The Timing of Prophylactic Antibiotics in Cesarean Section and the Risk of Post-operative Febrile Morbidity

Phase 4

Terminated

• Conditions: Cesarean Section

• Registration Number: NCT00133029
• Lead Sponsor: University of Pennsylvania

Brief Summary

The purpose of this study is to determine whether the timing of prophylactic antibiotic administration for cesarean section (immediate preoperative versus intraoperative administration) impacts the rate of postoperative febrile morbidity. The specific aim of the project is to test the hypothesis that preoperative antibiotic administration will decrease the rate of composite postoperative febrile morbidity.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-07
• Study First Submitted: 2005-08-19
• Study First Submitted QC: 2005-08-19
• Study First Posted: 2005-08-22
• Primary Completion: 2006-07
• Study Completion: 2006-07
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-12
• Last Update Posted: 2016-08-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• Gestational age > 36 weeks
• Ability to understand requirements of the study
• Elective/non-emergent cesarean section selected as route of delivery by treating physicians

Exclusion Criteria

• Known fetal anomaly
• Exposure to antibiotics within 7 days of admission, including intrapartum group B streptococcal (GBS) prophylaxis
• Emergent cesarean delivery (i.e. for fetal distress, maternal distress, obstetric hemorrhage)
• Overt maternal intrapartum infection requiring antibiotics
• Prolonged rupture of membranes (>18 hours)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (1)

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States