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NCT01755026 · ClinicalTrials.gov registry record · Phase 4

Serum and Tissue Cefazolin Concentrations in Patients Undergoing Cesarean Delivery

A Phase 4 study of Obesity and Cesarean Delivery, sponsored by Michael Stitely.

Completed
Registry status
Phase 4
Development phase
23
Enrollment target
1
Study location

NCT01755026 is a Phase 4 study of Obesity and Cesarean Delivery that has completed, run by Michael Stitely. The registered enrollment target is 23 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01755026, a Phase 4 study of Obesity and Cesarean Delivery, has completed, sponsored by Michael Stitely.

COMPLETED
Registry status
Phase 4
Development phase
23 participants
Enrollment target
1
Study location

Study Summary

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.

Conditions Studied

Obesity Cesarean Delivery Wound Infection

Interventions

  • DRUG cefazolin

Study Locations (1)

West Virginia

  • West Virginia University Hospital - Morgantown

Trial Details

FieldValue
Enrollment Target 23 participants
Start Date 2010-11
Est. Completion 2012-11
Phase Phase 4

Sponsor

Michael Stitely

1 total trials

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What the Registry Record Tells You About NCT01755026

The ClinicalTrials.gov registry entry for NCT01755026 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (97% lower). The listed sponsor is Michael Stitely, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Obesity appearing as the primary indexed condition, and to 1 intervention - of which cefazolin is the first listed.

NCT01755026 reports 1 study location spanning 1 distinct geographic area - top geographies include West Virginia.

Frequently Asked Questions

What is clinical trial NCT01755026 about?

NCT01755026 is a clinical study titled "Serum and Tissue Cefazolin Concentrations in Patients Undergoing Cesarean Delivery". 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...

What is the current status of trial NCT01755026?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 23 participants. The study started on 2010-11. Estimated completion is 2012-11.

What conditions does trial NCT01755026 study?

This clinical trial studies the following conditions: Obesity, Cesarean Delivery, Wound Infection.

What interventions are being tested in trial NCT01755026?

The interventions under investigation include: cefazolin (DRUG).

Who is sponsoring clinical trial NCT01755026?

This trial is sponsored by Michael Stitely, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01755026 being conducted?

This trial has 1 study location across West Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.