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Serum and Tissue Cefazolin Concentrations in Patients Undergoing Cesarean Delivery
NCT01755026 · View on ClinicalTrials.gov ↗
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
Interventions
- DRUG cefazolin
Study Locations (1)
West Virginia
- West Virginia University Hospital — Morgantown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2010-11 |
| Est. Completion | 2012-11 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01755026
The ClinicalTrials.gov registry entry for NCT01755026 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Michael Stitely, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01755026 reports 1 study location spanning 1 distinct geographic area — top geographies include West Virginia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01755026?
The interventions under investigation include: cefazolin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01755026?
This trial is sponsored by Michael Stitely, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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