About this trial
Obesity increases the risk of pregnancy complications, including puerperal infections and cesarean delivery, and risk rises with increasing body mass index (BMI). Since obese women are more likely to have comorbidities that would necessitate delivery prior to their due date (i.e. prior to 40 weeks gestation), and class III obesity specifically is an indication for delivery by 39 weeks, 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 maternal morbidity and a lower cesarean rate. Researchers previously conducted a pilot randomized placebo-controlled trial in obese, nulliparous women undergoing labor induction at term and found that the cesarean delivery rate was lower in women who received a prophylactic antibiotic regimen during labor compared with those who received the placebo. Researchers proposed multi-center trial aims to test this hypothesis in a large sample with adequate power to determine whether prophylactic antibiotics during labor are associated with a decrease in the rate of cesarean delivery in term, nulliparous, obese women. If the findings from the pilot trial are confirmed, this would represent a novel intervention to decrease the cesarean delivery rate in a subset of women at highest risk for cesarean-related complications.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
BMI ≥30
No prior deliveries at or beyond 20 weeks gestation
Undergoing induction of labor
Gestational age 37 weeks or more
Disqualifiers
Fetal death prior to labor induction
Known fetal anomaly
Multiple gestation
Ruptured membranes for more than 12 hours
Trial design
Parallel
Treatments tested in this trial
Azithromycin
DrugAzithromycin 500 milligrams intravenously once and cefazolin 2 grams intravenously every 8 hours for up to three doses
Placebo
DrugPlacebo given in place of other two active drugs
Treatment groups
Trial outcomes
Primary outcomes
Rate of cesarean delivery
Determine whether a prophylactic antibiotic regimen during labor induction will decrease the rate of cesarean delivery in obese, nulliparous women undergoing induction of labor
Secondary outcomes
Rate of chorioamnionitis development
Defined clinically by fever and maternal and fetal signs such as tachycardia and uterine tenderness
Rate of endometritis
Maternal development of endometritis
Rate of cesarean wound infection
Rate of maternal would infection from cesarean section
Rate of postpartum hemorrhage
Rate of maternal postpartum hemorrhage
Sponsors and contacts
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University of Oklahoma
Lead sponsor
University of Alabama at Birmingham
Collaborator
University of Florida
Collaborator
Duke University
Collaborator
Case Western Reserve University
Collaborator
University of Utah
Collaborator