Status:
COMPLETED
Antibiotic Prophylaxis to Prevent Obesity-Related Induction Complications in Nulliparae at Term
Lead Sponsor:
University of Oklahoma
Conditions:
Obesity
Induction of Labor Affected Fetus / Newborn
Eligibility:
FEMALE
15-45 years
Phase:
EARLY_PHASE1
Brief Summary
Obesity increases the risk of pregnancy complications, including among others puerperal infections and cesarean delivery, and risk rises with increasing body mass index (BMI). Class III obesity is an ...
Detailed Description
Investigators will enroll consenting women delivering at The Children's Hospital at OU Medical Center who meet enrollment criteria. Flyers will be distributed to providers to give to women who may be ...
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
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 either drug used in the protocol (cefazolin or azithromycin)
Key Trial Info
Start Date :
December 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2021
Estimated Enrollment :
186 Patients enrolled
Trial Details
Trial ID
NCT03801252
Start Date
December 12 2018
End Date
June 1 2021
Last Update
April 19 2024
Active Locations (1)
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1
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104