Actively Recruiting
Antibiotic Prophylaxis to Prevent Obesity-Related Induction Complications in Nulliparae at Term 2.0
Led by University of Oklahoma · Updated on 2026-03-12
787
Participants Needed
1
Research Sites
187 weeks
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
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 have comorbidities that would necessitate delivery prior to their due date (i.e. prior to 40 weeks gestation), and class III obesity specifically is an indication for delivery by 39 weeks, these patients have a high rate of labor induction. In nulliparous women from the general population (obese and non-obese), labor induction at 39 weeks (compared to expectant management) is associated with less maternal morbidity and a lower cesarean rate. Researchers previously conducted a pilot randomized placebo-controlled trial in obese, nulliparous women undergoing labor induction at term and found that the cesarean delivery rate was lower in women who received a prophylactic antibiotic regimen during labor compared with those who received the placebo. Researchers proposed multi-center trial aims to test this hypothesis in a large sample with adequate power to determine whether prophylactic antibiotics during labor are associated with a decrease in the rate of cesarean delivery in term, nulliparous, obese women. If the findings from the pilot trial are confirmed, this would represent a novel intervention to decrease the cesarean delivery rate in a subset of women at highest risk for cesarean-related complications.
CONDITIONS
Official 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...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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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
CONTACT
C
Christy Zornes, MHR
CONTACT
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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