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

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

Interventions

DRUG

Azithromycin

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

DRUG

Placebo

Placebo given in place of other two active drugs

Sponsors & Collaborators

• University of Alabama at Birmingham

  collaborator OTHER

• University of Florida

  collaborator OTHER

• Duke University

  collaborator OTHER

• Case Western Reserve University

  collaborator OTHER

• University of Utah

  collaborator OTHER

• University of Oklahoma

  lead OTHER

Principal Investigators

• Stephanie Pierce, MD · University of Oklahoma

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

15 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-04-29

Primary Completion

2028-12-31

Completion

2028-12-31

FDA Drug

Yes

Countries

• United States

Study Locations