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NCT Number: NCT07608562

Azithromycin for Cerclage Prophylaxis

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Advocate Christ Medical Center, Oak Lawn, Illinois, United States

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About this study

The overall objective of this prospective two-arm randomized study is to (1) randomize subjects to azithromycin surgical prophylaxis versus placebo, plus the standard of care - cefazolin, at the time of cerclage placement and evaluate the impact on preterm delivery <37 weeks, <34 weeks and <28 weeks and (2) determine the prevalence of mycoplasma species in cerclage patients. Pregnant women who are candidates for cervical cerclage will be enrolled and divided into two cohorts (approximately 40 per group): (1) Cerclage + Azithromycin prophylaxis (treatment group), and (2) Cerclage without azithromycin prophylaxis (control group). Both groups will receive otherwise usual care.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Azithromycin Prophylaxis

Drug

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

Azithromycin Placebo

Drug

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

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.

Progesterone

Drug

progesterone 200 mg nightly after cerclage placement until 36 weeks gestation

Primary outcomes

  1. Latency from Cerclage to Delivery

    Time frame: Up to Week 42

    Number of days from cerclage to delivery

  2. Gestational Age at Delivery

    Time frame: Up to Week 42

    Gestational age at delivery measured in weeks and days

Secondary outcomes

  1. Incidence of Chorioamnionitis

    Time frame: Up to Week 42

    number of participants with chorioamnionitis

  2. Incidence of Preterm Premature Birth

    Time frame: 28 weeks gestation, 34 weeks gestation, 37 weeks gestation

    Number of participants that experienced preterm premature birth

  3. Incidence of Preterm Premature Rupture of Membranes

    Time frame: up to 37 weeks gestation

    Number of participants that experienced preterm premature rupture of membranes

  4. Complications from Cerclage

    Time frame: Up to Week 42

    Number participants that experienced complications from cerclage

  5. Prevalence of Mycoplasma Infection or Colonization

    Time frame: Up to Week 42

    Number of participants with prevalence of mycoplasma infection or colonization

Other outcomes

  1. Neonate Birth Weight

    Time frame: day of delivery

    weight of neonate at birth

  2. Apgar Scores

    Time frame: 1 minute post delivery, 5 minutes post delivery

    The Apgar score is a standardized test used to rapidly assess a newborn's health immediately after birth. It is evaluated at 1 minute (to see how the baby handled delivery) and 5 minutes (to check how the baby is adapting to life outside the womb). Total score range is 0-10 with a higher score indicating newborn is adapting well to life outside the womb.

  3. Number of NICU Admissions

    Time frame: day of delivery

    number of neonates admitted to NICU after delivery

  4. Length of NICU Admission

    Time frame: up to month 12

    number of days neonates spent in NICU

  5. Neonate Survival Rate

    Time frame: up to month 12

    percent of neonate survival

  6. Composite Neonate Morbidity

    Time frame: up to month 12

    composite neonatal morbidity is a yes/no outcome that is considered yes if any of the adverse outcomes are positive

Study contacts

Contact information is provided by the study sponsor or research team.

Rachel Harrison, MD

CONTACT

[email protected]

616-218-2892

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

Evaluating Azithromycin Prophylaxis and Mycoplasma Prevalence in High-Risk Pregnancies Requiring Cerclage: A Prospective Cohort Study

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 27, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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