Using antibiotics to reduce complications in obese pregnant women during labor induction
Antibiotic Prophylaxis to Prevent Obesity-Related Induction Complications in Nulliparae at Term 2.0 (APPOINT 2.0): A Multi-center Randomized Controlled Trial
PHASE2 · University of Oklahoma · NCT06488781
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 | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 787 (estimated) |
| Ages | 15 Years to 45 Years |
| Sex | Female |
| Sponsor | University of Oklahoma (other) |
| Locations | 1 site (Oklahoma City, Oklahoma) |
| Trial ID | NCT06488781 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Previous pilot studies have shown success with similar approaches, indicating the potential effectiveness of prophylactic antibiotics in this population.
Eligibility criteria
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 this trial is running
Oklahoma City, Oklahoma
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Obesity in Pregnancy, Labor Complication