Community Level Interventions for Pre-eclampsia

NACompletedINTERVENTIONAL
Enrollment

87,500

Participants

Timeline

Start Date

September 30, 2013

Primary Completion Date

May 31, 2018

Study Completion Date

June 30, 2018

Conditions
Pre-eclampsiaHypertension, Pregnancy Induced
Interventions
BEHAVIORAL

Community Engagement

The primary objective of the community engagement activities in CLIP will be to create awareness and action around the prevention of maternal morbidity and mortality due to pre-eclampsia/eclampsia. Community engagement involves the collective action of individuals, families, religious leaders, policy makers,

DEVICE

PIERS on the Move mHealth decision aid

This mHealth application is to be used by community health workers in intervention clusters to guide collection of relevant clinical data during antenatal visits. This clinical data is used to generate a risk estimate for any women with hypertension based on the miniPIERS (Pre-eclampsia Integrated Estimate of Risk) clinical risk prediction model. This risk estimate in combination with other pre-defined treatment triggers (severe hypertension (\>160mmHg systolic) or proteinuria (\>3+ dipstick); absence of fetal movements for greater than 12 hours; signs of recent stroke of seizure) are collected in the app and based on this data recommendations for care of the woman are provided.

DRUG

Magnesium Sulfate

Women identified in intervention clusters by the community health worker during a study visit as being at high risk of- or having recently experienced- an eclamptic seizure will be given 10 g intramuscular magnesium sulfate prior to transfer to a nearby facility for further care.

DRUG

Methyldopa

Women identified in intervention clusters as having severe hypertension (systolic greater than 160 mmHg) by the community health worker during a study visit will be given 750 mg of oral methyldopa prior to transfer to a nearby facility for further care.

Trial Locations (4)

Unknown

Jawaharlal Nehru Medical College, Karnataka Lingayat Education University, Belagavi

Centro de Investigacaoem Saude de Manhica (CISM), Maputo

Centre for Research in Reproductive Health, Olabisi Onabanjo University, Sagamu

Aga Khan University, Karachi

All Listed Sponsors
collaborator

Bill and Melinda Gates Foundation

OTHER

collaborator

Olabisi Onabanjo University

OTHER

collaborator

Centro de Investigacao em Saude de Manhica

OTHER

collaborator

Aga Khan University

OTHER

collaborator

Jawaharlal Nehru Medical College

OTHER

lead

University of British Columbia

OTHER

NCT01911494 - Community Level Interventions for Pre-eclampsia | Biotech Hunter | Biotech Hunter