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

NCT01721616 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2015-05-05

No results posted yet for this study

Summary

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.

Conditions

  • Endometritis

Interventions

DRUG

Azithromycin

DRUG

Cefazolin

Sponsors & Collaborators

  • University of Missouri, Kansas City

    lead OTHER

Principal Investigators

  • Pedro Morales, MD · University of Missouri, Kansas City

  • Katherine Goodpasture, DO · University of Missouri, Kansas City

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2014-11-30
Completion
2014-11-30

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01721616 on ClinicalTrials.gov