Clinical trial NCT06125860: BEP Targeting Strategies in Ethiopia
Official title: Targeting Strategies of Antenatal Balanced Energy and Protein Supplementation in Addis Ababa, Ethiopia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Keywords: balanced energy and protein supplementation
food supplementation
antenatal nutrition
maternal nutrition
gestational weight gain
Ethiopia
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
Collaborators: name: Addis Continental Institute of Public Health
name: George Mason University
First posted: 2023-11-09
Enrollment: 6750
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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

Primary outcomes:
measure: Small-for-gestational-age births
timeFrame: Assessed within 72 hours of birth
Secondary outcomes:
measure: Inadequate gestational weight gain
timeFrame: At the last weight measurement before delivery, at around 36 weeks
measure: Excessive gestational weight gain
timeFrame: At the last weight measurement before delivery, at around 36 weeks
measure: Stillbirth
timeFrame: Between 28 weeks of gestation and delivery
measure: Preterm birth
timeFrame: Less than 37 completed weeks of gestation
measure: Low birthweight
timeFrame: Assessed within 72 hours of birth
measure: Macrosomia
timeFrame: Assessed within 72 hours of birth
measure: Large-for-gestational-age births
timeFrame: Assessed within 72 hours of birth
measure: Third-trimester anemia
timeFrame: At 32 weeks of gestation
measure: Neonatal death
timeFrame: From birth through 28 days of life
measure: Perinatal death
timeFrame: Between 28 weeks of gestation to 7 days after delivery
measure: Pre-eclampsia
timeFrame: After 20 weeks of gestation
Other outcomes:
Locations:
city: Addis Ababa
country: Ethiopia
facility: Addis Continental Institute of Public Health (ACIPH)
Study officials:
affiliation: Harvard School of Public Health (HSPH)
name: Wafaie W Fawzi, DrPH, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: Addis Continental Institute of Public Health
name: Yemane Berhane, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: