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Serum and Tissue Cefazolin Concentrations in Patients Undergoing Cesarean Delivery

NCT ID: NCT01755026

Last Updated: 2013-08-21

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2012-11-30

Brief Summary

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Patients undergoing Cesarean delivery (C-Section) with a body mass index of 35 or greater (this BMI number is in the obese range) 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 large women is 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 large women undergoing c-sections.

Detailed Description

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Conditions

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Cesarean Delivery Wound Infection Obesity

Keywords

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Cesarean Delivery Wound infection Obesity Prophylactic antibiotics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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2 gram dose of cefazolin

2 gram dose of pre-operative cefazolin

Group Type ACTIVE_COMPARATOR

cefazolin

Intervention Type DRUG

2 gram dose for pre-operative prophylaxis

4 gram Dose

4 gram dose of pre-operative prophylaxis

Group Type EXPERIMENTAL

cefazolin

Intervention Type DRUG

4 gram dose for pre-operative prophylaxis

Interventions

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cefazolin

2 gram dose for pre-operative prophylaxis

Intervention Type DRUG

cefazolin

4 gram dose for pre-operative prophylaxis

Intervention Type DRUG

Other Intervention Names

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Ancef Ancef

Eligibility Criteria

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Inclusion Criteria

1. Age 18 years or above
2. Body mass index (BMI) of 35 or greater at the time of the first obstetric clinic visit
3. Undergoing cesarean delivery

Exclusion Criteria

1. BMI less than 35.
2. Not undergoing Cesarean delivery.
3. Age less than 18 years.
4. Pre-existing infection.
5. Allergy to cephalosporin medications or a history of an anaphylactic reaction to penicillin.
6. Cesarean delivery being performed under emergent circumstances.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Michael Stitely

OTHER

Sponsor Role lead

Responsible Party

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Michael Stitely

Adjunct Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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William H Holls, MD

Role: PRINCIPAL_INVESTIGATOR

West Virginia University

Michael L Stitely, MD

Role: STUDY_CHAIR

West Virginia University

Locations

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West Virginia University Hospital

Morgantown, West Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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H-22512

Identifier Type: -

Identifier Source: org_study_id