Using antibiotics to reduce complications in obese pregnant women during labor induction
Official title: Antibiotic Prophylaxis to Prevent Obesity-Related Induction Complications in Nulliparae at Term 2.0 (APPOINT 2.0): A Multi-center Randomized Controlled Trial
Run by University of Oklahoma · NCT06488781 · Data updated 2026-11-12
This study is testing if giving antibiotics to obese pregnant women during labor induction can help lower the chances of needing a cesarean delivery and reduce infections after childbirth.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 15 Years to 45 Years |
| Sex | Women only |
| Enrollment | 787 (estimated) |
| Sponsor | University of Oklahoma Academic / other |
| Locations | 1 site (Oklahoma City, Oklahoma) |
| Status | Recruiting |
| Started | April 29, 2025 |
| Main results expected | December 2028 |
| Study ends | December 2028 |
| Registry record updated | March 12, 2026 |
| Trial ID | NCT06488781 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are nulliparous women with a BMI of 30 or greater who are undergoing induction of labor at term.
✕Probably not a fit
Patients who may not benefit from this study include those with multiple gestations, known fetal anomalies, or those requiring antibiotics for other infections at the start of labor induction.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multi-center randomized placebo-controlled trial aims to evaluate the effectiveness of prophylactic antibiotics in reducing cesarean delivery rates and puerperal infections in nulliparous women with obesity undergoing labor induction at term. A total of 787 participants will be recruited and randomly assigned to receive either a regimen of antibiotics or a placebo during labor induction. The study will be conducted across five sites, with participants and their healthcare providers blinded to the treatment assignment. Data on pregnancy and neonatal outcomes will be collected for analysis.
Why it matters
Potential benefit: If successful, this approach could significantly lower the rates of cesarean deliveries and infections in obese pregnant women, improving maternal and neonatal health outcomes.
How similar studies have gone: Previous pilot studies have shown success with similar approaches, indicating the potential effectiveness of prophylactic antibiotics in this population.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where it's running
-
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States Recruiting
Study contacts
- Principal investigator: Stephanie Pierce, MD — University of Oklahoma
- Study coordinator: Stephanie Pierce, MD
- Email: stephanie-pierce@ouhsc.edu
- Phone: 405-271-8787
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.