Serum and Tissue Cefazolin Concentrations in Normal Weight Patients Undergoing Cesarean Delivery.

NCT01880112 | Withdrawn Phase 4

• 1 other identifier: H-23256
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Patients undergoing Cesarean delivery (C-Section) with a body mass index of 30 or less will be given either 2 grams or 4 grams of an antibiotic before surgery. The antibiotic is intended to prevent infection from the surgery. It is unknown what the best dose for the usual medicine used for this purpose (an antibiotic medicine called cefazolin). Samples of the tissue just under the skin will be biopsied at the time the incision is made and at the time the cut is stitched or stapled closed. A sample of the muscle of the womb will be taken as the womb is stitched closed after the delivery. Blood tests will be done at the start and end of surgery to test the antibiotic level. A blood sample will be taken from the umbilical cord after the baby has been delivered and the umbilical cord has been cut. The umbilical cord blood sample will be tested for the antibiotic level. These tests will be used to find out if the usual dose of medicine is enough or if more medicine is needed to prevent infection in normal weight women undergoing c-sections.

Conditions

Infection; Cesarean Delivery; Antibiotic Prophylaxis

Keywords

Infection; Cesarean delivery; Antibiotic prophylaxis; Cefazolin dosing

Outcome Measures

Primary Outcomes (1)

• Cefazolin drug level.

  Measurement of the serum and tissue level of cefazolin.

  Tissue and blood samples will be drawn during the surgical case only. Duration expected to be less than 120 minutes.

Study Arms (2)

4 gram dose

EXPERIMENTAL

Pre-operative prophylactic dose of 4 grams of cefazolin

Drug: Cefazolin

2 gram dose

ACTIVE COMPARATOR

Pre-operative prophylactic dose of 2 grams of cefazolin

Drug: Cefazolin

Interventions

Cefazolin DRUG

Cefazolin will be administered as pre-operative prophylaxis in normal weight patients undergoing Cesarean delivery. Tissue and serum levels will be measured at the time of the incision and when the incision is closed.

Also known as: Ancef

2 gram dose; 4 gram dose

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or above
• Body mass index (BMI) of 30 or less, as calculated from the height and weight at the first prenatal visit
• Undergoing cesarean delivery

You may not qualify if:

• BMI greater than 30.
• Not undergoing Cesarean delivery.
• Age less than 18 years.
• Pre-existing infection.
• Allergy to cephalosporin medications or a history of an anaphylactic reaction to penicillin.
• Cesarean delivery being performed under emergent circumstances

Sponsors & Collaborators

• West Virginia University: lead

Study Sites (1)

West Virginia University Hospital

Morgantown, West Virginia, 26506, United States

Location

MeSH Terms

Conditions

Infections

Interventions

Cefazolin

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• William H Holls, MD

  West Virginia University

  PRINCIPAL INVESTIGATOR

• Michael L Stitely, MD

  West Virginia University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Associate Professor

Study Record Dates

• First Submitted: June 29, 2011
• First Posted: June 18, 2013
• Study Start: June 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: June 18, 2013

Record last verified: 2013-06

Locations

US (1)