NCT04171388

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

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

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Low Birthweight
• Preterm Birth
• Maternal; Malnutrition, Affecting Fetus
• Sexually Transmitted Diseases
• Urinary Tract Infections
• Pregnancy and Infectious Disease

Interventions

Type	Name	Description
DRUG	Azithromycin 500 mg	Azithromycin 500mg (Kern Pharma): 2g (4 tablets) at 2 time points during pregnancy: enrollment (\<=24 weeks gestation), and follow-up ANC at least 4 weeks later
DIETARY_SUPPLEMENT	Multiple Micronutrient or Fortified Balanced Energy Protein Supplement	Daily multiple micronutrient (MMN) tablet (Contract Pharmacal Corp) for women with mid-upper arm circumference (MUAC) \>=23 cm, OR Daily fortified balanced energy protein (BEP) supplement (DSM South Africa; Faffa Food Products): Fortified corn-soy blend (784 kcal/day) for women with MUAC \<23 cm
DRUG	Placebo oral tablet 500 mg	Placebo 500mg (Idifarma): 2g (4 tablets) at 2 time points during pregnancy; enrollment (\<24 weeks gestation), and follow up ANC at least 4 weeks later
OTHER	Enhanced Infection Management Package (EIMP)	ENROLLMENT VISIT: Screening for bacteriuria with urine culture, and antimicrobial susceptibility testing; Screening for chlamydia and gonorrhea with Cepheid GeneXpert; Presumptive deworming with albendazole 500mg. FOLLOWUP TREATMENT VISIT: For women with identified urinary tract infection or asymptomatic bacteriuria, treatment with antibiotics based on antimicrobial susceptibility patterns. For women with identified chlamydia or gonorrhea, treatment of woman (and partner) with appropriate antibiotics. Test of cure sample and retreatment of infection. Second deworming with albendazole at least 4 weeks after enrollment ANC visit.

Timeline

• Start date: 2020-03-01
• Primary completion: 2021-05-28
• Completion: 2021-11-30
• First posted: 2019-11-20
• Last updated: 2020-08-17