Community Level Interventions for Pre-eclampsia

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01911494
• Date of registration: 28/06/2013
• Prospective Registration: Yes
• Primary sponsor: University of British Columbia
• Public title: Community Level Interventions for Pre-eclampsia CLIP
• Scientific title: The CLIP (Community Level Interventions for Pre-eclampsia) Cluster Randomized Controlled Trial
• Date of first enrolment: September 2013
• Target sample size: 87500
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01911494
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

India, Mozambique, Nigeria, Pakistan

Contacts

• Name: Peter von Dadelszen, MBChB, DPhil
• Affiliation: University of British Columbia

Key inclusion & exclusion criteria

Inclusion Criteria:

- all consenting pregnant women

Exclusion Criteria:

- non-pregnant



Age minimum: 15 Years
Age maximum: 49 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Hypertension, Pregnancy Induced

Pre-eclampsia

Intervention(s)

Drug: Methyldopa

Behavioral: Community Engagement

Device: PIERS on the Move mHealth decision aid

Drug: Magnesium Sulfate

Primary Outcome(s)

Maternal or Perinatal death or morbidity [Time Frame: within 42 days of pregnancy]

Secondary Outcome(s)

Facility births [Time Frame: from 20 weeks gestation to delivery]

Birth preparedness and complication readiness [Time Frame: from 20 weeks gestation to delivery]

Secondary ID(s)

H12-03497

F12-01593

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Centro de Investigacao em Saude de Manhica

Jawaharlal Nehru Medical College

Aga Khan University

Bill and Melinda Gates Foundation

Olabisi Onabanjo University