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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00133029
First Posted: August 22, 2005
Last Update Posted: August 15, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Pennsylvania
  Purpose
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.

Condition Intervention Phase
Cesarean Section Drug: Timing of prophylactic antibiotic administration Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Study Start Date: July 2004
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00133029


Locations
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: George A. Macones, MD, MSCE University of Pennsylvania
  More Information

ClinicalTrials.gov Identifier: NCT00133029     History of Changes
Other Study ID Numbers: 705719
First Submitted: August 19, 2005
First Posted: August 22, 2005
Last Update Posted: August 15, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents