Enhancing Nutrition and Antenatal Infection Treatment for Maternal and Child Health in Ethiopia

• Status: Withdrawn
• Trial end date: 2021-11-30
• Target enrollment: 0
• Participant gender: Female

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

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

Criteria

Inclusion Criteria:

• Pregnant women <=24 weeks gestation with a viable pregnancy based on a best clinical algorithm (LMP and/or symphysis fundal height)

Exclusion Criteria:

• Pregnant women presenting at enrollment >24 weeks

• Pregnant women presenting with non-viable fetus

• Women who do not intend to deliver in the study catchment area

• Known allergy to Azithromycin or macrolide antibiotic

• Women who refuse to provide consent