Actively Recruiting
Azithromycin Prophylaxis for Prelabor Cesarean Delivery Trial
Led by The George Washington University Biostatistics Center · Updated on 2026-04-09
8000
Participants Needed
14
Research Sites
N/A
Total Duration
On this page
Sponsors
T
The George Washington University Biostatistics Center
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying whether adding azithromycin to the usual antibiotics given before a scheduled or prelabor cesarean delivery can reduce infections after surgery. This phase III trial involves 8,000 individuals and compares azithromycin with a placebo while all participants receive standard antibiotics. The main goal is to see if azithromycin lowers the risk of infections such as wound infections, sepsis, pneumonia, and breast infections up to six weeks after delivery. Participants are randomly assigned to receive either 500mg of intravenous azithromycin or a placebo (normal saline) about one hour before the cesarean incision. Both groups also get the standard antibiotic treatment before surgery, excluding azithromycin. Blood samples from the mother and baby may be collected in some cases. Researchers will track health outcomes related to infections and other complications during delivery and hospital stay. Participants will have one follow-up visit between 4 and 8 weeks after giving birth to assess both maternal and newborn health. During the study, medical records will be reviewed to monitor outcomes. The trial will measure infection rates, wound complications, hospital stay length, neonatal intensive care admissions, use of healthcare resources, and presence of antibiotic-resistant infections. The total study period for each participant lasts up to six weeks postpartum.
CONDITIONS
Brief Title
Azithromycin Prophylaxis for PRElabor CEsarean DElivery Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 23 weeks pregnant based on ACOG dating criteria
- Scheduled or prelabor cesarean delivery
- Singleton or twin pregnancy
You will not qualify if you...
- Allergy or contraindication to azithromycin or macrolide antibiotics
- History of cholestatic jaundice or liver problems from azithromycin
- Chorioamnionitis
- Bacterial infection requiring antibiotics after delivery
- Premature rupture of membranes or labor with cervical change
- Fetal demise or major known birth defects
- Azithromycin treatment within the past 7 days
- Planned use of antibiotics after delivery
- Known heart disease with low ejection fraction or active cardiomyopathy
- Known arrhythmia with QT prolongation or on medications prolonging QT interval
- Unable to consent or refusal to participate
- Participation in another study affecting this trial's outcomes
- Previous participation in this trial during an earlier pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single administration on the day of cesarean delivery
Participants receive either intravenous azithromycin or placebo up to 1 hour prior to cesarean incision along with standard preoperative antibiotics.
1 visit (in-person)
Duration - Up to 6 weeks postpartum
Participants have a study visit 6 weeks postpartum to assess maternal and neonatal outcomes and safety.
1 visit (in-person) between 4 to 8 weeks postpartum
Trial Site Locations
Total: 14 locations
1
University of Alabama - Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Regents of the University of California San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
3
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
4
Columbia University
New York, New York, United States, 10032
Actively Recruiting
5
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
6
Duke University
Durham, North Carolina, United States, 27710
Actively Recruiting
7
Case Western Reserve University
Cleveland, Ohio, United States, 44109
Actively Recruiting
8
Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
9
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
10
Magee Women's Hospital
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
11
Brown Univeristy
Providence, Rhode Island, United States, 02905
Actively Recruiting
12
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
13
University of Texas - Houston
Houston, Texas, United States, 77030
Actively Recruiting
14
University of Utah
Salt Lake City, Utah, United States, 84132
Actively Recruiting
Research Team
R
Rebecca G Clifton, PhD
S
Steven Weiner, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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