None listed
Conditions
Brief summary
Multi-centre pilot randomised controlled trial to assess the efficacy of oral Azithromycin in eliminating Amniotic fluid sludge as a surrogate outcome for preterm birth. We hope that the results from this study will help up develop a bigger trial which will directly assess the impact of azithromycin in reducing the risk of preterm birth.
Interventions
The intervention in this pilot study is the use of oral Azithromycin capsules (5 x 500mg). Patients randomised to receive the investigational product will take one 500mg capsule daily for five days. To monitor adherence to the intervention, participants will be asked to keep a medication diary and to bring their empty packaging or any unused capsules back to the research staff members.
Sponsors
The University of Melbourne
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Pregnant women from 13 weeks 0 days gestation to 24 weeks 0 days gestation, with cervical length less than or equal to 25.0mm, sonographic appearance of amniotic fluid sludge and absence of symptoms suggestive of labour at randomisation.
Exclusion criteria
Multiple gestation, major or lethal fetal congenital abnormality, placenta praevia/vasa praevia, PPROM, clinical signs suggestive of chorioamnionitis, indicated preterm delivery at time of randomisation, known allergy to Azithromycin, use of medications likely to prolong QT interval, history of cardiac disease, known hepatic impairment.
Outcome results
None listed