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

Mass General Brigham

Status and phase: Withdrawn; Phase 4

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

Treatments: Dietary Supplement: Multiple Micronutrient or Fortified Balanced Energy Protein Supplement; Drug: Azithromycin 500 mg; Drug: Placebo oral tablet 500 mg; Other: Enhanced Infection Management Package (EIMP)

Study type: Interventional

Funder types: Other

Identifiers

NCT04171388

2018P002479

Details and patient eligibility

About

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.

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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0 participants in 6 patient groups, including a placebo group

Routine care: Placebo

Placebo Comparator group

Description:

In all pregnancies presenting at all centers, routine antenatal care will be strengthened: Provision of iron-folic acid and tetanus toxoid vaccine Screening for anemia and blood pressure Screening/treatment of HIV, syphilis, malaria, tuberculosis Placebo tablets will be administered twice in pregnancy: at enrollment (<=24 weeks) and a follow up ANC visit at least 4 weeks later.

Treatment:

Drug: Placebo oral tablet 500 mg

Routine care: Azithromycin

Experimental group

Description:

Azithromycin will be provided twice in pregnancy: at enrollment (<=24 weeks) and a follow up ANC visit at least 4 weeks later.

Treatment:

Drug: Azithromycin 500 mg

Routine care: Enhanced Infection Management Package (EIMP)

Experimental group

Description:

At the study enrollment visit, pregnant women will receive presumptive deworming (albendazole) and screening for urinary tract infection and sexually transmitted infections (chlamydia and gonorrhea). Women with identified infections will be treated with appropriate antibiotics. A second dose of albendazole will be given at a follow up ANC visit at least 4 weeks after enrollment.

Treatment:

Other: Enhanced Infection Management Package (EIMP)

Enhanced Nutrition Package (ENP): Placebo

Experimental group

Description:

Pregnant women will receive a daily multiple micronutrient. Women with undernutrition, identified with mid-upper arm circumference <23 cm, will receive a daily fortified balanced energy protein supplement. Placebo tablets will be administered twice in pregnancy: at enrollment (<=24 weeks) and a follow up ANC visit at least 4 weeks later.

Treatment:

Drug: Placebo oral tablet 500 mg

Dietary Supplement: Multiple Micronutrient or Fortified Balanced Energy Protein Supplement

ENP: Azithromycin

Experimental group

Description:

Pregnant women will receive a daily multiple micronutrient. Women with undernutrition, identified with mid-upper arm circumference <23 cm, will receive a daily fortified balanced energy protein supplement. Azithromycin will be provided twice in pregnancy: at enrollment (<=24 weeks) and a follow up ANC visit at least 4 weeks later.

Treatment:

Drug: Azithromycin 500 mg

Dietary Supplement: Multiple Micronutrient or Fortified Balanced Energy Protein Supplement

ENP: EIMP

Experimental group

Description:

Pregnant women will receive a daily multiple micronutrient. Women with undernutrition, identified with mid-upper arm circumference <23 cm, will receive a daily fortified balanced energy protein supplement. At the study enrollment visit, pregnant women will receive presumptive deworming (albendazole) and screening for urinary tract infection and sexually transmitted infections (chlamydia and gonorrohea). Women with identified infections will be treated with appropriate antibiotics. A second dose of albendazole will be given at a follow up ANC visit at least 4 weeks after enrollment.

Treatment:

Other: Enhanced Infection Management Package (EIMP)

Dietary Supplement: Multiple Micronutrient or Fortified Balanced Energy Protein Supplement