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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by University of Missouri, Kansas City
Sponsor:
Information provided by (Responsible Party):
Pedro Morales-Ramirez, University of Missouri, Kansas City
ClinicalTrials.gov Identifier:
NCT01721616
First received: November 1, 2012
Last updated: September 22, 2013
Last verified: September 2013
  Purpose

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 Intervention Phase
Endometritis
Drug: Azithromycin
Drug: Cefazolin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized Clinical Trial of Cefazolin Versus Cefazolin Plus Azithromycin Prophylaxis in Post-Cesarean Endometritis

Resource links provided by NLM:


Further study details as provided by University of Missouri, Kansas City:

Primary Outcome Measures:
  • Development of post cesarean endometritis [ Time Frame: 3-4 days while in hospital during post partum period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hospital stay length [ Time Frame: 3-4 days while in hospital during post partum period ] [ Designated as safety issue: No ]

Estimated Enrollment: 506
Study Start Date: November 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cefazolin
single antibiotic
Drug: Cefazolin
Active Comparator: Cefazolin + Azitrhromycin
double antibiotic
Drug: Azithromycin Drug: Cefazolin

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01721616

Contacts
Contact: Pedro Morales-ramirez, MD 816-404-5150 Pedro.Morales-Ramirez@tmcmed.org
Contact: Eunice Riddle, LPN 816-404-5713 Eunice.riddle@atmcmed.org

Locations
United States, Missouri
Truman Medical Center - Hospital Hill Recruiting
Kansas City, Missouri, United States, 64108
Principal Investigator: Pedro Morales, MD         
Sub-Investigator: Katherine Goodpasture, DO         
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
  More Information

No publications provided

Responsible Party: Pedro Morales-Ramirez, MD, University of Missouri, Kansas City
ClinicalTrials.gov Identifier: NCT01721616     History of Changes
Other Study ID Numbers: 12-13
Study First Received: November 1, 2012
Last Updated: September 22, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Pelvic Inflammatory Disease
Endometritis
Adnexal Diseases
Genital Diseases, Female
Uterine Diseases
Cefazolin
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 11, 2014