Healthy Baby Healthy Mother Toolkit
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-35
SponsorEmory University
About this trial
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
Qualifiers
<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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Healthy Mother Healthy Baby Toolkit
- Standard of care
Treatment groups
594 Participants
are divided into 2 treatment groupsSponsors and collaborators
Emory University
Lead sponsor
Agency Fund and GDI solutions, LLC
Collaborator
Amharic Public Health Institute (APHI)
Collaborator
Source ClinicalTrials.gov