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HIPAA Compliant
ISO 27001 Certified

Actively Recruiting

Phase 2
Age: 15Years - 45Years
FEMALE
ID06488781

Preventing Cesarean Delivery in Obese First-Time Mothers Through Antibiotics During Labor Induction A Multi-Center Randomized Trial

Led by University of Oklahoma · Updated on 2026-03-12

787

Participants Needed

1

Research Sites

N/A

Total Duration

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

Research Team

S

Stephanie Pierce, MD

C

Christy Zornes, MHR

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