Clinical trial NCT04171388: Enhancing Nutrition and Antenatal Infection Treatment for Maternal and Child Health in Ethiopia
Official title: Enhancing Nutrition and Antenatal Infection Treatment for Maternal and Child Health in Amhara Region, Ethiopia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Low Birthweight
Preterm Birth
Maternal; Malnutrition, Affecting Fetus
Sexually Transmitted Diseases
Urinary Tract Infections
Pregnancy and Infectious Disease
Keywords: Low birthweight
Preterm birth
Maternal nutrition
Small for gestational age
Chlamydia
Gonorrhea
Urinary tract infection
Presumptive antibiotics
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Addis Continental Institute of Public Health
name: Johns Hopkins Bloomberg School of Public Health
name: Boston Children's Hospital
name: Beth Israel Deaconess Medical Center
name: Harvard School of Public Health (HSPH)
name: Amhara Public Health Institute
name: Jhpiego
First posted: 2019-11-20
Enrollment: 0
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 2x3 factorial randomized controlled trial, with cluster randomization of nutrition interventions and individually randomized infection management interventions
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Birth weight
timeFrame: Within 72 hours of birth
measure: Birth length
timeFrame: Within 72 hours of birth
Secondary outcomes:
measure: Gestational age
timeFrame: Birth
measure: Preterm birth
timeFrame: Birth
measure: Small-for-gestational age (SGA)
timeFrame: within 72 hours of birth
measure: Low birthweight
timeFrame: within 72 hours of birth
measure: Length-for-age
timeFrame: Birth, 6 months
measure: Weight-for-age
timeFrame: Birth, 6 months
measure: Rate of weight gain in pregnancy
timeFrame: From date of first 2nd trimester antenatal care (ANC) visit until date of last ANC visit before birth, assessed up to 6 months
measure: Maternal anemia
timeFrame: Third trimester antenatal care visit (28-40 weeks gestation)
measure: Stillbirth
timeFrame: Birth
measure: Prevalence of nasopharyngeal macrolide resistance in mothers-infants
timeFrame: 1 and 6 months post-partum
Other outcomes:
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