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

NCT03801252 | Completed Early Phase 1 Results FDA Drug

• 1 other identifier: 9939
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

Brief Summary

Obesity increases the risk of pregnancy complications, including among others puerperal infections and cesarean delivery, and risk rises with increasing body mass index (BMI). Class III obesity is an indication for delivery by 39 weeks, and 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 morbidity and a lower cesarean rate. Antibiotic prophylaxis, standard before cesarean delivery, is associated with less post-cesarean infection if azithromycin is added to the standard cefazolin. In this placebo-controlled pilot trial, investigators will estimate the parameters necessary to calculate the sample size for a planned multicenter clinical trial of prophylactic antibiotics administered at the start of labor inductions of morbidly obese nulliparous women at term.

Conditions

Obesity; Induction of Labor Affected Fetus / Newborn

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Cesarean Delivery

  Rate at which women give birth via cesarean section

  30 days after delivery

• Number of Participants With Puerperal Infections

  Chorioamnionitis, endometritis and/or cesarean wound infection

  30 days after delivery

Secondary Outcomes (6)

• Number of Participants With Postpartum Hemorrhage

  30 days after delivery

• Number of Participants Who Underwent A Blood Transfusion

  30 days after delivery

• Number of Participants With ICU Admission

  30 days after delivery

• Number of Participants With Maternal Hospital Readmission

  30 days after delivery

• Primary Indications for Cesarean Delivery

  30 days after delivery

Study Arms (2)

Cefazolin + Azithromycin

EXPERIMENTAL

Women will be randomized 1:1 to receive cefazolin 2 grams intravenously at the start of the labor induction and every 8 hours thereafter for a maximum of three doses and azithromycin 500 mg intravenously once at the start of the labor induction

Drug: Cefazolin; Drug: Azithromycin

Placebo + Placebo

PLACEBO COMPARATOR

Women will be randomized 1:1 to receive placebo intravenously at the start of the labor induction and every 8 hours thereafter for a maximum of three doses and placebo intravenously once at the start of the labor induction

Drug: Placebo

Interventions

Cefazolin DRUG

intravenous drugs used as prophylactic antibiotics

Cefazolin + Azithromycin

Placebo DRUG

Intravenous saline

Also known as: Saline

Placebo + Placebo

Azithromycin DRUG

prophylactic antibiotic

Cefazolin + Azithromycin

Eligibility Criteria

• Age: 15 Years - 45 Years
• Gender Eligibility Details: Women of child-bearing age
• Healthy Volunteers: Yes
• 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

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 either drug used in the protocol (cefazolin or azithromycin)

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Related Publications (1)

• Pierce SL, Peck JD, Zornes C, Standerfer E, Edwards RK. Antibiotic Prophylaxis to Prevent Obesity-Related Induction Complications in Nulliparae at Term: a pilot randomized controlled trial. Am J Obstet Gynecol MFM. 2022 Sep;4(5):100681. doi: 10.1016/j.ajogmf.2022.100681. Epub 2022 Jun 18.

  PMID: 35728781 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Cefazolin; Sodium Chloride; Azithromycin

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Erythromycin; Macrolides; Polyketides; Lactones

Results Point of Contact

• Title: Dr. Stephanie Pierce
• Organization: University of Oklahoma Health Sciences Center

stephanie-pierce@ouhsc.edu

(405) 271-8787

Study Officials

• Stephanie Pierce, MD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: One arm includes double placebo drugs that will be blinded from the investigator and participant
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled clinical trial

Study Record Dates

• First Submitted: January 9, 2019
• First Posted: January 11, 2019
• Study Start: December 12, 2018
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: April 19, 2024
• Results First Posted: April 19, 2024

Record last verified: 2023-11

Locations

US (1)