TY - JOUR
T1 - Community-level interventions for pre-eclampsia (CLIP) in Pakistan
T2 - A cluster randomised controlled trial
AU - the CLIP Pakistan Working Group
AU - Qureshi, Rahat N.
AU - Sheikh, Sana
AU - Hoodbhoy, Zahra
AU - Sharma, Sumedha
AU - Vidler, Marianne
AU - Payne, Beth A.
AU - Ahmed, Imran
AU - Mark Ansermino, J.
AU - Bone, Jeffrey
AU - Dunsmuir, Dustin T.
AU - Lee, Tang
AU - Li, Jing
AU - Nathan, Hannah L.
AU - Shennan, Andrew H.
AU - Singer, Joel
AU - Tu, Domena K.
AU - Wong, Hubert
AU - Magee, Laura A.
AU - von Dadelszen, Peter
AU - Bhutta, Zulfiqar A.
PY - 2020/10
Y1 - 2020/10
N2 - 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).
AB - 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).
KW - Cluster randomized controlled trial
KW - Community engagement
KW - Community health worker
KW - Mobile health
KW - Pakistan
KW - Pregnancy hypertension
UR - http://www.scopus.com/inward/record.url?scp=85089148255&partnerID=8YFLogxK
U2 - 10.1016/j.preghy.2020.07.011
DO - 10.1016/j.preghy.2020.07.011
M3 - Article
AN - SCOPUS:85089148255
SN - 2210-7789
VL - 22
SP - 109
EP - 118
JO - Pregnancy Hypertension
JF - Pregnancy Hypertension
ER -