Enhancing Nutrition and Antenatal Infection Treatment for Maternal and Child Health in Amhara Region, Ethiopia
Trial Snapshot
- Phase
- Phase 4
- Status
- Withdrawn
- Sponsor
- Brigham and Women's Hospital
- Primary Endpoint
- Birth weight
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Masking of Azithro vs. Placebo arm only
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Routine care: Placebo
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.
Intervention: Placebo oral tablet 500 mg (Drug)
Routine care: Azithromycin
Azithromycin will be provided twice in pregnancy: at enrollment (<=24 weeks) and a follow up ANC visit at least 4 weeks later.
Intervention: Azithromycin 500 mg (Drug)
Routine care: Enhanced Infection Management Package (EIMP)
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.
Intervention: Enhanced Infection Management Package (EIMP) (Other)
Enhanced Nutrition Package (ENP): Placebo
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.
Intervention: Multiple Micronutrient or Fortified Balanced Energy Protein Supplement (Dietary Supplement)
Enhanced Nutrition Package (ENP): Placebo
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.
Intervention: Placebo oral tablet 500 mg (Drug)
ENP: Azithromycin
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.
Intervention: Azithromycin 500 mg (Drug)
ENP: Azithromycin
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.
Intervention: Multiple Micronutrient or Fortified Balanced Energy Protein Supplement (Dietary Supplement)
ENP: EIMP
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.
Intervention: Multiple Micronutrient or Fortified Balanced Energy Protein Supplement (Dietary Supplement)
ENP: EIMP
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.
Intervention: Enhanced Infection Management Package (EIMP) (Other)
Outcomes
Primary Outcomes
Birth weight
Time Frame: Within 72 hours of birth
Mean infant weight (g) among live born infants measured \<72 hour of delivery
Birth length
Time Frame: Within 72 hours of birth
Mean infant length (cm) among live born infants measured \<72 hours of delivery
Secondary Outcomes
- Gestational age(Birth)
- Preterm birth(Birth)
- Small-for-gestational age (SGA)(within 72 hours of birth)
- Low birthweight(within 72 hours of birth)
- Length-for-age(Birth, 6 months)
- Weight-for-age(Birth, 6 months)
- Rate of weight gain in pregnancy(From date of first 2nd trimester antenatal care (ANC) visit until date of last ANC visit before birth, assessed up to 6 months)
- Maternal anemia(Third trimester antenatal care visit (28-40 weeks gestation))
- Stillbirth(Birth)
- Prevalence of nasopharyngeal macrolide resistance in mothers-infants(1 and 6 months post-partum)
Investigators
Anne Lee
Pediatric Hospitalist, Director of Global Newborn Health, Department of Pediatric Newborn Medicine
Brigham and Women's Hospital