Active — Not RecruitingPhase 4

Oral Azithromycin to Prevent Stillbirths and Infant Mortality in Mali

Mali99,700 participantsStarted 2020-09-24

Plain-language summary

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.

Who can participate

SexALL

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Inclusion criteria

✓. Participant is attending an ANC visit between 13 and 37 weeks gestation, with gestational age estimated using fundal height measurements and/or maternal report of quickening, at a participating health facility.
✓. Participant is able to understand and comply with planned study procedures.
✓. Participant has provided informed consent prior to initiation of any study procedures.
✓. Participant intends to reside in the study area until her newborn infant is at least 12 months old.
✓. Infant is \<12 mo attending a DTP-1 routine vaccination visit at a participating health facility.
✓. Parent or guardian is able to understand and comply with planned study procedures.
✓. Parent or guardian has provided informed consent prior to initiation of any study procedures.
✓. Parent or guardian intends to reside in the study area until participant is at least 12 months old.

Exclusion criteria

✕. Allergy to macrolides or azalides.
✕. Any condition that, in the opinion of the investigator, might compromise the well-being of the participant or compliance with study procedures.
✕. Medical treatment that requires administration of azithromycin (this can be a temporary exclusion if the drug is later discontinued).

What they're measuring

Rate of stillbirths and infant mortality through 6-12 months of age

Timeframe: 6 to 12 months

Rate of infant mortality between 6 weeks and 12 months of age

Timeframe: 6 weeks to 12 months

Trial details

NCT IDNCT03909737

SponsorUniversity of Maryland, Baltimore

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-01

View on ClinicalTrials.gov More Stillbirths and Infant Mortality trials