A Phase 4 interventional study of Azithromycin Prophylaxis and Azithromycin Placebo in Cervical Insufficiency, sponsored by Wake Forest University Health Sciences. Not yet recruiting at 2 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by Wake Forest University Health Sciences · Phase 4, Interventional, and Treatment
The primary goal is to assess the effectiveness in pregnancy prolongation utilizing azithromycin at the time of transvaginal cervical cerclage placement.
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.
34 studies on the registry are indexed under Uterine Cervical Incompetence; 10 are open to participants now.
This study's planned enrollment of 80 is above the median of 60 across 23 interventional studies indexed under Uterine Cervical Incompetence.
Browse Uterine Cervical Incompetence studies →Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
500 mg of IV azithromycin prior to cerclage placement in the operating room or pre-operative area.
normal saline placebo IV infusion prior to cerclage placement in the operating room or pre-operative area
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 200 mg nightly after cerclage placement until 36 weeks gestation
Latency from Cerclage to Delivery
Number of days from cerclage to delivery
Time frame: Up to Week 42
Gestational Age at Delivery
Gestational age at delivery measured in weeks and days
Time frame: Up to Week 42
Incidence of Chorioamnionitis
number of participants with chorioamnionitis
Time frame: Up to Week 42
Incidence of Preterm Premature Birth
Number of participants that experienced preterm premature birth
Time frame: 28 weeks gestation, 34 weeks gestation, 37 weeks gestation
Incidence of Preterm Premature Rupture of Membranes
Number of participants that experienced preterm premature rupture of membranes
Time frame: up to 37 weeks gestation
Complications from Cerclage
Number participants that experienced complications from cerclage
Time frame: Up to Week 42
Prevalence of Mycoplasma Infection or Colonization
Number of participants with prevalence of mycoplasma infection or colonization
Time frame: Up to Week 42
Neonate Birth Weight
weight of neonate at birth
Time frame: day of delivery
Apgar Scores
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.
Time frame: 1 minute post delivery, 5 minutes post delivery
Number of NICU Admissions
number of neonates admitted to NICU after delivery
Time frame: day of delivery
Length of NICU Admission
number of days neonates spent in NICU
Time frame: up to month 12
Neonate Survival Rate
percent of neonate survival
Time frame: up to month 12
Composite Neonate Morbidity
composite neonatal morbidity is a yes/no outcome that is considered yes if any of the adverse outcomes are positive
Time frame: up to month 12
Plan to share: No
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This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Uterine Cervical Incompetence→
Wake Forest University Health Sciences