Clinical trial NCT01721616: Comparison Study of Cefazolin Versus Cefazolin Plus Azithromycin Prophylaxis in Post-Cesarean Endometritis
Official title: A Randomized Clinical Trial of Cefazolin Versus Cefazolin Plus Azithromycin Prophylaxis in Post-Cesarean Endometritis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Endometritis
Lead sponsor: University of Missouri, Kansas City
Sponsor class: OTHER
First posted: 2012-11-06
Enrollment: 0
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Development of post cesarean endometritis
timeFrame: 3-4 days while in hospital during post partum period
Secondary outcomes:
measure: Hospital stay length
timeFrame: 3-4 days while in hospital during post partum period
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Truman Medical Center - Hospital Hill
state: Missouri
Study officials:
affiliation: University of Missouri, Kansas City
name: Pedro Morales, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Missouri, Kansas City
name: Katherine Goodpasture, DO
role: PRINCIPAL_INVESTIGATOR
References: