Trial Comparing the Optimal Timing of Antibiotic Prophylaxis at the Time of Cesarean Delivery - Full Text View

Sponsor:	MemorialCare
Collaborator:	University of California, Irvine
Information provided by:	MemorialCare
ClinicalTrials.gov Identifier:	NCT00811603

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 III

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:

MedlinePlus related topics: Antibiotics Cesarean Section Sepsis

Drug Information available for: Cefazolin Cefazolin sodium

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

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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 February 09, 2012