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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2014-11-30

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.

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Detailed Description

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Conditions

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Endometritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cefazolin

single antibiotic

Group Type ACTIVE_COMPARATOR

Cefazolin

Intervention Type DRUG

Cefazolin + Azitrhromycin

double antibiotic

Group Type ACTIVE_COMPARATOR

Azithromycin

Intervention Type DRUG

Cefazolin

Intervention Type DRUG

Interventions

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Azithromycin

Intervention Type DRUG

Cefazolin

Intervention Type DRUG

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.

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No