Cesarean DeliveryPhase 4NCT01755026
Serum and Tissue Cefazolin Concentrations in Patients Undergoing Cesarean Delivery
A Phase 4 study testing cefazolin in people with Cesarean Delivery and Wound Infection, run by Michael Stitely at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cesarean Delivery, Wound Infection, Obesity
- What is being tested?
- cefazolin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Nov 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 35 or greater at the time of the first obstetric clinic visit
- Undergoing cesarean delivery
Who cannot join
- BMI less than 35.
- 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 Patients Undergoing Cesarean Delivery Receiving Two Differing Doses of Pre-operative Cefazolin.
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
- Cesarean Delivery, Wound Infection, Obesity
- Being tested
- cefazolin
- Keywords
- Cesarean Delivery, Wound infection, Obesity, Prophylactic antibiotics
- Medical subject headings
- Wound Infection, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cefazolinDrug
Also called Ancef
2 gram dose for pre-operative prophylaxis
cefazolinDrug
Also called Ancef
4 gram dose for pre-operative prophylaxis
| Study group | Role | What they receive |
|---|---|---|
| 2 gram dose of cefazolin | Active comparator | 2 gram dose of pre-operative cefazolin Receives: Drug: cefazolin |
| 4 gram Dose | Experimental | 4 gram dose of pre-operative prophylaxis Receives: Drug: cefazolin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cefazolin Levels
Cefazolin levels
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2012 (estimated)
- Study startNov 2010
- Primary completionJul 2011
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cesarean DeliveryStudies 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael Stitely
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-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
- NCT01755026
- Sponsor's protocol ID
- H-22512
- Status last verified
- Jun 2013
- First submitted
- 29 Jun 2011
- Last updated
- 21 Aug 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum and Tissue Cefazolin Concentrations in Patients Undergoing Cesarean Delivery Receiving Two Differing Doses of Pre-operative Cefazolin.
- ClinicalTrials.gov ID
- NCT01755026
- Acronym / sponsor ID
- H-22512
- Conditions
- Cesarean Delivery, Wound Infection, Obesity
- Keywords
- Cesarean Delivery, Wound infection, Obesity, Prophylactic antibiotics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Michael StitelyUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 21 Dec 2012 (estimated)
- Results
- Posted 21 Aug 2013
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 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 gram dose of cefazolin | Active comparator | Drug: cefazolin2 gram dose of pre-operative cefazolin |
| 4 gram Dose | Experimental | Drug: cefazolin4 gram dose of pre-operative prophylaxis |
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 35 or greater at the time of the first obstetric clinic visit
- Undergoing cesarean delivery
Key exclusion criteria (6 listed)
- BMI less than 35.
- 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: Ancef2 gram dose for pre-operative prophylaxis | Drug | 2 gram dose of cefazolin |
| cefazolinAlso: Ancef4 gram dose for pre-operative prophylaxis | Drug | 4 gram Dose |
Primary outcome
Cefazolin Levels
Time frame: 2 hours
Cefazolin levels
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Cesarean Delivery and Wound Infection, run by Michael Stitely 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: finished, as of the sponsor's last update on 21 Aug 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?
Yes. Results are posted in the registry (first posted 21 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Levels (time frame: 2 hours). 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 21 Aug 2013.