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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.
Information provided by:
University of Pennsylvania Identifier:
First received: August 19, 2005
Last updated: August 12, 2016
Last verified: August 2016
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)

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

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
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Please refer to this study by its identifier: NCT00133029

United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Principal Investigator: George A. Macones, MD, MSCE University of Pennsylvania
  More Information Identifier: NCT00133029     History of Changes
Other Study ID Numbers: 705719
Study First Received: August 19, 2005
Last Updated: August 12, 2016

Additional relevant MeSH terms:
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents processed this record on August 18, 2017