drugset / Trial / NCT03801252

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

NCT03801252

Phase 0 Completed 186 enrolled University of Oklahoma
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2018-12-12
Primary completion
2021-06-01
Completion
2021-06-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Azithromycin Small molecule 500 mg Intravenous
Subject Cefazolin Small molecule 2 g Intravenous

Indications