Timing of Antibiotic Prophylaxis for Cesarean Deliveries

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00805545
First received: December 5, 2008
Last updated: March 19, 2012
Last verified: March 2012
  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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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:
  • Endometritis and Wound Infection [ Time Frame: Patients were followed from the time of surgery until 6 weeks postpartum. ] [ Designated as safety issue: No ]
    In non-pregnant patients having certain types of surgery with a high risk of infection, prophylactic antibiotics are routinely administered before the surgical procedure begins to ensure that a high level of antibiotic is present in tissue prior to the time that maximum bacterial contamination occurs. However, there has been concern about exposing the fetus in utero to antibiotics. The question to be addressed was whether preoperative antibiotics (as opposed to antibiotics administered after clamping of the umbilical cord) benefitted the mother without increasing risk for the baby.


Enrollment: 400
Study Start Date: November 2008
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Group of patients that will receive antibiotics 30-60 minutes prior to incision
Drug: Antibiotic
Cefazolin 1gm Intravenously and Azithromycin 500mg Intravenously
Active Comparator: B
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00805545

Locations
United States, Florida
Shands Hospital
Gainesville, Florida, United States, 32610
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: University of Florida
ClinicalTrials.gov Identifier: NCT00805545     History of Changes
Other Study ID Numbers: C/S- Antibiotics
Study First Received: December 5, 2008
Results First Received: February 3, 2012
Last Updated: March 19, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 28, 2014