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

Phase 4

Withdrawn

• Conditions: Endometritis
• Interventions: Drug: Azithromycin; Drug: Cefazolin

• Registration Number: NCT01721616
• Lead Sponsor: University of Missouri, Kansas City

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 Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-01
• Study First Submitted QC: 2012-11-01
• Study First Posted: 2012-11-06
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-04
• Last Update Posted: 2015-05-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cefazolin + Azitrhromycin	Azithromycin	double antibiotic
Cefazolin	Cefazolin	single antibiotic
Cefazolin + Azitrhromycin	Cefazolin	double antibiotic

Primary Outcome Measures

Name	Time	Method
Development of post cesarean endometritis	3-4 days while in hospital during post partum period

Secondary Outcome Measures

Name	Time	Method
Hospital stay length	3-4 days while in hospital during post partum period

Trial Locations

Locations (1)

Truman Medical Center - Hospital Hill; 🇺🇸 Kansas City, Missouri, United States