Suspended

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

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What is being tested

Azithromycin

+ Cefazolin

Drug
Who is being recruted

Urogenital Diseases+6

+ Genital Diseases

+ Adnexal Diseases

+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Phase 4
Interventional
Study Start: November 2012
See protocol details

Summary

Principal SponsorUniversity of Missouri, Kansas City
Last updated: January 27, 2026
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Study start date: November 1, 2012

Actual date on which the first participant was enrolled.

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.

Official TitleA Randomized Clinical Trial of Cefazolin Versus Cefazolin Plus Azithromycin Prophylaxis in Post-Cesarean Endometritis
Principal SponsorUniversity of Missouri, Kansas City
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesAdnexal DiseasesPelvic Inflammatory DiseaseEndometritisFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleUterine DiseasesFemale Urogenital Diseases

Criteria

4 inclusion criteria required to participate
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.

7 exclusion criteria prevent from participating
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.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
double antibiotic

Group II

Active Comparator
single antibiotic

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Truman Medical Center - Hospital Hill

Kansas City, United StatesOpen Truman Medical Center - Hospital Hill in Google Maps
SuspendedOne Study Center