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

NCT01721616 | Withdrawn Phase 4

• 1 other identifier: 12-13
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometritis

Outcome Measures

Primary Outcomes (1)

• Development of post cesarean endometritis

  3-4 days while in hospital during post partum period

Secondary Outcomes (1)

• Hospital stay length

  3-4 days while in hospital during post partum period

Study Arms (2)

Cefazolin

ACTIVE COMPARATOR

single antibiotic

Drug: Cefazolin

Cefazolin + Azitrhromycin

ACTIVE COMPARATOR

double antibiotic

Drug: Azithromycin; Drug: Cefazolin

Interventions

Azithromycin DRUG

Cefazolin + Azitrhromycin

Cefazolin DRUG

Cefazolin; Cefazolin + Azitrhromycin

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Missouri, Kansas City: lead

Study Sites (1)

Truman Medical Center - Hospital Hill

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

Endometritis

Interventions

Azithromycin; Cefazolin

Condition Hierarchy (Ancestors)

Pelvic Inflammatory Disease; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Uterine Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Cephalosporins; beta-Lactams; Lactams; Amides; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Pedro Morales, MD

  University of Missouri, Kansas City

  PRINCIPAL INVESTIGATOR

• Katherine Goodpasture, DO

  University of Missouri, Kansas City

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 1, 2012
• First Posted: November 6, 2012
• Study Start: November 1, 2012
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: May 5, 2015

Record last verified: 2015-05

Locations

US (1)