RecruitingEarly Phase 1ACTRN12624000960550

ASAPP Pilot Trial: Efficacy of Azithromycin for Short cervix and Amniotic fluid sludge for the Prevention of Preterm birth

ASAPP: Efficacy of Azithromycin for Short cervix and Amniotic fluid sludge for the Prevention of Preterm birth, a pilot randomised controlled trial

Sponsor

The University of Melbourne

Enrollment

86 participants

Start Date

Nov 20, 2025

Study Type

Interventional

Conditions

Intra-amniotic Infection Amniotic fluid sludge Pregnancy Short Cervical Length Vaginal dysbiosis

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.

Eligibility

Sex: FemalesMin Age: 18 Yearss

Inclusion Criteria1

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 Criteria1

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.

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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.

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.