonatal deaths (1·23 [0·97-1·55]; p = 0·09); or neonatal morbidity (1·22 [0·77, 1·96]; p = 0·40). Improvements in outcome rates were observed with 4-7 (p = 0·015) and ≥8 (p < 0·001) (vs. 0) CLIP contacts.

Interpretation: The CLIP intervention was well accepted by the community and implemented by LHWs. Lack of effects on adverse outcomes could relate to quality care for mothers with pre-eclampsia in health facilities. Future strategies for community outreach must also be accompanied by health facility strengthening.

Funding: The University of British Columbia (PRE-EMPT), a grantee of the Bill & Melinda Gates Foundation (OPP1017337).

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

Publication types

Multicenter Study
Randomized Controlled Trial

MeSH terms

Adult
Cluster Analysis
Community Health Workers / organization & administration*
Female
Humans
Infant
Infant, Newborn
Maternal Mortality
Pakistan
Pre-Eclampsia / therapy*
Pregnancy
Pregnancy Outcome / epidemiology*
Prenatal Care / statistics & numerical data*
Young Adult