Recruiting

Phase 3

AzithromycinAzithromycin Prophylaxis for PRElabor CEsarean DElivery Trial

Sponsor:

The George Washington University Biostatistics Center

Code:

NCT06605118

Conditions

Obstetrical Complications

Labor and Delivery Complication

Cesarean Delivery

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Accepted

Interventions

Azithromycin Injection

Placebo

Standard of Care Preoperative antibiotics

Study Details

Brief summary:

This is a phase-III multi-center double-blind randomized controlled trial of 8,000 individuals undergoing a scheduled or prelabor cesarean delivery who are randomized to either adjunctive azithromycin prophylaxis or to placebo. Both groups also will receive standard of care preoperative antibiotics (excluding azithromycin). The primary endpoint is a maternal infection composite defined as any one of the following up to 6 weeks postpartum: endometritis, wound infection, abscess, septic thrombosis, sepsis, pneumonia, pyelonephritis and breast infection.

Conditions

Obstetrical Complications

Labor and Delivery Complication

Cesarean Delivery

Study ID

NCT06605118

Start date

Nov 6, 2024

Status verified date

Apr, 2026

Completion date

Nov 30, 2027

Anticipated

Primary completion date

Nov 30, 2027

Anticipated

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

8000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Azithromycin prophylaxis and standard of care preoperative antibiotics

500mg of intravenous azithromycin administered up to 1 hour prior to cesarean incision (or as soon as feasible after incision) and infused over one hour per FDA infusion recommendations for azithromycin. Additionally patients will received standard of care preoperative antibiotics (excluding azithromycin) prior to incision.

placebo comparator: Placebo and standard of care preoperative antibiotics

Normal saline administered up to 1 hour prior to cesarean incision (or as soon as feasible after incision) and infused over one hour in addition to standard of care preoperative antibiotics (excluding azithromycin) prior to incision.

Interventions

Azithromycin Injection

500mg azithromycin in 250 mL of normal saline

Placebo

250 mL of normal saline

Standard of Care Preoperative antibiotics

standard of care preoperative antibiotics (excluding azithromycin) prior to incision

Primary outcome measure

Maternal infection composite [ Time Frame: Delivery up to 6 weeks postpartum (a period of up to 6 weeks) ]

Central Contacts and Locations

Central contacts

Rebecca G Clifton, PhD

301-881-9260 rclifton@bsc.gwu.edu

Steven Weiner, MS

weiner@bsc.gwu.edu

Locations

University of Alabama - Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Nancy Saxon, RN

205-934-1616 nbsaxon@uabmc.edu

Principal Investigator:

Alan TN Tita, MD

Regents of the University of California San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Natalie Oman, MPH

206-718-4703 natalie.oman@ucsf.edu

Principal Investigator:

Mary Norton, MD

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Elizabeth Rangel, RN

elizabeth.rangel@northwestern.edu

Principal Investigator:

Lynn Yee, MD

Columbia University

Recruiting

New York, New York, United States, 10032

Contacts

Megan Loffredo, MD, CCRC

203-722-1058 ml4639@cumc.columbia.edu

Principal Investigator:

Noelia Zork, MD

University of North Carolina - Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Kelly Clark, RN

919-350-6117 kelly_clark@med.unc.edu

Principal Investigator:

John M Thorp, MD

Duke University

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Jennifer Ferrara, RNC MSN

919-681-6176 jennifer.ferrara@duke.edu

Principal Investigator:

Brenna L Hughes, MD MS

Case Western Reserve University

Recruiting

Cleveland, Ohio, United States, 44109

Contacts

Abigail Pierse, BS

216-778-8443 apierse@metrohealth.org

Principal Investigator:

Kelly Gibson, MD

Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Anna Bartholomew, RN, BSN

614-685-3229 anna.bartholomew@osumc.edu

Principal Investigator:

Maged Costantine, MD

Hospital of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Amee Feager, RN, BSN

636-699-3433 amee.feager@pennmedicine.upenn.edu

Principal Investigator:

Lorraine Dugoff, MD

Magee Women's Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Jeanette Boyce, RN

412-527-8118 tessje@upmc.edu

Principal Investigator:

Hyagriv Simhan, MD, MS

Brown Univeristy

Recruiting

Providence, Rhode Island, United States, 02905

Contacts

Angelica DeMartino, RN, BSN

401-274-1122 amdemartino@wihri.org

Principal Investigator:

Dwight J Rouse, MD

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

Christina Reed, RN, NP

832-826-7377 christina.reed@bcm.edu

Jia Chen, RN, CCRP

713-798-3798 jia.chen@bcm.edu

Principal Investigator:

Catherine Eppes, MD, MPH

University of Texas - Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Felecia Ortiz, RN

713-500-6467 felecia.ortiz@uth.tmc.edu

Principal Investigator:

Hector Mendez-Figueroa, MD

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84132

Contacts

Amber Sowles, RN

801-585-5499 amber.sowles@hsc.utah.edu

Principal Investigator:

Torri Metz, MD

More Information

Sponsor

The George Washington University Biostatistics Center

Last update posted

Apr 9, 2026

Last verified

Apr, 2026

Keywords

cesarean delivery
infection
maternal morbidity
antibiotics
prevention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by The George Washington University Biostatistics Center on 2026-04-09.