Recruiting
Phase 2

Antibiotic Prophylaxis

Sponsor:

University of Oklahoma

Code:

NCT06488781

Conditions

Obesity in Pregnancy

Labor Complication

Eligibility Criteria

Sex: Female

Age: 15 - 45

Healthy Volunteers: Not accepted

Interventions

Azithromycin

Placebo

Study Details

Brief summary:

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.

Conditions

Obesity in Pregnancy

Labor Complication

Study ID

NCT06488781

Start date

Apr 29, 2025

Status verified date

Mar, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 15 - 45

Healthy Volunteers: Not accepted

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
  • Not receiving IAP for GBS prophylaxis

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 azithromycin or beta-lactam antibiotics

Study Design

Enrollment

787 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Prophylactic antibiotics

Azithromycin 500 milligrams intravenously once and cefazolin 2 grams intravenously every 8 hours for up to three doses

placebo comparator: Placebo

Placebos, similar in appearance, in place of azithromycin and cefazolin

Interventions

Azithromycin

Azithromycin 500 milligrams intravenously once and cefazolin 2 grams intravenously every 8 hours for up to three doses

Placebo

Placebo given in place of other two active drugs

Primary outcome measure

  • Rate of cesarean delivery [ Time Frame: 30 days postpartum ]

Central Contacts and Locations

Central contacts

Locations

University of Oklahoma Health Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Principal Investigator:

Stephanie Pierce, MD

More Information

Sponsor

University of Oklahoma

Last update posted

Mar 12, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Oklahoma on 2026-03-12.