TY - JOUR
T1 - Community-level interventions for pre-eclampsia (CLIP) in Mozambique
T2 - A cluster randomised controlled trial
AU - the CLIP Mozambique Working Group
AU - Sevene, Esperança
AU - Sharma, Sumedha
AU - Munguambe, Khátia
AU - Sacoor, Charfudin
AU - Vala, Anifa
AU - Macuacua, Salésio
AU - Boene, Helena
AU - Mark Ansermino, J.
AU - Augusto, Orvalho
AU - Bique, Cassimo
AU - Bone, Jeffrey
AU - Dunsmuir, Dustin T.
AU - Lee, Tang
AU - Li, Jing
AU - Macete, Eusébio
AU - Singer, Joel
AU - Wong, Hubert
AU - Nathan, Hannah L.
AU - Payne, Beth A.
AU - Sidat, Mohsin
AU - Shennan, Andrew H.
AU - Tchavana, Corssino
AU - Tu, Domena K.
AU - Vidler, Marianne
AU - Bhutta, Zulfiqar A.
AU - Magee, Laura A.
AU - von Dadelszen, Peter
N1 - Funding Information:
The authors would like to thank all participants in the study and the Community Level Interventions for Pre-eclampsia (CLIP) Working Group (Table S1). We gratefully acknowledge the following members of the Data Safety Monitoring Board namely Romano Nkumbwa Byaruhanga, Brian Darlow, Eileen Hutton, and Lehana Thabane, for their data review and recommendations (Table S1). This trial was funded by the University of British Columbia, a grantee of the Bill & Melinda Gates Foundation (PRE-EMPT initiative, grant number OPP1017337). Following input into trial design, the Gates Foundation had no role in data collection, analysis, or interpretation, or writing of the report. PvD, LAM, ZAB, ES, KM, CS, EM, MS, CB, BAP, JMA, AS, HLN conceptualised the Trial and the components of the intervention. ES, KM, CS, AV, SM, HB, OA, EM, MS, BAP, MV, SS co-ordinated activities and monitoring of the Trial. CS, CT, OA, JL, DT, TL, DD were responsible for data collection, transfer and data cleaning. JS, HW, TL, JB performed the analyses. ES, LAM, SS and PvD wrote the first draft of the manuscript. All authors provided feedback and review of the manuscript.
Funding Information:
This trial was funded by the University of British Columbia , a grantee of the Bill & Melinda Gates Foundation (PRE-EMPT initiative, grant number OPP1017337 ). Following input into trial design, the Gates Foundation had no role in data collection, analysis, or interpretation, or writing of the report.
Publisher Copyright:
© 2020 The Authors
PY - 2020/7
Y1 - 2020/7
N2 - Objectives: Pregnancy hypertension is the third leading cause of maternal mortality in Mozambique and contributes significantly to fetal and neonatal mortality. 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 Mozambique Community-Level Interventions for Pre-eclampsia (CLIP) cluster randomised controlled trial (NCT01911494) recruited pregnant women in 12 administrative posts (clusters) in Maputo and Gaza Provinces. The CLIP intervention (6 clusters) consisted of community engagement, community health worker-provided mobile health-guided clinical assessment, initial treatment, and referral to facility either urgently (<4hrs) or non-urgently (<24hrs), 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 CLIP contacts. Main outcome measures: 20% reduction in composite of maternal, fetal, and newborn mortality and major morbidity. Results: 15,013 women (15,123 pregnancies) were recruited in intervention (N = 7930; 2·0% loss to follow-up (LTFU)) and control (N = 7190; 2·8% LTFU) clusters. The primary outcome did not differ between intervention and control clusters (adjusted odds ratio (aOR) 1·31, 95% confidence interval (CI) [0·70, 2·48]; p = 0·40). Compared with intervention arm women without CLIP contacts, those with ≥8 contacts experienced fewer primary outcomes (aOR 0·79 (95% CI 0·63, 0·99); p = 0·041), primarily due to improved maternal outcomes (aOR 0·72 (95% CI 0·53, 0·97); p = 0·033). Interpretation: As generally implemented, the CLIP intervention did not improve pregnancy outcomes; community implementation of the WHO eight contact model may be beneficial. Funding: The University of British Columbia (PRE-EMPT), a grantee of the Bill & Melinda Gates Foundation (OPP1017337).
AB - Objectives: Pregnancy hypertension is the third leading cause of maternal mortality in Mozambique and contributes significantly to fetal and neonatal mortality. 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 Mozambique Community-Level Interventions for Pre-eclampsia (CLIP) cluster randomised controlled trial (NCT01911494) recruited pregnant women in 12 administrative posts (clusters) in Maputo and Gaza Provinces. The CLIP intervention (6 clusters) consisted of community engagement, community health worker-provided mobile health-guided clinical assessment, initial treatment, and referral to facility either urgently (<4hrs) or non-urgently (<24hrs), 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 CLIP contacts. Main outcome measures: 20% reduction in composite of maternal, fetal, and newborn mortality and major morbidity. Results: 15,013 women (15,123 pregnancies) were recruited in intervention (N = 7930; 2·0% loss to follow-up (LTFU)) and control (N = 7190; 2·8% LTFU) clusters. The primary outcome did not differ between intervention and control clusters (adjusted odds ratio (aOR) 1·31, 95% confidence interval (CI) [0·70, 2·48]; p = 0·40). Compared with intervention arm women without CLIP contacts, those with ≥8 contacts experienced fewer primary outcomes (aOR 0·79 (95% CI 0·63, 0·99); p = 0·041), primarily due to improved maternal outcomes (aOR 0·72 (95% CI 0·53, 0·97); p = 0·033). Interpretation: As generally implemented, the CLIP intervention did not improve pregnancy outcomes; community implementation of the WHO eight contact model may be beneficial. 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 - Mozambique
KW - Pregnancy hypertension
UR - http://www.scopus.com/inward/record.url?scp=85085282316&partnerID=8YFLogxK
U2 - 10.1016/j.preghy.2020.05.006
DO - 10.1016/j.preghy.2020.05.006
M3 - Article
C2 - 32464527
AN - SCOPUS:85085282316
SN - 2210-7789
VL - 21
SP - 96
EP - 105
JO - Pregnancy Hypertension
JF - Pregnancy Hypertension
ER -
