RecruitingPhase 3Phase 4ACTRN12624000247572

Azithromycin at birth: Single dose azithromycin shortly before birth - what is the impact on infection rates in high-risk mothers and babies? A randomised controlled trial


Sponsor

Menzies School of Health Research

Enrollment

1,548 participants

Start Date

Feb 14, 2024

Study Type

Interventional

Conditions

Summary

This trial will assess whether a single dose of azithromycin (or placebo) given shortly before birth will reduce maternal and infant infections requiring antibiotic intervention in the 6 weeks following the birth, Pregnant women will be randomised close to time of delivery, and followed up for 6 weeks. Nasopharyngeal and vaginal swabs will be collected to monitor the impact of azithromycin on colonisation and resistance. Primary outcome assessment of new infections will be done by review of clinical presentations at primary health care and hospital.


Eligibility

Sex: FemalesMin Age: 16 Yearss

Plain Language Summary

Simplified for easier understanding

Infections after childbirth — including wound infections, mastitis, and uterine infections — are a significant cause of illness in new mothers and their babies, particularly in high-risk groups. Azithromycin is an antibiotic that has been shown to reduce post-operative infections when given as a single pre-operative dose in some surgical contexts. This trial asks whether a single dose given just before birth can reduce post-birth infection rates in at-risk mothers and newborns. Pregnant women who are Aboriginal and/or Torres Strait Islander, or non-Indigenous women having early (27–36 weeks) or operative births, will be randomly assigned to receive either a single dose of azithromycin or a placebo shortly before delivery. Both mothers and babies will be followed up for 6 weeks to track infection rates and antibiotic use. You may be eligible if you are 16 or older, pregnant, giving birth at Royal Darwin Hospital, and are either Aboriginal or Torres Strait Islander, or are having a preterm or operative birth. Women who have already received azithromycin in the past 7 days, have an allergy to azithromycin, are at less than 26 weeks gestation, or have been diagnosed with chorioamnionitis are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

A single 2g dose of oral azithromycin in the 24 hours prior to birth

A single 2g dose of oral azithromycin in the 24 hours prior to birth


Locations(1)

Royal Darwin Hospital - Tiwi

NT, Australia

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ACTRN12624000247572