Comparison Study of Cefazolin Versus Cefazolin Plus Azithromycin Prophylaxis in Post-Cesarean Endometritis
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/8/2014 |
| Start Date: | November 2012 |
| End Date: | November 2014 |
| Contact: | Pedro Morales-ramirez, MD |
| Email: | Pedro.Morales-Ramirez@tmcmed.org |
| Phone: | 816-404-5150 |
A Randomized Clinical Trial of Cefazolin Versus Cefazolin Plus Azithromycin Prophylaxis in Post-Cesarean Endometritis
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.
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.
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.
We found this trial at
1
site
Click here to add this to my saved trials
