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Recruiting NCT06594419

NCT06594419 Healthy Baby Healthy Mother Toolkit

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Clinical Trial Summary
NCT ID NCT06594419
Status Recruiting
Phase
Sponsor Emory University
Condition Maternal Nutrition
Study Type INTERVENTIONAL
Enrollment 594 participants
Start Date 2024-11-27
Primary Completion 2026-04

Eligibility & Interventions

Sex Female only
Min Age 18 Years
Max Age 35 Years
Study Type INTERVENTIONAL
Interventions
Healthy Mother Healthy Baby ToolkitStandard of care

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 594 participants in total. It began in 2024-11-27 with a primary completion date of 2026-04.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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

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

Contact & Investigator

Central Contact

Amy Webb Girard, PhD BSN

✉ awebb3@emory.edu

📞 404-727-8807

Principal Investigator

Amy Webb Girard, PhD BSN

PRINCIPAL INVESTIGATOR

Rollins School of Public Health

Frequently Asked Questions

Who can join the NCT06594419 clinical trial?

This trial is open to female participants only, aged 18 Years or older, up to 35 Years, studying Maternal Nutrition. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06594419 currently recruiting?

Yes, NCT06594419 is actively recruiting participants. Contact the research team at awebb3@emory.edu for enrollment information.

Where is the NCT06594419 trial being conducted?

This trial is being conducted at Bahir Dar, Ethiopia, Bahir Dar, Ethiopia.

Who is sponsoring the NCT06594419 clinical trial?

NCT06594419 is sponsored by Emory University. The principal investigator is Amy Webb Girard, PhD BSN at Rollins School of Public Health. The trial plans to enroll 594 participants.

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