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NCT00133029 Clinical Trial

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

Cesarean Section Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00133029
Other study ID # 705719
Secondary ID
Status Terminated
Phase Phase 4
First received August 19, 2005
Last updated August 12, 2016
Start date July 2004
Est. completion date July 2006

Study information
Verified date August 2016
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 0
Est. completion date July 2006
Est. primary completion date July 2006
Accepts healthy volunteers
Gender Female
Age group N/A and older
Eligibility 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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Drug:
• Timing of prophylactic antibiotic administration

Locations
Country Name City State
United States Hospital of the University of Pennsylvania Philadelphia Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

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