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

NCT06488781 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: APPOINT 2.0
• Study Type: interventional
• Target: 787
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

  30 days postpartum

Secondary Outcomes (18)

• Rate of chorioamnionitis development

  30 days postpartum

• Rate of endometritis

  30 days postpartum

• Rate of cesarean wound infection

  30 days postpartum

• Rate of postpartum hemorrhage

  30 days postpartum

• Rate of blood transfusion

  30 days postpartum

Study Arms (2)

Prophylactic antibiotics

ACTIVE COMPARATOR

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

Drug: Azithromycin

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Azithromycin DRUG

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

Also known as: Cefazolin

Prophylactic antibiotics

Placebo DRUG

Placebo given in place of other two active drugs

Placebo

Eligibility Criteria

• Age: 15 Years - 45 Years
• Gender Eligibility Details: All subjects in this study will be pregnant women and fetus/infant dyads
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oklahoma: lead
• University of Alabama at Birmingham: collaborator
• Duke University: collaborator
• University of Florida: collaborator
• Case Western Reserve University: collaborator
• University of Utah: collaborator

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

MeSH Terms

Conditions

Pregnancy in Obesity; Obstetric Labor Complications

Interventions

Azithromycin; Cefazolin

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Cephalosporins; beta-Lactams; Lactams; Amides; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Stephanie Pierce, MD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie Pierce, MD

CONTACT

405-271-8787; stephanie-pierce@ouhsc.edu

Christy Zornes, MHR

CONTACT

405-271-8001; christy-zornes@ouhsc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Study participants, clinical personnel, and members of the research team responsible for collecting clinical outcomes will be blinded to the treatment group allocation. The research pharmacist at each site and the research analyst generating the randomization scheme will be the only study team members to know the treatment group allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomly assigned 1:1 to receive either the prophylactic antibiotic regimen or placebos during labor induction.

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: July 5, 2024
• Study Start: April 29, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

US (1)