Clinical trial NCT00805545: Timing of Antibiotic Prophylaxis for Cesarean Deliveries
Official title: The Timing of Antibiotic Prophylaxis for Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infection
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2008-12-09
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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 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

Primary outcomes:
measure: Endometritis and Wound Infection
timeFrame: Patients were followed from the time of surgery until 6 weeks postpartum.
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Shands Hospital
state: Florida
Study officials:
affiliation: Obstetrics and Gynecology
name: Patrick Duff, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Obstetrics and Gynecology
name: Lorna Rodriguez, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Duff P. Prophylactic antibiotics for cesarean delivery: a simple cost-effective strategy for prevention of postoperative morbidity. Am J Obstet Gynecol. 1987 Oct;157(4 Pt 1):794-8. doi: 10.1016/s0002-9378(87)80057-1.
citation: Tita AT, Hauth JC, Grimes A, Owen J, Stamm AM, Andrews WW. Decreasing incidence of postcesarean endometritis with extended-spectrum antibiotic prophylaxis. Obstet Gynecol. 2008 Jan;111(1):51-6. doi: 10.1097/01.AOG.0000295868.43851.39.
citation: Burke JF. The effective period of preventive antibiotic action in experimental incisions and dermal lesions. Surgery. 1961 Jul;50:161-8.
citation: Sullivan SA, Smith T, Chang E, Hulsey T, Vandorsten JP, Soper D. Administration of cefazolin prior to skin incision is superior to cefazolin at cord clamping in preventing postcesarean infectious morbidity: a randomized, controlled trial. Am J Obstet Gynecol. 2007 May;196(5):455.e1-5. doi: 10.1016/j.ajog.2007.03.022.
citation: Gordon HR, Phelps D, Blanchard K. Prophylactic cesarean section antibiotics: maternal and neonatal morbidity before or after cord clamping. Obstet Gynecol. 1979 Feb;53(2):151-6.
citation: Cunningham FG, Leveno KJ, DePalma RT, Roark M, Rosenfeld CR. Perioperative antimicrobials for cesarean delivery: before or after cord clamping? Obstet Gynecol. 1983 Aug;62(2):151-4.
citation: Thigpen BD, Hood WA, Chauhan S, Bufkin L, Bofill J, Magann E, Morrison JC. Timing of prophylactic antibiotic administration in the uninfected laboring gravida: a randomized clinical trial. Am J Obstet Gynecol. 2005 Jun;192(6):1864-8; discussion 1868-71. doi: 10.1016/j.ajog.2004.12.063.