BEP Targeting Strategies in Ethiopia

Preterm Birth Clinical Trial

— BEP  

Official title:

Targeting Strategies of Antenatal Balanced Energy and Protein Supplementation in Addis Ababa, Ethiopia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06125860
• Other study ID #: IRB22-1245
• Status: Recruiting
• Phase: N/A
• Start date: August 7, 2023
• Est. completion date: November 30, 2025

Study information

• Verified date: November 2023
• Source: Harvard School of Public Health (HSPH)
• Contact: Wafaie W Fawzi, DrPH, MBBS
• Phone: 617-432-7598
• Email: mina[@]hsph.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5400
• Est. completion date: November 30, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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 12 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

Related Conditions & MeSH terms

• Birth Weight
• Body Weight
• Death
• Gestational Weight Gain
• Neonatal Death
• Perinatal Death
• Premature Birth
• Preterm Birth
• Small for Gestational Age at Delivery
• Stillbirth
• Weight Gain

Intervention

Dietary Supplement:
• Targeted BEP based on baseline nutritional status
In Arm 2 (targeted BEP based on baseline nutritional status), in addition to the standard of care, participants will receive BEP supplements if their baseline BMI is less than 18.5 or their baseline mid-upper arm circumference is less than 23 cm.
• Targeted BEP based on baseline nutritional status and monthly GWG monitoring
In Arm 3 (targeted BEP based on baseline nutritional status and monthly GWG monitoring), in addition to the standard of care, participants will receive BEP supplements if their baseline BMI is less than 18.5 or their baseline mid-upper arm circumference is less than 23 cm; participants with an inadequate GWG at a monthly follow-up visit will receive additional BEP supplements.
• Universal BEP
In Arm 4 (universal BEP), all participants will receive BEP supplements from baseline through the end of pregnancy.

Locations

Country	Name	City	State
Ethiopia	Addis Continental Institute of Public Health (ACIPH)	Addis Ababa

Sponsors (3)

Lead Sponsor	Collaborator
Harvard School of Public Health (HSPH)	Addis Continental Institute of Public Health, George Mason University

Country where clinical trial is conducted

Ethiopia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Small-for-gestational-age births	Live birth whose birthweight for sex and gestational age is < 10th percentile based on the INTERGROWTH-21st standards	Assessed within 72 hours of birth
Secondary	Inadequate gestational weight gain	Gestational weight gain percent adequacy ratio less than 90% at the last weight measurement before delivery, based on the Institute of Medicine recommendations	At the last weight measurement before delivery, at around 36 weeks
Secondary	Excessive gestational weight gain	Gestational weight gain percent adequacy ratio greater than 125% at the last weight measurement before delivery, based on the Institute of Medicine recommendations	At the last weight measurement before delivery, at around 36 weeks
Secondary	Stillbirth	Fetal death between 28 weeks of gestation and delivery	Between 28 weeks of gestation and delivery
Secondary	Preterm birth	Live birth < 37 completed weeks of gestation	Less than 37 completed weeks of gestation
Secondary	Low birthweight	Live birth weighing < 2500 grams	Assessed within 72 hours of birth
Secondary	Macrosomia	Live birth weighing > 4000 grams	Assessed within 72 hours of birth
Secondary	Large-for-gestational-age births	Live birth whose birthweight for sex and gestational age is > 90th percentile based on the INTERGROWTH-21st standards	Assessed within 72 hours of birth
Secondary	Third-trimester anemia	Hemoglobin concentration < 11 g/dL at 32 weeks of gestation	At 32 weeks of gestation
Secondary	Neonatal death	Death of live newborn < 28 days of life	From birth through 28 days of life
Secondary	Perinatal death	Fetal death between 28 weeks gestational age and delivery, or newborn death < 7 days of life	Between 28 weeks of gestation to 7 days after delivery
Secondary	Pre-eclampsia	New onset hypertension (systolic blood pressure >= 140 or diastolic blood pressure >=90 mmhg) after 20 weeks of gestation with proteinuria.	After 20 weeks of gestation