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

Sponsor

University of Missouri, Kansas City (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01721616

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Endometritis	Drug: Azithromycin Drug: Cefazolin	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Nov 1, 2012

Actual Primary Completion Date :

Nov 1, 2014

Actual Study Completion Date :

Nov 1, 2014

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Cefazolin

single antibiotic

Drug: Cefazolin

Active Comparator: Cefazolin + Azitrhromycin

double antibiotic

Drug: Azithromycin

Drug: Cefazolin

Outcome Measures

Primary Outcome Measures

Development of post cesarean endometritis [3-4 days while in hospital during post partum period]

Secondary Outcome Measures

Hospital stay length [3-4 days while in hospital during post partum period]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Truman Medical Center - Hospital Hill	Kansas City	Missouri	United States	64108

Sponsors and Collaborators

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pedro Morales-Ramirez, MD, University of Missouri, Kansas City

ClinicalTrials.gov Identifier:

NCT01721616

Other Study ID Numbers:

12-13

First Posted:

Nov 6, 2012

Last Update Posted:

May 5, 2015

Last Verified:

May 1, 2015

Additional relevant MeSH terms:

Endometritis

Azithromycin

Cefazolin

Study Results

No Results Posted as of May 5, 2015