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

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

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

Brief 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.

Detailed Summary:
Sponsor: University of Missouri, Kansas City

Current Primary Outcome: Development of post cesarean endometritis [ Time Frame: 3-4 days while in hospital during post partum period ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Hospital stay length [ Time Frame: 3-4 days while in hospital during post partum period ]

Original Secondary Outcome: Same as current

Information By: University of Missouri, Kansas City

Dates:
Date Received: November 1, 2012
Date Started: November 2012
Date Completion:
Last Updated: May 4, 2015
Last Verified: May 2015