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Azithromycin for Cerclage Prophylaxis

This study is looking at whether giving azithromycin (an antibiotic) before a cerclage (a stitch to help keep the cervix closed during pregnancy) can help pregnant women carry their babies longer. You might be able to join if you are pregnant with one baby, are between 16 and 23 weeks pregnant, and need a transvaginal cerclage. You cannot have an active infection or certain other conditions. All participants will also receive standard care, including cefazolin (another antibiotic) and progesterone (a hormone). The researchers will compare how long women carry their pregnancies after receiving azithromycin versus a placebo (an inactive substance like normal saline). The study status is currently unclear.

Study design
This is a randomized study with two groups, aiming to enroll about 80 participants. One group will receive azithromycin prophylaxis, and the other will receive a placebo.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Researchers will follow participants to measure the time from cerclage to delivery and the gestational age at delivery, up to 42 weeks of pregnancy.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07608562

Azithromycin for Cerclage Prophylaxis

Not Yet Recruiting
PHASE4Ages 18+InterventionalTreatment
Wake Forest University Health Sciences
~80 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:Azithromycin ProphylaxisAzithromycin PlaceboCefazolinProgesterone

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Latency from Cerclage to Delivery
Measured over Up to Week 42
+1 more outcome measured

Conditions

Cervical Insufficiency

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Cervix softIncompetent Cervix

Where it's being run

2 sites across 1 states
Illinois2

Study leadership

  • Rachel Harrison, MD · PRINCIPAL_INVESTIGATOR · advocate christ medical center

Who to contact

Rachel Harrison, MD
[email protected]
616-218-2892
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Singleton gestation at 16+0 to 23+6 weeks of gestational age at the time of enrollment
Indication for transvaginal cerclage placement
Intact amniotic membranes

Exclusion

Evidence of active infection or chorioamnionitis at presentation
Preterm prelabor rupture of membranes (PPROM)
Multiple gestation
HIV positive status
Known severe allergy or contraindication to macrolide antibiotics (azithromycin or erythromycin)
Use of systemic antibiotics within the past 7 days (to avoid altered baseline vaginal microbiome)
Major fetal anomaly or known chromosomal abnormalities that significantly affect viability
Any maternal condition that would ethically preclude expectant management of pregnancy irrespective of cerclage

What this trial measures

  • Latency from Cerclage to DeliveryUp to Week 42

    Number of days from cerclage to delivery

  • Gestational Age at DeliveryUp to Week 42

    Gestational age at delivery measured in weeks and days