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Trial record 8 of 20 for:    "Endometritis" | "Anti-Bacterial Agents"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01721616
Recruitment Status : Withdrawn (Poor enrollment)
First Posted : November 6, 2012
Last Update Posted : May 5, 2015
Information provided by (Responsible Party):
Pedro Morales-Ramirez, 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.

Condition or disease Intervention/treatment Phase
Endometritis Drug: Azithromycin Drug: Cefazolin Phase 4

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Study Type : Interventional  (Clinical Trial)
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 : November 2012
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Development of post cesarean endometritis [ Time Frame: 3-4 days while in hospital during post partum period ]

Secondary Outcome Measures :
  1. Hospital stay length [ Time Frame: 3-4 days while in hospital during post partum period ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01721616

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United States, Missouri
Truman Medical Center - Hospital Hill
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
University of Missouri, Kansas City
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Principal Investigator: Pedro Morales, MD University of Missouri, Kansas City
Principal Investigator: Katherine Goodpasture, DO University of Missouri, Kansas City

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Responsible Party: Pedro Morales-Ramirez, MD, University of Missouri, Kansas City Identifier: NCT01721616     History of Changes
Other Study ID Numbers: 12-13
First Posted: November 6, 2012    Key Record Dates
Last Update Posted: May 5, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Pelvic Inflammatory Disease
Adnexal Diseases
Genital Diseases, Female
Uterine Diseases
Anti-Bacterial Agents
Anti-Infective Agents