Healthy Baby Healthy Mother Toolkit
Launched by EMORY UNIVERSITY · Sep 10, 2024
Trial Information
Current as of July 01, 2025
Recruiting
Keywords
ClinConnect Summary
The Healthy Baby Healthy Mother Toolkit trial is studying whether a special nutrition toolkit for mothers and babies can help improve the health of both during pregnancy and early infancy in Amhara, Ethiopia. This toolkit will be added to regular antenatal care (the care you receive during pregnancy) to help mothers get the right nutrition for themselves and their babies. The trial is currently recruiting women who are less than 20 weeks pregnant, plan to breastfeed, and intend to continue visiting the health center for at least 10 months after their baby is born.
To participate, women must be healthy and not have certain medical conditions that could complicate their pregnancy or the study's results. During the trial, participants will receive guidance and support related to nutrition, which can help them provide better care for themselves and their babies. It's also important to know that women who have experienced serious pregnancy complications or losses in the past may not be eligible to take part in this study. This trial aims to create a healthier future for both mothers and their children through better nutrition.
Gender
FEMALE
Eligibility criteria
- Inclusion Criteria:
- • \<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 Criteria:
- • 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
About Emory University
Emory University, a leading research institution located in Atlanta, Georgia, is dedicated to advancing medical knowledge and improving patient care through innovative clinical trials. With a strong emphasis on interdisciplinary collaboration, Emory harnesses the expertise of its renowned faculty and state-of-the-art facilities to conduct cutting-edge research across various fields, including oncology, neurology, and infectious diseases. The university's commitment to ethical research practices and patient safety ensures that all clinical trials are designed to generate valuable data that can lead to significant therapeutic advancements. By fostering partnerships with local hospitals and community organizations, Emory strives to translate research findings into real-world applications, ultimately enhancing health outcomes for diverse populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Bahir Dar, Amhara, Ethiopia
Bahir Dar, Woreda, Ethiopia
Patients applied
Trial Officials
Amy Webb Girard, PhD BSN
Principal Investigator
Rollins School of Public Health
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported