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

Study Overview
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Brief Summary
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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 Title
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A Randomized Clinical Trial of Cefazolin Versus Cefazolin Plus Azithromycin Prophylaxis in Post-Cesarean Endometritis

Conditions
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Endometritis

Intervention / Treatment
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* Drug: Azithromycin
* Drug: Cefazolin


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cefazolin<br>single antibiotic | Drug: Cefazolin<br> <br> |
| Active Comparator: Cefazolin + Azitrhromycin<br>double antibiotic | Drug: Azithromycin<br> <br> Drug: Cefazolin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of post cesarean endometritis |  | 3-4 days while in hospital during post partum period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital stay length |  | 3-4 days while in hospital during post partum period |