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

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: Female

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 the timing of antibiotic administration has any effect on rates of maternal and neonatal infections, neonatal sepsis work-up and length of hospital stay.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: MemorialCare
• Collaborator: University of California, Irvine
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Cefazolin

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