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
Menzies School of Health Research
1,548 participants
Feb 14, 2024
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
Inclusion Criteria4
- Age greater than or equal to 16 years of age
- Pregnant Northern Territory Aboriginal and / or Torres Strait Islander women
- Pregnant non-Indigenous women who have an operative or preterm birth (27-36 weeks)
- Birthing at Royal Darwin Hospital
Exclusion Criteria9
- Previously randomised
- Azithromycin treatment within the last 7 days
- Lack of access to a primary health provider in the NT
- Allergy or hypersensitivity to azithromycin
- Not able to provide informed consent
- Gestation <26 weeks
- Not available for assessment at 6 weeks
- Women whose primary clinician intends to treat with azithromycin
- A diagnosis of chorioamnionitis or intrapartum sepsis prior to randomisation with broad spectrum antibiotics planned for >48-72hrs
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Interventions
A single 2g dose of oral azithromycin in the 24 hours prior to birth
Locations(1)
View Full Details on ANZCTR
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ACTRN12624000247572