Azithromycin for Cerclage Prophylaxis

NCT07608562 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: IRB00131410
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

The primary goal is to assess the effectiveness in pregnancy prolongation utilizing azithromycin at the time of transvaginal cervical cerclage placement.

Conditions

Cervical Insufficiency

Keywords

short cervix; pregnancy prolongation; cerclage

Outcome Measures

Primary Outcomes (2)

• Latency from Cerclage to Delivery

  Number of days from cerclage to delivery

  Up to Week 42

• Gestational Age at Delivery

  Gestational age at delivery measured in weeks and days

  Up to Week 42

Secondary Outcomes (5)

• Incidence of Chorioamnionitis

  Up to Week 42

• Incidence of Preterm Premature Birth

  28 weeks gestation, 34 weeks gestation, 37 weeks gestation

• Incidence of Preterm Premature Rupture of Membranes

  up to 37 weeks gestation

• Complications from Cerclage

  Up to Week 42

• Prevalence of Mycoplasma Infection or Colonization

  Up to Week 42

Other Outcomes (6)

• Neonate Birth Weight

  day of delivery

• Apgar Scores

  1 minute post delivery, 5 minutes post delivery

• Number of NICU Admissions

  day of delivery

Study Arms (2)

Cerclage and Azithromycin Prophylaxis

EXPERIMENTAL

women at high risk for mid-trimester loss or early preterm birth who choose to undergo a cerclage as part of standard care recommendations

Drug: Azithromycin Prophylaxis; Drug: Cefazolin; Drug: Progesterone

Cerclage Without Azithromycin Prophylaxis

ACTIVE COMPARATOR

women at high risk for mid-trimester loss or early preterm birth who choose to undergo a cerclage as part of standard care recommendations

Drug: Azithromycin Placebo; Drug: Cefazolin; Drug: Progesterone

Interventions

Progesterone DRUG

progesterone 200 mg nightly after cerclage placement until 36 weeks gestation

Cerclage Without Azithromycin Prophylaxis; Cerclage and Azithromycin Prophylaxis

Azithromycin Prophylaxis DRUG

500 mg of IV azithromycin prior to cerclage placement in the operating room or pre-operative area.

Cerclage and Azithromycin Prophylaxis

Azithromycin Placebo DRUG

normal saline placebo IV infusion prior to cerclage placement in the operating room or pre-operative area

Cerclage Without Azithromycin Prophylaxis

Cefazolin DRUG

All participants will receive standard of care cefazolin. First dose is to be given preoperatively, and the next two doses to be given 8 and 16 hours postoperatively. Participants weighing less than 100 kg will receive 2 g cefazolin, and those weighing 100 kg or more will receive 3 g cefazolin.

Cerclage Without Azithromycin Prophylaxis; Cerclage and Azithromycin Prophylaxis

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (2)

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453, United States

Location

Advocate Lutheran General Hospital

Park Ridge, Illinois, 60068, United States

Location

MeSH Terms

Conditions

Uterine Cervical Incompetence

Interventions

Cefazolin; Progesterone

Condition Hierarchy (Ancestors)

Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Abortion, Habitual; Abortion, Spontaneous; Pregnancy Complications; Genital Diseases

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Study Officials

• Rachel Harrison, MD

  advocate christ medical center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Harrison, MD

CONTACT

616-218-2892; rachel.harrison@aah.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: May 27, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 23, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)