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

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ClinicalTrials.gov Identifier: NCT00133029
Recruitment Status : Terminated
First Posted : August 22, 2005
Last Update Posted : August 15, 2016
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Cesarean Section Drug: Timing of prophylactic antibiotic administration Phase 4

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Study Start Date : July 2004
Actual Primary Completion Date : July 2006
Actual Study Completion Date : July 2006

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Ages Eligible for Study:   Child, Adult, Older Adult
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)

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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

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

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