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

This is a multi-centre pilot randomised controlled trial (RCT) to assess the efficacy of oral azithromycin in eliminating amniotic fluid sludge (AFS) as a surrogate outcome for preterm birth. The primary research question is whether treatment with oral azithromycin results in eradication of amniotic fluid sludge two weeks after randomisation in asymptomatic pregnant women with cervical length ≤25.0mm and AFS identified between 13+0-24+0 weeks’ gestation. The study objectives include 1. To determine whether azithromycin treatment in asymptomatic women at high risk for preterm birth is efficacious in eliminating AFS. 2. To determine whether azithromycin treatment prevents further shortening of cervical length. 3. To determine whether azithromycin treatment alters the vaginal flora / microbiome 4. To determine the feasibility of undertaking a larger multicentre trial to determine whether azithromycin therapy is effective in preventing neonatal morbidity associated with preterm birth. Feasibility will be determined by: i. Participant acceptance of the study (recruitment rate) ii. Clinician acceptance of the study (clinicians willing to offer the trial and randomise participants) The Trial has been registered with the Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12624000960550 and has been funded by a grant from the Victorian Medical Research Acceleration Fund (VMRAF) funded by the State Government of Victoria (Jobs, Skills, Industry and Regions) and matched funding from Western Health (Western Health Foundation and MFM research funds) to fund the Trial Coordinator and Research Assistant. This study will be recruiting participants from Monash Health and Western Health.