Cervical InsufficiencyPhase 4NCT07608562
Azithromycin for Cerclage Prophylaxis
A Phase 4 study testing Azithromycin Prophylaxis, Cefazolin and Progesterone in people with Cervical Insufficiency, run by Wake Forest University Health Sciences at 2 sites in United States.
Trial summary
The primary goal is to assess the effectiveness in pregnancy prolongation utilizing azithromycin at the time of transvaginal cervical cerclage placement. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Insufficiency
- What is being tested?
- Azithromycin Prophylaxis, Cefazolin and Progesterone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2026to Dec 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453
Rachel Harrison, MD, 616-218-2892, rachel.harrison@aah.org
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068
About this study
Official title: Evaluating Azithromycin Prophylaxis and Mycoplasma Prevalence in High-Risk Pregnancies Requiring Cerclage: A Prospective Cohort Study
The primary goal is to assess the effectiveness in pregnancy prolongation utilizing azithromycin at the time of transvaginal cervical cerclage placement.
Read the detailed description
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.
- Conditions
- Cervical Insufficiency
- Being tested
- Azithromycin Prophylaxis, Azithromycin Placebo, Cefazolin, Progesterone
- Keywords
- short cervix, pregnancy prolongation, cerclage
- Medical subject headings
- Uterine Cervical Incompetence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azithromycin ProphylaxisDrug
500 mg of IV azithromycin prior to cerclage placement in the operating room or pre-operative area.
Azithromycin PlaceboDrug
normal saline placebo IV infusion prior to cerclage placement in the operating room or pre-operative area
CefazolinDrug
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.
ProgesteroneDrug
progesterone 200 mg nightly after cerclage placement until 36 weeks gestation
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Azithromycin Placebo; Drug: Cefazolin; Drug: Progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Latency from Cerclage to Delivery
Number of days from cerclage to delivery
Measured: Up to Week 42
Gestational Age at Delivery
Gestational age at delivery measured in weeks and days
Measured: Up to Week 42
Secondary outcomes (5)
Incidence of Chorioamnionitis
number of participants with chorioamnionitis
Measured: Up to Week 42
Incidence of Preterm Premature Birth
Number of participants that experienced preterm premature birth
Measured: 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
Measured: up to 37 weeks gestation
Complications from Cerclage
Number participants that experienced complications from cerclage
Measured: Up to Week 42
Prevalence of Mycoplasma Infection or Colonization
Number of participants with prevalence of mycoplasma infection or colonization
Measured: Up to Week 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study startSep 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachel Harrison, MD, Principal investigator, advocate christ medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07608562
- Sponsor's protocol ID
- IRB00131410
- Status last verified
- Aug 2026
- First submitted
- 20 May 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Azithromycin Prophylaxis and Mycoplasma Prevalence in High-Risk Pregnancies Requiring Cerclage: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07608562
- Acronym / sponsor ID
- IRB00131410
- Conditions
- Cervical Insufficiency
- Keywords
- short cervix, pregnancy prolongation, cerclage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 27 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary goal is to assess the effectiveness in pregnancy prolongation utilizing azithromycin at the time of transvaginal cervical cerclage placement.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cerclage and Azithromycin Prophylaxis | Experimental | Drug: Azithromycin Prophylaxis, Drug: Cefazolin, Drug: Progesteronewomen at high risk for mid-trimester loss or early preterm birth who choose to undergo a cerclage as part of standard care recommendations |
| Cerclage Without Azithromycin Prophylaxis | Active comparator | Drug: Azithromycin Placebo, Drug: Cefazolin, Drug: Progesteronewomen at high risk for mid-trimester loss or early preterm birth who choose to undergo a cerclage as part of standard care recommendations |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Azithromycin Prophylaxis500 mg of IV azithromycin prior to cerclage placement in the operating room or pre-operative area. | Drug | Cerclage and Azithromycin Prophylaxis |
| Azithromycin Placebonormal saline placebo IV infusion prior to cerclage placement in the operating room or pre-operative area | Drug | Cerclage Without Azithromycin Prophylaxis |
| CefazolinAll 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. | Drug | Cerclage Without Azithromycin Prophylaxis, Cerclage and Azithromycin Prophylaxis |
| Progesteroneprogesterone 200 mg nightly after cerclage placement until 36 weeks gestation | Drug | Cerclage Without Azithromycin Prophylaxis, Cerclage and Azithromycin Prophylaxis |
Primary outcome
Latency from Cerclage to Delivery
Time frame: Up to Week 42
Number of days from cerclage to delivery
Gestational Age at Delivery
Time frame: Up to Week 42
Gestational age at delivery measured in weeks and days
5 secondary outcomes
Incidence of Chorioamnionitis
Time frame: Up to Week 42
Incidence of Preterm Premature Birth
Time frame: 28 weeks gestation, 34 weeks gestation, 37 weeks gestation
Incidence of Preterm Premature Rupture of Membranes
Time frame: up to 37 weeks gestation
Complications from Cerclage
Time frame: Up to Week 42
Prevalence of Mycoplasma Infection or Colonization
Time frame: Up to Week 42
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rachel Harrison, MD principal investigator
advocate christ medical center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Azithromycin Prophylaxis, Cefazolin and Progesterone in people with Cervical Insufficiency, run by Wake Forest University Health Sciences at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel Harrison, MD (616-218-2892, rachel.harrison@aah.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Latency from Cerclage to Delivery (time frame: Up to Week 42). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.