Status:
RECRUITING
Healthy Baby Healthy Mother Toolkit
Lead Sponsor:
Emory University
Collaborating Sponsors:
Agency Fund and GDI solutions, LLC
Amharic Public Health Institute (APHI)
Conditions:
Maternal Nutrition
Child Nutrition
Eligibility:
FEMALE
18-35 years
Phase:
NA
Brief Summary
The objective of the research is to test whether integrating a mother-baby nutrition toolkit into routine antenatal care service can improve maternal and infant nutrition in Amhara, Ethiopia
Detailed Description
The high burden of undernutrition through the critical first 1,000 days persists in Ethiopia. Studies have indicated that approximately 1 in 4 women of reproductive age in Ethiopia are underweight, 17...
Eligibility Criteria
Inclusion
- \<20 weeks gestation as determined by maternal report of last menstrual period
- Intending to breastfeed and provide age-appropriate complementary feeding
- Intend to continue services at the health center where they enrolled until their infant is at least 10 months old
Exclusion
- Women who participated in the formative phase of the HMHBT project
- Women with an existing medical condition that merits precautions for a high-risk pregnancy and may affect study outcomes independently of the intervention. These include for example, uncontrolled or advanced diabetes, advanced kidney disease (stage 3 or higher); thyroid disease, autoimmune disorders such as lupus, moderate to severe rheumatoid arthritis, organ transplant; blood clotting or bleeding disorders, multiple sclerosis.
- Women with a history of previous preterm delivery (\<32w) or very low birth weight babies (\<1.5kg)
- Known history of serious obstetric complications that place the mother at increased risk for subsequent adverse events or complications. These include for example multiple miscarriages or stillbirths (\>2); eclampsia, hemorrhage, placenta previa, placental abruption, uterine rupture
- Women experiencing pregnancy loss, and neonatal or infant mortality will be excluded from further follow-up. Women who give birth to multiples will be retained but their data will be analyzed separately
Key Trial Info
Start Date :
November 27 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
594 Patients enrolled
Trial Details
Trial ID
NCT06594419
Start Date
November 27 2024
End Date
April 1 2026
Last Update
March 24 2025
Active Locations (2)
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1
Emory University in Ethiopia
Bahir Dar, Amhara, Ethiopia
2
Bahir Dar City Zone Health Department
Bahir Dar, Woreda, Ethiopia