Actively Recruiting

Phase 2
Age: 15Years - 45Years
FEMALE
NCT06488781

Antibiotic Prophylaxis to Prevent Obesity-Related Induction Complications in Nulliparae at Term 2.0

Led by University of Oklahoma · Updated on 2026-03-12

787

Participants Needed

1

Research Sites

187 weeks

Total Duration

On this page

Sponsors

U

University of Oklahoma

Lead Sponsor

U

University of Alabama at Birmingham

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Antibiotic Prophylaxis to Prevent Obesity-Related Induction Complications in Nulliparae at Term 2.0

Who Can Participate

Age: 15Years - 45Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States, 73104

Actively Recruiting

Loading map...

Research Team

S

Stephanie Pierce, MD

CONTACT

C

Christy Zornes, MHR

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here