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

Preterm Birth Clinical Trial

— ENAT  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04171388
• Other study ID #: 2018P002479
• Status: Withdrawn
• Phase: Phase 4
• Start date: March 1, 2020
• Est. completion date: November 30, 2021

Study information

• Verified date: August 2020
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 30, 2021
• Est. primary completion date: May 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (8)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Addis Continental Institute of Public Health, Amhara Public Health Institute, Beth Israel Deaconess Medical Center, Boston Children's Hospital, Harvard School of Public Health, Jhpiego, Johns Hopkins Bloomberg School of Public Health

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Birth weight	Mean infant weight (g) among live born infants measured <72 hour of delivery	Within 72 hours of birth
Primary	Birth length	Mean infant length (cm) among live born infants measured <72 hours of delivery	Within 72 hours of birth
Secondary	Gestational age	Mean gestational age at delivery	Birth
Secondary	Preterm birth	Proportion of pregnancies resulting in spontaneous birth <37 weeks gestation among all births	Birth
Secondary	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.	within 72 hours of birth
Secondary	Low birthweight	Proportion of newborns born with weight <2500 g among liveborn infants whose weight is measured within 72 hours of delivery	within 72 hours of birth
Secondary	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)	Birth, 6 months
Secondary	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)	Birth, 6 months
Secondary	Rate of weight gain in pregnancy	Maternal weight gain (kg) per week gestation in the 2nd and 3rd trimester	From date of first 2nd trimester antenatal care (ANC) visit until date of last ANC visit before birth, assessed up to 6 months
Secondary	Maternal anemia	Mean hemoglobin concentration	Third trimester antenatal care visit (28-40 weeks gestation)
Secondary	Stillbirth	Rate of stillbirths per 1000 births	Birth
Secondary	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	1 and 6 months post-partum