Enhancing Nutrition and Antenatal Infection Treatment for Maternal and Child Health in Ethiopia
Status:
Withdrawn
Trial end date:
2021-11-30
Target enrollment:
Participant gender:
Summary
The ENAT study will test the impact of packages of antenatal interventions to enhance
maternal nutrition and manage pregnancy infections on the outcomes of infant birth size,
gestational length, and infant growth in the first 6 months of life. Approximately 5,280
pregnant women will be enrolled into the study from 12 health centers in the Amhara region of
Ethiopia. Routine antenatal care will be strengthened in all health centers, and six health
centers will be randomized to additionally provide a nutritional intervention including daily
multiple-micronutrient or a fortified balanced-energy protein supplement for malnourished
women. Women across all 12 health centers will be individually randomized to receive one of
three infection management interventions in pregnancy: 1) enhanced infection management
package (screening-treatment for urinary tract infections and sexually transmitted
infections, presumptive deworming); 2) presumptive azithromycin (2g at <24 wks and a second
dose at least 4 weeks later); or 3) placebo. The women and their infants will be followed
until 6 months postpartum. Outcomes of interest include birth size (weight, length),
gestational age, maternal weight gain in pregnancy, maternal anemia, antimicrobial
resistance, and infant size at 6 months.
Phase:
Phase 4
Details
Lead Sponsor:
Brigham and Women's Hospital
Collaborators:
Addis Continental Institute of Public Health Amhara Public Health Institute Beth Israel Deaconess Medical Center Boston Children's Hospital Boston Children’s Hospital Harvard School of Public Health Harvard School of Public Health (HSPH) Jhpiego Johns Hopkins Bloomberg School of Public Health
Treatments:
Albendazole Anti-Bacterial Agents Antibiotics, Antitubercular Azithromycin Micronutrients Trace Elements