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Randomized Controlled Trial
. 2020 Oct:22:109-118.
doi: 10.1016/j.preghy.2020.07.011. Epub 2020 Jul 28.

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

Rahat N Qureshi  1 , Sana Sheikh  1 , Zahra Hoodbhoy  1 , Sumedha Sharma  2 , Marianne Vidler  3 , Beth A Payne  4 , Imran Ahmed  1 , J Mark Ansermino  4 , Jeffrey Bone  2 , Dustin T Dunsmuir  4 , Tang Lee  2 , Jing Li  2 , Hannah L Nathan  5 , Andrew H Shennan  5 , Joel Singer  6 , Domena K Tu  2 , Hubert Wong  6 , Laura A Magee  7 , Peter von Dadelszen  7 , Zulfiqar A Bhutta  8 ; CLIP Pakistan Working Group  9
Affiliations
Randomized Controlled Trial

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

Rahat N Qureshi et al. Pregnancy Hypertens. 2020 Oct.

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.

PubMed Disclaimer

Conflict of interest statement

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Fig. 1
Fig. 1
Map of study area and enrollment by cluster.
Fig. 2
Fig. 2
Trial profile – Intervention vs. control allocation clusters.
Supplementary figure 1
Supplementary figure 1
CLIP triggers and treatment.
Supplementary figure 2
Supplementary figure 2
Details of referral type according to CLIP triggers and LHW actions.
Supplementary figure 3
Supplementary figure 3
Relationship between the intensity of POM-guided contacts per pregnancy and outcomes in intervention arm women.
See this image and copyright information in PMC

References

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