Actively Recruiting
Antibiotic Prophylaxis to Prevent Obesity-Related Induction Complications in Nulliparae at Term 2.0 A Multi-center Randomized Controlled Trial
Led by University of Oklahoma · Updated on 2026-03-12
787
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Oklahoma
Lead Sponsor
U
University of Alabama at Birmingham
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether giving preventive antibiotics during labor induction can reduce the rate of cesarean delivery in first-time pregnant women with obesity. Obesity raises the risk of pregnancy complications, including infections after birth and cesarean delivery, and women with class III obesity often require delivery by 39 weeks. A prior pilot study suggested that prophylactic antibiotics might lower cesarean rates, and this larger multi-center trial aims to confirm those findings in a well-powered sample. Participants will be randomly assigned to receive either prophylactic antibiotics (azithromycin 500 mg intravenously once and cefazolin 2 grams intravenously every 8 hours for up to three doses) or matching placebos during labor induction. Both participants and their healthcare providers will be blinded to the treatment. The study will enroll 787 nulliparous women with obesity undergoing labor induction at term across six sites, following an identical protocol. During the study, trained staff will obtain consent, collect biospecimens, demographic information, and data on pregnancy and newborn outcomes. Researchers will monitor outcomes including the rate of cesarean delivery, infections such as chorioamnionitis and endometritis, postpartum hemorrhage, blood transfusions, and neonatal health measures up to 30 days after delivery. The study will assess safety and effectiveness of the antibiotic regimen compared to placebo in this population.
CONDITIONS
Brief Title
Antibiotic Prophylaxis to Prevent Obesity-Related Induction Complications in Nulliparae at Term 2.0
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Body mass index (BMI) of 30 or higher
- No prior deliveries at or beyond 20 weeks gestation
- Undergoing induction of labor
- Gestational age of 37 weeks or more
- Age between 15 and 45 years
- Not receiving intrapartum antibiotic prophylaxis for Group B Streptococcus
You will not qualify if you...
- Fetal death before labor induction
- Known fetal anomaly
- Multiple pregnancy
- Ruptured membranes for more than 12 hours
- Chorioamnionitis or other infection requiring antibiotics at labor start
- Previous myometrial surgery
- Allergy to azithromycin or beta-lactam antibiotics
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 - Up to approximately 24 hours during labor induction
Participants receive either prophylactic antibiotics or placebo intravenously during labor induction to prevent complications.
1 treatment visit during labor induction
Duration - 30 days postpartum
Participants are monitored for health outcomes and complications after delivery.
Follow-up visits as needed within 30 days postpartum
Trial Site Locations
Total: 1 location
1
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
Research Team
S
Stephanie Pierce, MD
C
Christy Zornes, MHR
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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