New trial tests antibiotic to cut C-Section infections
NCT ID NCT06605118
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 3 trial is testing whether adding a single dose of azithromycin to standard antibiotics can prevent infections in 8,000 women having scheduled C-sections. Participants receive either azithromycin or a placebo, plus usual care. The study tracks infections like wound infections, endometritis, and sepsis up to 6 weeks after delivery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- azithromycin
- What this could lead to
- If it works, this could reduce the risk of serious infections after scheduled C-sections, making recovery safer for mothers.
- What could go wrong
- This is a large trial, but azithromycin may not lower infection rates beyond standard care, and overuse could contribute to antibiotic resistance.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 8,000 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2024
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * ≥ 23 weeks' gestation (ACOG dating criteria) * Scheduled or prelabor cesarean delivery * Singleton or twin gestation Exclusion Criteria: * Allergy or contraindication to azithromycin or macrolide antibiotics, including those with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin * Chorioamnionitis * Bacterial infection (e.g., pyelonephritis) requiring ongoing antibiotic treatment after delivery * Premature rupture of membranes (PROM) or labor (i.e., contractions with ongoing cervical change) * Fetal demise or known major congenital anomaly * Azithromycin treatment within 7 days * Planned use of antimicrobial prophylaxis after delivery for any reason * Known structural heart disease or active cardiomyopathy (current ejection fraction\<40%) * Known arrhythmia with QT prolongation or taking scheduled medications known to prolong the QT interval such that it would preclude the use of azithromycin * Refusal or unable to obtain consent (e.g., language barrier) * Participating in another intervention study that influences the primary outcome in this study * Participation in this trial in a previous pregnancy. Patients who were screened in a previous pregnancy, but not randomized, do not have to be excluded.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
14 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Baylor College of Medicine
RECRUITINGHouston, Texas, 77030, United States
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Brown Univeristy
RECRUITINGProvidence, Rhode Island, 02905, United States
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Case Western Reserve University
RECRUITINGCleveland, Ohio, 44109, United States
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Columbia University
RECRUITINGNew York, New York, 10032, United States
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Duke University
RECRUITINGDurham, North Carolina, 27710, United States
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Hospital of the University of Pennsylvania
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
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Magee Women's Hospital
RECRUITINGPittsburgh, Pennsylvania, 15213, United States
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Northwestern University
RECRUITINGChicago, Illinois, 60611, United States
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Ohio State University
RECRUITINGColumbus, Ohio, 43210, United States
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Regents of the University of California San Francisco
RECRUITINGSan Francisco, California, 94143, United States
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University of Alabama - Birmingham
RECRUITINGBirmingham, Alabama, 35233, United States
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University of North Carolina - Chapel Hill
RECRUITINGChapel Hill, North Carolina, 27599, United States
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University of Texas - Houston
RECRUITINGHouston, Texas, 77030, United States
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University of Utah
RECRUITINGSalt Lake City, Utah, 84132, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a new pain drug match morphine for C-Section recovery?
- Could a simple wrist grip ease anxiety during C-Section?
- Can tighter blood pressure control in pregnancy prevent serious complications?
- Could a scent and a touch soothe Post-Surgery pain?
- Finger sensor may read pain and anxiety during c-section
- Eye reflex may flag hidden risk in cesarean births