Timing of Antibiotic Prophylaxis for Cesarean Deliveries

NCT00805545 | Completed Results

• 1 other identifier: C/S- Antibiotics
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Infection

Outcome Measures

Primary Outcomes (1)

• Endometritis and Wound Infection

  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.

  Patients were followed from the time of surgery until 6 weeks postpartum.

Study Arms (2)

A

EXPERIMENTAL

Group of patients that will receive antibiotics 30-60 minutes prior to incision

Drug: Antibiotic

B

ACTIVE COMPARATOR

Group of patients that will receive antibiotics immediately after clamping the umbilical cord

Drug: Antibiotic

Interventions

Antibiotic DRUG

Cefazolin 1gm Intravenously and Azithromycin 500mg Intravenously

A

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• All Patients undergoing cesarean delivery

You may not qualify if:

• Patients diagnosed with chorioamnionitis at the time of decision
• Patients that require an emergency cesarean delivery
• Patients that decline participating on the study

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

Shands Hospital

Gainesville, Florida, 32610, United States

Location

Related Publications (7)

• 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.

  PMID: 3118716 BACKGROUND

• 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.

  PMID: 18165392 BACKGROUND

• Burke JF. The effective period of preventive antibiotic action in experimental incisions and dermal lesions. Surgery. 1961 Jul;50:161-8.

  PMID: 16722001 BACKGROUND

• 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.

  PMID: 17466699 BACKGROUND

• 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.

  PMID: 418966 BACKGROUND

• 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.

  PMID: 6866355 BACKGROUND

• 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.

  PMID: 15970833 BACKGROUND

MeSH Terms

Conditions

Infections

Interventions

Anti-Bacterial Agents

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Limitations and Caveats

There were no limitations to the study. No technical problems occurred during the study.

Results Point of Contact

• Title: Patrick Duff, M.D.
• Organization: University of Florida

duffp@ufl.edu

352 273 7673

Study Officials

• Patrick Duff, M.D.

  Obstetrics and Gynecology

  PRINCIPAL INVESTIGATOR

• Lorna Rodriguez, M.D.

  Obstetrics and Gynecology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2008
• First Posted: December 9, 2008
• Study Start: November 1, 2008
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: April 16, 2012
• Results First Posted: April 16, 2012

Record last verified: 2012-03

Locations

US (1)