Antibiotic Prophylaxis to Prevent Obesity-Related Induction Complications in Nulliparae at Term 2.0
Launched by UNIVERSITY OF OKLAHOMA · Jun 28, 2024
Trial Information
Current as of July 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying whether giving antibiotics during labor can help reduce the number of cesarean deliveries in obese women who are having their first baby. Obesity can make pregnancy more complicated, and many women in this group need to be induced, or have their labor started early. The researchers want to see if providing a specific antibiotic before and during labor can lower the chances of needing a cesarean section, which is a surgery to deliver the baby.
To join this study, women must be between 15 and 45 years old, have a body mass index (BMI) of 30 or higher, and be pregnant for at least 37 weeks. They should also be having their first delivery and not have any serious health issues that would prevent participation. If eligible, participants will receive either the antibiotic or a placebo, which is a dummy treatment, during labor. This study is important because if the antibiotics prove effective, they could help many women avoid the risks associated with cesarean deliveries.
Gender
FEMALE
Eligibility 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
About University Of Oklahoma
The University of Oklahoma, a leading research institution, is dedicated to advancing healthcare through innovative clinical trials and research initiatives. With a robust network of interdisciplinary experts and state-of-the-art facilities, the university fosters an environment that promotes scientific discovery and the development of new treatments. Its commitment to patient-centered research ensures that clinical trials not only adhere to the highest ethical standards but also aim to address pressing health challenges. By collaborating with various stakeholders, including industry partners and healthcare providers, the University of Oklahoma seeks to translate research findings into tangible benefits for communities, ultimately enhancing the quality of care and improving health outcomes.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Oklahoma City, Oklahoma, United States
Patients applied
Trial Officials
Stephanie Pierce, MD
Principal Investigator
University of Oklahoma
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported