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Trial Comparing the Optimal Timing of Antibiotic Prophylaxis at the Time of Cesarean Delivery

This study has been completed.
Sponsor:
Collaborator:
University of California, Irvine
Information provided by:
MemorialCare
ClinicalTrials.gov Identifier:
NCT00811603
First received: December 17, 2008
Last updated: September 17, 2009
Last verified: September 2009
History of Changes
  Purpose

The purpose of this study is to evaluate the rates of maternal and neonatal infectious morbidity in gravid patients undergoing cesarean delivery. Specifically, the investigators are examining whether the timing of antibiotic administration has any effect on rates of maternal and neonatal infections, neonatal sepsis work-up and length of hospital stay.


Condition Intervention Phase
Cesarean Section
Infection
 Drug: Cefazolin (Timing of Antibiotic Prophylaxis)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Optimal Timing for Antibiotic Prophylaxis for Elective Cesarean Delivery in Term Gestations: A Randomized, Controlled Trial Comparing Cefazolin Administration Prior to Skin Incision Versus Following Cord Clamping

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by MemorialCare:

Primary Outcome Measures:
  • To assess the rates of maternal infectious morbidity with preoperative administration of antibiotics when compared to antibiotic prophylaxis given following umbilical cord clamping [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To assess incidence of neonatal infectious morbidity (i.e. rates of sepsis work-up, confirmed sepsis, and length of hospital stay) between two study arms [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 50
Study Start Date: August 2008
Study Completion Date: September 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Patients who receive antibiotic prophylaxis after clamping of the umbilical cord
 Drug: Cefazolin (Timing of Antibiotic Prophylaxis)
Patients scheduled for a cesarean delivery will be randomly assigned to receive Cefazolin (antibiotic prophylaxis) either prior to skin incision or after the clamping of the umbilical cord
Experimental: 2
Patients who receive antibiotic prophylaxis prior to skin incision
 Drug: Cefazolin (Timing of Antibiotic Prophylaxis)
Patients scheduled for a cesarean delivery will be randomly assigned to receive Cefazolin (antibiotic prophylaxis) either prior to skin incision or after the clamping of the umbilical cord

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients 18 years of age or older
  • Any patient at term (>37 weeks gestation) undergoing a scheduled cesarean delivery

Exclusion Criteria:

  • Women younger than 18 years
  • Patients who are febrile during or prior to screening or with a diagnosis of clinical suspicion of endometritis (with or without maternal fever)
  • Patients who present with ruptured membranes
  • Known fetal malformations
  • Contraindications to cefazolin administration (known anaphylactic reaction to penicillins or known cephalosporin allergy)
  • Any exposure to antibiotics in one week prior to cesarean delivery
  • Obstetrical indication for an emergent cesarean delivery
  • Patients taking glucocorticoids or other immunosuppressant therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00811603

Locations
United States, California
Long Beach Memorial Medical Center
Long Beach, California, United States, 90806
University of California, Irvine Medical Center
Orange, California, United States, 92868
Sponsors and Collaborators
MemorialCare
University of California, Irvine
Investigators
Principal Investigator: Kenneth Chan, MD Memorial Medical Center
  More Information

No publications provided

Responsible Party: Leo Pevzner, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00811603     History of Changes
Other Study ID Numbers: 474-07
Study First Received: December 17, 2008
Last Updated: September 17, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by MemorialCare:
Antibiotic
Prophylaxis
Cesarean
Infection
Antibiotic prophylaxis

Additional relevant MeSH terms:
Anti-Bacterial Agents
Cefazolin
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013