At a glance
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Antibiotic Prophylaxis to Prevent Obesity-Related Induction Complications in Nulliparae at Term (APPOINT): A Pilot Randomized Controlled Trial
In Brief
A Early Phase 1 clinical trial evaluating Cefazolin, Placebo, and 1 other intervention for Obesity and Induction of Labor Affected Fetus / Newborn. Completed, enrolled 186 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
intravenous drugs used as prophylactic antibiotics
Intravenous saline
prophylactic antibiotic