Status:
COMPLETED
Trial Comparing the Optimal Timing of Antibiotic Prophylaxis at the Time of Cesarean Delivery
Lead Sponsor:
MemorialCare
Collaborating Sponsors:
University of California, Irvine
Conditions:
Cesarean Section
Infection
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
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 ...
Detailed Description
Nearly fifty years have passed since Burke et al first demonstrated in animal model the reduction of infection rates in contaminated skin incisions with administration of antibiotic prophylaxis. Furth...
Eligibility Criteria
Inclusion
- Patients 18 years of age or older
- Any patient at term (\>37 weeks gestation) undergoing a scheduled cesarean delivery
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00811603
Start Date
August 1 2008
End Date
September 1 2009
Last Update
September 18 2009
Active Locations (2)
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1
Long Beach Memorial Medical Center
Long Beach, California, United States, 90806
2
University of California, Irvine Medical Center
Orange, California, United States, 92868