The CLIP (Community Level Interventions for Pre-eclampsia) Cluster Randomized Controlled Trial

Completed Not Applicable NCT01911494

Study Description

This project is being undertaken to test the hypothesis that implementing a community based package of care for women with hypertensive disorders of pregnancy will result in overall improvement in maternal and neonatal outcomes. This is based on the premise that there are three main modifiable reasons why women (and their fetuses/newborns) die due to pregnancy complications: 1) delays by the woman herself in recognizing the seriousness of her condition; 2) delays in her being assessed and then transported to a center capable of providing effective and life-saving interventions; and 3) delays in the health facility in providing those interventions. The treatments for pre-eclampsia that are poorly accessed in LMIC are 1) magnesium sulfate (MgSO4) for prevention and treatment of the grand mal seizures of eclampsia; 2) oral antihypertensive medication to lower maternal BP to reduce the risk of stroke. The CLIP pilot and definitive cRCT will investigate whether the community level intervention including implementation of the CLIP package (oral antihypertensive therapy when indicated, intramuscular (i.m.) MgSO4 when indicated; and appropriate referral to an CEmOC facility when indicated) of care will reduce the incidence of all-cause maternal morbidity and mortality.

Study Details

Registry ID:
NCT01911494
Conditions:
Pre-eclampsia, Hypertension, Pregnancy Induced
Phase:
Not Applicable
Target Enrollment:
87,500 participants
Start Date:
Age Range:
15–49 years
Gender:
Female
Healthy Volunteers:
No

Study Locations (4 sites)

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