Comparison Study of Cefazolin Versus Cefazolin Plus Azithromycin Prophylaxis in Post-Cesarean Endometritis

May 4, 2015 updated by: Pedro Morales-Ramirez, University of Missouri, Kansas City

A Randomized Clinical Trial of Cefazolin Versus Cefazolin Plus Azithromycin Prophylaxis in Post-Cesarean Endometritis

Despite the generalized use of preoperative antibiotic prophylaxis, endometritis remains as the most frequent post-cesarean delivery complication. This increased morbidity translates into extended post-partum antibiotic use and prolongation of hospital stay with the subsequent increase in health care expenses. The current regimen recommended by the American College of Obstetricians and Gynecologists for cesarean delivery prophylaxis (1st generation cephalosporins) does not cover for Ureaplasma Urealyticum, a microorganism that has been associated with an increased risk of endometritis in post-cesarean section patients. Azithromycin, an antibiotic that has both aerobic and some anaerobic coverage, uniquely covers Ureaplasma and would be an excellent second antibiotic for cesarean section chemoprophylaxis. Our hypothesis is that the addition of azithromycin to standard chemoprophylaxis with cefazolin can effect a 25% reduction of post-cesarean section endometritis.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Truman Medical Center - Hospital Hill

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pregnant patients between 37 and 42 weeks gestational weeks.
  • Pregnant patients undergoing indicated cesarean section at Truman Medical Center Hospital July 2012 and July 2014.
  • Pregnant patient that received prenatal care at Truman Medical Center. Hospital Hill, Samuel Rogers or Swope Parkway health centers at least 1 month prior to the Cesarean delivery.
  • Signed informed consent.

Exclusion Criteria:

  • Allergy to cephalosporins or azithromycin.
  • Refusal to sign consent form.
  • Clinical signs of chorioamnionitis: fever 100.4 F or higher, uterine tenderness, maternal or fetal tachycardia.
  • Immunocompromised condition: HIV positive with CD4 count below 200, chronic steroid use, pregestational diabetes, cancer, chemotherapy.
  • Need for emergent cesarean precluding consent or availability of study medication.
  • Need for hysterectomy at cesarean section.
  • Use of antibiotic in the 72 hours prior to admission.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cefazolin
single antibiotic
Drug: Cefazolin
Active Comparator: Cefazolin + Azitrhromycin
double antibiotic
Drug: Azithromycin
Drug: Cefazolin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Development of post cesarean endometritis
Time Frame: 3-4 days while in hospital during post partum period
3-4 days while in hospital during post partum period

Secondary Outcome Measures

Outcome Measure
Time Frame
Hospital stay length
Time Frame: 3-4 days while in hospital during post partum period
3-4 days while in hospital during post partum period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Missouri, Kansas City

Investigators

  • Principal Investigator: Pedro Morales, MD, University of Missouri, Kansas City
  • Principal Investigator: Katherine Goodpasture, DO, University of Missouri, Kansas City

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

November 1, 2012

First Submitted That Met QC Criteria

November 1, 2012

First Posted (Estimate)

November 6, 2012

Study Record Updates

Last Update Posted (Estimate)

May 5, 2015

Last Update Submitted That Met QC Criteria

May 4, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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