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NCT Number: NCT06125860

BEP Targeting Strategies in Ethiopia

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Small for Gestational Age at Delivery Birth Weight Body Weight Body Weight Changes Death Female Urogenital Diseases and Pregnancy Complications Fetal Death Gestational Weight Gain Maternal Anemia in Pregnancy, Before Birth Neonatal Death Obstetric Labor Complications Obstetric Labor, Premature Pathologic Processes Pathological Conditions, Signs and Symptoms Perinatal Death Pregnancy Complications Premature Birth Preterm Birth Signs and Symptoms Stillbirth Urogenital Diseases Weight Gain

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Addis Continental Institute of Public Health (ACIPH)

Addis Ababa, Box 26751/1000, Ethiopia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • pregnant women aged 18 to 49;
  • attending antenatal visits in one of the study health facilities;
  • with a gestational age of 24 weeks or less;
  • no known allergies to peanuts or soybeans;
  • having resided in the current location for at least 6 months;
  • intending to continue antenatal follow-up in the health facility;
  • intending to give birth and remain in the study area until six weeks after delivery; and
  • 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

Treatment and study plan

Targeted BEP based on baseline nutritional status

Dietary Supplement

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

Dietary Supplement

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

Dietary Supplement

In Arm 4 (universal BEP), all participants will receive BEP supplements from baseline through the end of pregnancy.

Primary outcomes

  1. Small-for-gestational-age births

    Time frame: Assessed within 72 hours of birth

    Live birth whose birthweight for sex and gestational age is < 10th percentile based on the INTERGROWTH-21st standards

Secondary outcomes

  1. Inadequate gestational weight gain

    Time frame: At the last weight measurement before delivery, at around 36 weeks

    Gestational weight gain percent adequacy ratio less than 90% at the last weight measurement before delivery, based on the Institute of Medicine recommendations

  2. Excessive gestational weight gain

    Time frame: At the last weight measurement before delivery, at around 36 weeks

    Gestational weight gain percent adequacy ratio greater than 125% at the last weight measurement before delivery, based on the Institute of Medicine recommendations

  3. Stillbirth

    Time frame: Between 28 weeks of gestation and delivery

    Fetal death between 28 weeks of gestation and delivery

  4. Preterm birth

    Time frame: Less than 37 completed weeks of gestation

    Live birth < 37 completed weeks of gestation

  5. Low birthweight

    Time frame: Assessed within 72 hours of birth

    Live birth weighing < 2500 grams

  6. Macrosomia

    Time frame: Assessed within 72 hours of birth

    Live birth weighing > 4000 grams

  7. Large-for-gestational-age births

    Time frame: Assessed within 72 hours of birth

    Live birth whose birthweight for sex and gestational age is > 90th percentile based on the INTERGROWTH-21st standards

  8. Third-trimester anemia

    Time frame: At 32 weeks of gestation

    Hemoglobin concentration < 11 g/dL at 32 weeks of gestation

  9. Neonatal death

    Time frame: From birth through 28 days of life

    Death of live newborn < 28 days of life

  10. Perinatal death

    Time frame: Between 28 weeks of gestation to 7 days after delivery

    Fetal death between 28 weeks gestational age and delivery, or newborn death < 7 days of life

  11. Pre-eclampsia

    Time frame: After 20 weeks of gestation

    New onset hypertension (systolic blood pressure >= 140 or diastolic blood pressure >=90 mmhg) after 20 weeks of gestation with proteinuria.

Sponsors and collaborators

Lead sponsor

Harvard School of Public Health (HSPH)

Other

Collaborators

  • Addis Continental Institute of Public Health
  • George Mason University

Registry information

Official study title

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

Acronym: BEP

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Nov 9, 2023
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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