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Timing of Antibiotic Prophylaxis for Cesarean Deliveries
This study is currently recruiting participants.
Verified by University of Florida, December 2008
First Received: December 5, 2008   No Changes Posted
Sponsor: University of Florida
Information provided by: University of Florida
ClinicalTrials.gov Identifier: NCT00805545
  Purpose

The current standard of care to prevent post partum infectious morbidities is to administer antibiotic prophylaxis to all women undergoing a cesarean delivery. The general practice is to administer the antibiotic immediately after the umbilical cord is clamped. This study will compare the incidence of post partum infectious morbidities when the extended spectrum prophylaxis given before the incision time vs. the time of cord clamp.


Condition Intervention
Infection
Drug: Antibiotic

Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title: The Timing of Antibiotic Prophylaxis for Cesarean Delivery

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Frequency of endometritis, wound infection, neonatal sepsis evaluations, proven neonatal infection [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of patients requiring antibiotic treatment after the cesarean delivery, duration of hospitalization for mother and neonate, pattern of antibiotic resistance in microorganisms isolated, characteristics of neonatal bowel flora [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: November 2008
Estimated Study Completion Date: November 2009
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental
Group of patients that will receive antibiotics 30-60 minutes prior to incision
Drug: Antibiotic
Cefazolin 1gm Intravenously and Azithromycin 500mg Intravenously
B: Active Comparator
Group of patients that will receive antibiotics immediately after clamping the umbilical cord
Drug: Antibiotic
Cefazolin 1gm Intravenously and Azithromycin 500mg Intravenously

Detailed Description:

Some studies suggest that administering the antibiotics prior to skin incision decrease the incidence of post partum infectious morbidities without increasing the risks to the baby from the exposure to the antibiotics. Our investigation will validate these findings in a larger series of patients. We will be conducting a prospective controlled randomized trial that will compare both methods of antibiotic prophylaxis. All patients undergoing cesarean delivery will be eligible except for the patients with the diagnosis of chorioamnionitis. One group will receive Cefazolin 1gm intravenous + Azithromycin 500mg intravenous 30-60 minutes prior to incision. The second group will receive the same antibiotics immediately after cord clamp. The primary outcomes will be endometritis, wound infection, neonatal sepsis evaluations, proven cases of neonatal infection. Secondary outcomes will be patients that required post procedure antibiotics, the duration of treatment for mother and neonate and the pattern of antibiotic resistance in microorganisms isolated and characteristics of the neonatal bowel flora.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All Patients undergoing cesarean delivery

Exclusion Criteria:

  • Patients diagnosed with chorioamnionitis at the time of decision
  • Patients that require an emergency cesarean delivery
  • Patients that decline participating on the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00805545

Contacts
Contact: Patrick Duff, M.D. 532-573-7673 duffp@obgyn.ufl.edu
Contact: Lorna Rodriguez, M.D. 571-242-9780 lrodriguez3@obgyn.ufl.edu

Locations
United States, Florida
Shands Hospital Recruiting
Gainesville, Florida, United States, 32610
Contact: Patrick Duff, M.D.     352-273-7673     duffp@obgyn.ufl.edu    
Contact: Lorna Rodriguez, M.D.     571-242-9780     lrodriguez3@obgyn.ufl.edu    
Principal Investigator: Patrick Duff, M.D.            
Sub-Investigator: Rodriguez Lorna, M.D.            
Sub-Investigator: Kriste Thorpe, M.D.            
Sub-Investigator: David Burchfield, M.D.            
Sub-Investigator: Josef Neu, M.D.            
Sub-Investigator: Volker Mai, Ph.D.            
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Patrick Duff, M.D. Obstetrics and Gynecology
Principal Investigator: Lorna Rodriguez, M.D. Obstetrics and Gynecology
  More Information

Publications:
Responsible Party: Patrick Duff, M.D.- Principal Investigator ( Patrick Duff, M.D.- Principal Investigator )
Study ID Numbers: C/S- Antibiotics
Study First Received: December 5, 2008
Last Updated: December 5, 2008
ClinicalTrials.gov Identifier: NCT00805545     History of Changes
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-Bacterial Agents
Therapeutic Uses
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2010