Status:
RECRUITING
Antibiotic Prophylaxis to Prevent Obesity-Related Induction Complications in Nulliparae at Term 2.0
Lead Sponsor:
University of Oklahoma
Collaborating Sponsors:
University of Alabama at Birmingham
University of Florida
Conditions:
Obesity in Pregnancy
Labor Complication
Eligibility:
FEMALE
15-45 years
Phase:
PHASE2
Brief Summary
Obesity increases the risk of pregnancy complications, including puerperal infections and cesarean delivery, and risk rises with increasing body mass index (BMI). Since obese women are more likely to ...
Detailed Description
This is a multi-center randomized placebo-controlled trial in which nulliparous women with obesity who are undergoing induction of labor at term and not receiving IAP for GBS will be recruited (n=787)...
Eligibility Criteria
Inclusion
- BMI ≥30
- No prior deliveries at or beyond 20 weeks gestation
- Undergoing induction of labor
- Gestational age 37 weeks or more
- Age 15-45
- Not receiving IAP for GBS prophylaxis
Exclusion
- Fetal death prior to labor induction
- Known fetal anomaly
- Multiple gestation
- Ruptured membranes for more than 12 hours
- Chorioamnionitis or other infection requiring antibiotics at the start of the labor induction
- Previous myometrial surgery
- Allergy to azithromycin or beta-lactam antibiotics
Key Trial Info
Start Date :
April 29 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
787 Patients enrolled
Trial Details
Trial ID
NCT06488781
Start Date
April 29 2025
End Date
December 1 2028
Last Update
July 17 2025
Active Locations (1)
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1
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104