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| 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 |
| 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
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Patrick Duff, M.D. | 532-573-7673 | duffp@obgyn.ufl.edu |
| Contact: Lorna Rodriguez, M.D. | 571-242-9780 | lrodriguez3@obgyn.ufl.edu |
| 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. | |
| Principal Investigator: | Patrick Duff, M.D. | Obstetrics and Gynecology |
| Principal Investigator: | Lorna Rodriguez, M.D. | Obstetrics and Gynecology |
More Information
| 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 |
|
Anti-Infective Agents Anti-Bacterial Agents Therapeutic Uses Infection Pharmacologic Actions |