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

Primary Purpose

Endometritis

Status

Withdrawn

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Azithromycin

Cefazolin

About this trial

This is an interventional prevention trial for Endometritis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

Truman Medical Center - Hospital Hill

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Cefazolin

Cefazolin + Azitrhromycin

Arm Description

single antibiotic

double antibiotic

Outcomes

Primary Outcome Measures

Development of post cesarean endometritis

Secondary Outcome Measures

Hospital stay length

Full Information

NCT ID

NCT01721616

First Posted

November 1, 2012

Last Updated

May 4, 2015

Sponsor

University of Missouri, Kansas City

1. Study Identification

Unique Protocol Identification Number

NCT01721616

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Withdrawn

Why Stopped

Poor enrollment

Study Start Date

November 2012 (undefined)

Primary Completion Date

November 2014 (Actual)

Study Completion Date

November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Missouri, Kansas City

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Endometritis

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cefazolin

Arm Type

Active Comparator

Arm Description

single antibiotic

Arm Title

Cefazolin + Azitrhromycin

Arm Type

Active Comparator

Arm Description

double antibiotic

Intervention Type

Drug

Intervention Name(s)

Azithromycin

Intervention Type

Drug

Intervention Name(s)

Cefazolin

Primary Outcome Measure Information:

Title

Development of post cesarean endometritis

Time Frame

3-4 days while in hospital during post partum period

Secondary Outcome Measure Information:

Title

Hospital stay length

Time Frame

3-4 days while in hospital during post partum period

10. Eligibility

Sex

Female

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pedro Morales, MD

Organizational Affiliation

University of Missouri, Kansas City

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Katherine Goodpasture, DO

Organizational Affiliation

University of Missouri, Kansas City

Official's Role

Principal Investigator

Facility Information:

Facility Name

Truman Medical Center - Hospital Hill

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64108

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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