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

Phase 2

• Conditions: Preterm birth; Short Cervical Length; Intra-amniotic Infection; Amniotic fluid sludge; Pregnancy; Vaginal dysbiosis; Reproductive Health and Childbirth - Fetal medicine and complications of pregnancy; Reproductive Health and Childbirth - Complications of newborn; Reproductive Health and Childbirth - Antenatal care; Infection - Studies of infection and infectious agents

• Registration Number: ACTRN12624000960550
• Lead Sponsor: The University of Melbourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-07
• Last Update Posted: 12 August 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 84

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome for this pilot study is the presence of amniotic fluid sludge (AFS) visible on ultrasound, 2 weeks after the course of the treatment.[ Transvaginal ultrasound. Assessment of AFS will be binary (either present” or absent”). Two weeks post-randomisation.]