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

Endometritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01721616
• Other study ID #: 12-13
• Status: Withdrawn
• Phase: Phase 4
• First received: November 1, 2012
• Last updated: May 4, 2015
• Start date: November 2012
• Est. completion date: November 2014

Study information

• Verified date: May 2015
• Source: University of Missouri, Kansas City
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Endometritis

Intervention

Drug:
• Azithromycin

• Cefazolin

Locations

Country	Name	City	State
United States	Truman Medical Center - Hospital Hill	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri, Kansas City

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of post cesarean endometritis		3-4 days while in hospital during post partum period	No
Secondary	Hospital stay length		3-4 days while in hospital during post partum period	No