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

This study has been terminated.
Sponsor:
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00133029
First received: August 19, 2005
Last updated: September 7, 2006
Last verified: September 2006
  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: Open Label

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

  Eligibility

Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00133029     History of Changes
Other Study ID Numbers: 705719
Study First Received: August 19, 2005
Last Updated: September 7, 2006
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014