A Phase 4 interventional study of Azithromycin to pregnant women and Azithromycin to infants in Stillbirths and Infant Mortality, sponsored by University of Maryland, Baltimore. Active, not recruiting at 1 site in Mali. Per ClinicalTrials.gov, last updated 2026-08-07.
Sponsored by University of Maryland, Baltimore · Phase 4, Interventional, and Prevention
The double blind randomized controlled trial will assess the efficacy of oral azithromycin administered to pregnant women and/or infants during routine care in preventing stillbirths and mortality through 6-12 months of age in Mali, West Africa, where rates of infant and under five mortality are among the highest in the world.
This trial will assess the efficacy of oral azithromycin given during routine health care visits in preventing stillbirths and mortality through 6-12 months of age in Mali, West Africa, where rates of infant and under five mortality are among the highest in the world. Using an individually randomized placebo-controlled double-masked trial design, pregnant women will receive a single dose of oral azithromycin or placebo at their second and/or third trimester antenatal care visits and during labor, and to infants at their DPT-1 and DPT-3 vaccination visits, which occur at approximately 6 and 14 weeks of age, respectively. The two co-primary outcomes are (1A) a composite outcome of stillbirths and mortality through 6-12 months of age and (1B) mortality between 6 weeks and 6-12 months of age. The study sample size is powered to detect a 20% relative reduction in both of the two co-primary outcomes. The study is designed to inform policymakers regarding the effectiveness of azithromycin for the prevention of stillbirth and infant mortality in both urban and rural parts of the country when administered during routine antenatal and intrapartum care and infant immunization visits. To achieve this aim, three cohorts will be enrolled: a mother-infant cohort in a rural part of the country with infant mortality rates that are higher than the national average, a supplemental infant-only cohort enrolled form the same rural communities, and third urban mother-infant cohort residing in Bamako, Mali's capital. Sub studies designed to elucidate the protective mechanisms of azithromycin treatment will be embedded within the larger study and will be added in the future.
121 studies on the registry are indexed under Stillbirth; 34 are open to participants now.
This study's enrollment of 99,700 is above the median of 476 across 65 interventional studies indexed under Stillbirth.
Browse Stillbirth studies →University of Maryland, Baltimore is the lead sponsor of 700 studies on the registry; 132 are open to participants now.
Of its 92 completed or terminated interventional studies of FDA-regulated products, 66 (72%) have results posted.
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Pregnant women:
Infants:
Enrollment of pregnant women and their unborn infants will happen simultaneously. Infants attending routine immunization visits at eligible health facilities whose mothers were not enrolled in the study will be eligible for enrollment in the supplemental infant cohort within the rural study cohort with the following inclusion criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
2 gram oral dose of Azithromycin to pregnant women at their 2nd and 3rd trimester antenatal care visits and during delivery, plus 20 mg/kg to 1 gram oral dose of azithromycin to infants at 6 and 14 week Expanded Programme on Immunization (EPI) visits
Drug: Azithromycin to pregnant women · Drug: Azithromycin to infants
2 gram oral dose of Azithromycin to pregnant women at their 2nd and 3rd trimester antenatal care visits and during delivery, plus oral placebo to infants at 6 and 14 week EPI visits
Drug: Azithromycin to pregnant women · Other: Placebo to infants
Oral placebo to pregnant women at their 2nd and 3rd trimester antenatal care visits and during delivery, plus 20 mg/kg to 1 gram oral dose of azithromycin to infants at 6 and 14 week EPI visits
Drug: Azithromycin to infants · Other: Placebo to pregnant women
Placebo to pregnant women at their 2nd and 3rd trimester antenatal care visits and during delivery, plus oral placebo to infants at 6 and 14 week EPI visits
Other: Placebo to pregnant women · Other: Placebo to infants
No intervention to pregnant women and 20 mg/kg to 1 gram oral dose of azithromycin to infants at 6 and 14 week EPI visits
Drug: Azithromycin to infants · Other: No intervention to pregnant women
No intervention to pregnant women and placebo to infants at 6 and 14 week EPI visits
Other: Placebo to infants · Other: No intervention to pregnant women
Azithromycin to pregnant women at antenatal care visits and during delivery
Azithromycin to infants at 6 and 14 week EPI visits
Placebo to pregnant women at antenatal care visits and during delivery
Placebo to infants at 6 and 14 week EPI visits
No intervention to pregnant women
Rate of stillbirths and infant mortality through 6-12 months of age
Delivery outcomes assessed at intrapartum study visit and infant vital status assessed at 6 and 12 month study visits.
Time frame: 6 to 12 months
Rate of infant mortality between 6 weeks and 12 months of age
Infant vital status will be assessed at 6 and 12 month study visits.
Time frame: 6 weeks to 12 months
Gestational age at birth
Gestational age will be estimated at enrollment and at delivery.
Time frame: 3-6 months
Birth weight
Birth weight will be measured.
Time frame: 3-6 months
The incremental cost-effectiveness ratio of adding azithromycin to standard of care in Mali
Costs associated with the delivery of azithromycin will be measured and the cost-effectiveness ratio will be estimated using efficacy data from the trial.
Time frame: 6 to 18 months
Ran from Sep 2020 to primary completion in Mar 2025, 53 months.
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This study is active, not recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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University of Maryland, Baltimore →