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Completed NCT06125860

BEP Targeting Strategies in Ethiopia

Conditions: Small for Gestational Age at Delivery, Gestational Weight Gain, Stillbirth, Preterm Birth, Birth Weight, Maternal Anemia in Pregnancy, Before Birth, Neonatal Death, Perinatal Death

Sex: Female
Ages: 18 Years – 49 Years
Healthy volunteers: No
Phase: NA
Enrollment: 7851
Sponsor: Harvard School of Public Health (HSPH)

Location: Addis Continental Institute of Public Health (ACIPH) Addis Ababa Addis Ababa

Summary

The goal of this randomized effectiveness study is to evaluate the different targeting strategies for the delivery of balanced energy and protein (BEP) supplements among pregnant women in Addis Ababa, Ethiopia. The main goals of the study are to: 1) determine the effectiveness of two individual-based antenatal BEP targeting strategies for preventing adverse pregnancy outcomes; 2) compare the cost-effectiveness of the universal BEP provision with two individual-based targeting strategies for preventing adverse pregnancy outcomes; and 3) generate implementation evidence regarding the feasibility and acceptability of different antenatal BEP targeting strategies. Pregnant women will be enrolled during pregnancy, assigned to different strategies of BEP supplementation, and followed from pregnancy through six weeks postpartum to evaluate the impacts of different BEP targeting strategies on pregnancy, maternal, and child outcomes.

Eligibility Criteria

Inclusion Criteria: 1. pregnant women aged 18 to 49; 2. attending antenatal visits in one of the study health facilities; 3. with a gestational age of 24 weeks or less; 4. no known allergies to peanuts or soybeans; 5. having resided in the current location for at least 6 months; 6. intending to continue antenatal follow-up in the health facility; 7. intending to give birth and remain in the study area until six weeks after delivery; and 8. willing to take the BEP supplements for the entire duration of the pregnancy if eligible. Exclusion Criteria: * Not meeting all of the inclusion criteria above

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06125860). StuddyBuddy aggregates publicly available trial information.