Antibiotic Prophylaxis to Prevent Obesity-Related Induction Complications in Nulliparae at Term

• Status: Completed
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: Female

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 indication for delivery by 39 weeks, and 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 morbidity and a lower cesarean rate. Antibiotic prophylaxis, standard before cesarean delivery, is associated with less post-cesarean infection if azithromycin is added to the standard cefazolin. In this placebo-controlled pilot trial, investigators will estimate the parameters necessary to calculate the sample size for a planned multicenter clinical trial of prophylactic antibiotics administered at the start of labor inductions of morbidly obese nulliparous women at term.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Oklahoma
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Azithromycin; Cefazolin

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

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 either drug used in the protocol (cefazolin or azithromycin)