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NCT02049944 · ClinicalTrials.gov registry record · Phase 4
Increased Cefazolin During Cesarean Delivery in Obese Population
A Phase 4 study, sponsored by MemorialCare Health System.
- Completed
- Registry status
- Phase 4
- Development phase
- 30
- Enrollment target
NCT02049944 is a Phase 4 study that has completed, run by MemorialCare Health System. The registered enrollment target is 30 participants.
The verdict
NCT02049944, a Phase 4 study, has completed, sponsored by MemorialCare Health System.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 30 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether an increased prophylactic dose (3 grams) of cefazolin at the time of cesarean delivery has superior coverage in adipose tissue than the current established dosing of 2 grams. The tissue and serum concentration values, when using an increased prophylactic dose, can then be compared to our pilot study assays in hopes of determining an optimal dosing for the obese and morbidly obese populations undergoing cesarean delivery. A previous study performed at University of California, Irvine (UCI) and Long Beach Memorial Medical Center/Miller Children's Hospital (LBMMC) showed that the standard dose of antibiotics (2 grams of cefazolin) did not provide adequate coverage for all organisms in the obese and extremely obese populations. The purpose of this research study is to evaluate whether in increased dose of antibiotics given before cesarean delivery (3 grams of cefazolin) will reach adequate levels in adipose (fat cells underneath the skin) and serum (blood) samples. In addition, researchers hope to evaluate if/how the mother's weight has an effect on the levels of antibiotics in the tissues (a group of similar cells). This follow up study (prior study HS# 2009-7015 at UCI) will enroll obese (Body Mass Index (BMI) of 30-40) and morbidly obese (BMI \>40) women to receive an increased dose of prophylactic cefazolin at time of scheduled cesarean delivery at both UCI and LBMMC. Researchers hope to enroll a total of 35 women overall.
Interventions
- DRUG Cefazolin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2013-08 |
| Est. Completion | 2014-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02049944
The ClinicalTrials.gov registry entry for NCT02049944 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is MemorialCare Health System, which has 21 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Cefazolin is the first listed.
NCT02049944 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02049944 about?
NCT02049944 is a clinical study titled "Increased Cefazolin During Cesarean Delivery in Obese Population". The purpose of this study is to determine whether an increased prophylactic dose (3 grams) of cefazolin at the time of cesarean delivery has superior coverage in adipose tissue than the current established dosing of 2 grams. The tissue and serum concentration values, when using an increased prophyla...
What is the current status of trial NCT02049944?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2013-08. Estimated completion is 2014-12.
What interventions are being tested in trial NCT02049944?
The interventions under investigation include: Cefazolin (DRUG).
Who is sponsoring clinical trial NCT02049944?
This trial is sponsored by MemorialCare Health System, which has 21 total clinical trials registered on ClinicalTrials.gov.
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