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

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

Plain Language Summary

Simplified for easier understanding

Preterm birth — being born too early — is a leading cause of newborn illness and death. One warning sign is a short cervix (the entrance to the uterus) combined with a finding called 'amniotic fluid sludge,' which is a cloud-like substance seen in the amniotic fluid on ultrasound that appears to be associated with infection and early labour. This pilot trial is testing whether an antibiotic called azithromycin can eliminate the sludge and potentially reduce the risk of preterm birth. The study is designed to establish whether a larger, more definitive trial is feasible and to check whether azithromycin removes amniotic fluid sludge as a measurable early outcome. If successful, this research could lead to a treatment that prevents dangerous early deliveries for women with this specific combination of risk factors. You may be eligible if you are pregnant between 13 and 24 weeks of pregnancy with a cervix length of 25 mm or less and amniotic fluid sludge seen on ultrasound, and are not having signs of labour. Women with multiple pregnancies (twins, triplets), major foetal abnormalities, a prior rupture of membranes, suspected infection of the uterus, a known allergy to azithromycin, heart conditions, or significant liver disease are not eligible. The study is run by the University of Melbourne.

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

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.


Locations(4)

Joan Kirner Women’s and Children’s Hospital - St Albans

VIC, Australia

Monash Medical Centre - Clayton campus - Clayton

VIC, Australia

The Royal Women's Hospital - Parkville

VIC, Australia

Eastern Health - Box Hill

VIC, Australia

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ACTRN12624000960550


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