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

NCT ID: NCT06488781

Last Updated: 2025-07-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 787 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-29
• Study Completion Date: 2028-12-31

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.

Detailed Description

This is a multi-center randomized placebo-controlled trial in which nulliparous women with obesity who are undergoing induction of labor at term and not receiving IAP for GBS will be recruited (n=787). The participants will be randomized 1:1 to receive either prophylactic antibiotics during their labor induction (azithromycin 500 milligrams intravenously once and cefazolin 2 grams intravenously every 8 hours for up to three doses) or like-appearing placebos. The participants and their obstetrical providers will be blinded to the study intervention. The study will be conducted with an identical protocol at five study sites. Trained research nurses/assistants at each study site will consent and enroll participants, collect biospecimens, and collect demographic information and data on pregnancy and neonatal outcomes, and will convey this data to the primary site for analysis.

Researchers hypothesize that the group that receives the study drug regimen of prophylactic antibiotics during induction of labor will have a lower rate of cesarean delivery than the group that receives the placebo. They also hypothesize that the group that receives the study drug regimen will have a lower rate of puerperal infection than the placebo group.

Nulliparous women with obesity who are undergoing induction of labor at term will be eligible for participation in the study. Across all sites, 787 total subjects will be recruited.

Conditions

Obesity in Pregnancy; Labor Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Prophylactic antibiotics

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

Group Type: ACTIVE_COMPARATOR

Azithromycin

Intervention Type: DRUG

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo given in place of other two active drugs

Interventions

Azithromycin

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

Intervention Type: DRUG

Placebo

Placebo given in place of other two active drugs

Intervention Type: DRUG

Other Intervention Names

Cefazolin

Eligibility Criteria

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: collaborator

Case Western Reserve University

OTHER

Sponsor Role: collaborator

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephanie Pierce, MD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Locations

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Stephanie Pierce, MD

Role: CONTACT

stephanie-pierce@ouhsc.edu

405-271-8787

Christy Zornes, MHR

Role: CONTACT

christy-zornes@ouhsc.edu

405-271-8001 ext. 48137

Facility Contacts

Christy Zornes, MHR

Role: primary

christy-zornes@ouhsc.edu

405-271-8001 ext. 48137

Kyra Woods, BA

Role: backup

kyra-woods@ouhsc.edu

405-271-8001 ext. 45750

Other Identifiers

APPOINT 2.0

Identifier Type: -

Identifier Source: org_study_id