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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
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
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
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
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.
Birth weight
Mean infant weight (g) among live born infants measured \<72 hour of delivery
Time frame: Within 72 hours of birth
Birth length
Mean infant length (cm) among live born infants measured \<72 hours of delivery
Time frame: Within 72 hours of birth
Gestational age
Mean gestational age at delivery
Time frame: Birth
Preterm birth
Proportion of pregnancies resulting in spontaneous birth \<37 weeks gestation among all births
Time frame: Birth
Small-for-gestational age (SGA)
Proportions of newborns born SGA (\<10% birthweight for gestational age and sex) among live born infants whose birthweight if measured within 72 hours of delivery.
Time frame: within 72 hours of birth
Low birthweight
Proportion of newborns born with weight \<2500 g among liveborn infants whose weight is measured within 72 hours of delivery
Time frame: within 72 hours of birth
Length-for-age
Mean Length-for-age Z scores at birth and 6 months of age among live born infants based on the WHO growth reference standards (WHO 2006)
Time frame: Birth, 6 months
Weight-for-age
Mean Weight-for-age Z scores at birth and 6 months of age among live born infants based on the WHO growth reference standards (WHO 2006)
Time frame: Birth, 6 months
Rate of weight gain in pregnancy
Maternal weight gain (kg) per week gestation in the 2nd and 3rd trimester
Time frame: 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
Mean hemoglobin concentration
Time frame: Third trimester antenatal care visit (28-40 weeks gestation)
Stillbirth
Rate of stillbirths per 1000 births
Time frame: Birth
Prevalence of nasopharyngeal macrolide resistance in mothers-infants
Prevalence of nasopharyngeal macrolide resistance among S. pneumoniae isolates in mothers-infants at 1 and 6 months postpartum
Time frame: 1 and 6 months post-partum
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