InfectionPhase 4NCT01880112
Serum and Tissue Cefazolin Concentrations in Normal Weight Patients Undergoing Cesarean Delivery.
A Phase 4 study testing Cefazolin in people with Infection and Cesarean Delivery, run by West Virginia University at 1 site in United States.
Trial summary
Patients undergoing Cesarean delivery (C-Section) with a body mass index of 30 or less will be given either 2 grams or 4 grams of an antibiotic before surgery. The antibiotic is intended to prevent infection from the surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Infection, Cesarean Delivery, Antibiotic Prophylaxis
- What is being tested?
- Cefazolin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Jun 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or above
- Body mass index (BMI) of 30 or less, as calculated from the height and weight at the first prenatal visit
- Undergoing cesarean delivery
Who cannot join
- BMI greater than 30.
- Not undergoing Cesarean delivery.
- Age less than 18 years.
- Pre-existing infection.
- Allergy to cephalosporin medications or a history of an anaphylactic reaction to penicillin.
- Cesarean delivery being performed under emergent circumstances
Trial locations and contacts
1 site in 1 country.
United States1 site
West Virginia University Hospital
Morgantown, West Virginia, 26506
About this study
Official title: Serum and Tissue Cefazolin Concentrations in Normal Weight Patients Undergoing Cesarean Delivery Receiving Two Differing Doses of Pre-operative Cefazolin.
Patients undergoing Cesarean delivery (C-Section) with a body mass index of 30 or less 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 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 normal weight women undergoing c-sections.
- Conditions
- Infection, Cesarean Delivery, Antibiotic Prophylaxis
- Being tested
- Cefazolin
- Keywords
- Infection, Cesarean delivery, Antibiotic prophylaxis, Cefazolin dosing
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CefazolinDrug
Also called Ancef
Cefazolin will be administered as pre-operative prophylaxis in normal weight patients undergoing Cesarean delivery. Tissue and serum levels will be measured at the time of the incision and when the incision is closed.
| Study group | Role | What they receive |
|---|---|---|
| 4 gram dose | Experimental | Pre-operative prophylactic dose of 4 grams of cefazolin Receives: Drug: Cefazolin |
| 2 gram dose | Active comparator | Pre-operative prophylactic dose of 2 grams of cefazolin Receives: Drug: Cefazolin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cefazolin drug level.
Measurement of the serum and tissue level of cefazolin.
Measured: Tissue and blood samples will be drawn during the surgical case only. Duration expected to be less than 120 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2013 (estimated)
- Study startJun 2011
- Primary completionJun 2013
- Study completionJun 2013 (estimated)
Why it stopped: There is no longer need for this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Stitely, West Virginia University
- Investigators
- William H Holls, MD, Principal investigator, West Virginia UniversityMichael L Stitely, MD, Study chair, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01880112
- Sponsor's protocol ID
- H-23256
- Status last verified
- Jun 2013
- First submitted
- 29 Jun 2011
- Last updated
- 18 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum and Tissue Cefazolin Concentrations in Normal Weight Patients Undergoing Cesarean Delivery Receiving Two Differing Doses of Pre-operative Cefazolin.
- ClinicalTrials.gov ID
- NCT01880112
- Acronym / sponsor ID
- H-23256
- Conditions
- Infection, Cesarean Delivery, Antibiotic Prophylaxis
- Keywords
- Infection, Cesarean delivery, Antibiotic prophylaxis, Cefazolin dosing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: There is no longer need for this study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (estimated)
- First posted
- 18 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients undergoing Cesarean delivery (C-Section) with a body mass index of 30 or less 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 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 normal weight women undergoing c-sections.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4 gram dose | Experimental | Drug: CefazolinPre-operative prophylactic dose of 4 grams of cefazolin |
| 2 gram dose | Active comparator | Drug: CefazolinPre-operative prophylactic dose of 2 grams of cefazolin |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or above
- Body mass index (BMI) of 30 or less, as calculated from the height and weight at the first prenatal visit
- Undergoing cesarean delivery
Key exclusion criteria (6 listed)
- BMI greater than 30.
- Not undergoing Cesarean delivery.
- Age less than 18 years.
- Pre-existing infection.
- Allergy to cephalosporin medications or a history of an anaphylactic reaction to penicillin.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CefazolinAlso: AncefCefazolin will be administered as pre-operative prophylaxis in normal weight patients undergoing Cesarean delivery. Tissue and serum levels will be measured at the time of the incision and when the incision is closed. | Drug | 2 gram dose, 4 gram dose |
Primary outcome
Cefazolin drug level.
Time frame: Tissue and blood samples will be drawn during the surgical case only. Duration expected to be less than 120 minutes.
Measurement of the serum and tissue level of cefazolin.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2013.
Related trials for Infection
Active, not recruitingObservational study
Host Response to Infection and Treatment in Filarial Diseases
Filariasis, Helminthiasis
Active, not recruitingObservational study
Analysis of Coronavirus Disease 19 (COVID-19) Convalescent Plasma
Asymptomatic COVID-19 Infection Laboratory-Confirmed, Symptomatic COVID-19 Infection Laboratory-Confirmed
Active, not recruiting
Barrier-Protect Study
Infection
RecruitingPhase 3
Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen
Viral Lung Infection and Acute Respiratory Failure
RecruitingPhase 2
Evaluating the Safety and Immunogenicity of MTBVAC
HIV I Infection, Tuberculosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William H Holls, MD principal investigator
West Virginia University
Michael L Stitely, MD study chair
West Virginia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cefazolin in people with Infection and Cesarean Delivery, run by West Virginia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cefazolin drug level. (time frame: Tissue and blood samples will be drawn during the surgical case only. Duration expected to be less than 120 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2013; AzTrials last refreshed its copy on 1 Nov 2026.