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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: Completed Phase 4 study of Obesity and Cesarean Delivery, sponsored by Michael Stitely.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Cefazolin levels
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 |
What the finished NCT01755026 record still lists
NCT01755026 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (97% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Obesity
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01755026's enrollment target sits among peer trials
23 928th of 1053 higher than 120 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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