ObesityPhase 4NCT02049944
Increased Cefazolin During Cesarean Delivery in Obese Population
A Phase 4 study testing Cefazolin in people with Obesity and Obesity, Morbid, run by MemorialCare Health System at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Obesity, Obesity, Morbid, Pregnancy
- What is being tested?
- Cefazolin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2013to Dec 2014
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients at term (>37 weeks) undergoing a cesarean delivery at Women's Pavilion at Miller Children's Hospital and University of California, Irvine.
Who cannot join
- pre-gestational diabetes
- chronic hypertension
- collagen vascular disease
- renal impairment
- multiple gestation
- contraindications to Cefazolin administration (known anaphylactic reaction to penicillin's or known cephalosporin allergy)
- any exposure to cephalosporins in one week prior to cesarean section
- need for emergent cesarean delivery or diagnosis of chorioamnionitis
Trial locations and contacts
2 sites in 1 country.
United States2 sites
MemorialCare Center for Women at Miller Children's Hospital Long Beach and Long Beach Memorial Medical Center
Long Beach, California, 90806
University of California, Irvine
Orange, California, 92868
About this study
Official title: Increased Cefazolin (Ancef) Dosing for Prophylaxis During Cesarean Delivery in the 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 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.
Read the detailed description
Study Design:
This is a follow-up to the original pilot study (HS# 2009-7015 at UCI/587-08 at LBMMC). This study is also designed to be a prospective, non-randomized, non-blinded trial of the effects of obesity on adequacy of antimicrobial (cefazolin) concentrations with increased doses (from 2 grams to 3 grams) of preoperative prophylactic antibiotics within adipose tissues at the time of cesarean delivery.
Inclusion Criteria:
- Patients at term (>37 weeks) undergoing a cesarean delivery at LBMMC and UCI.
Exclusion criteria:
- pre-gestational diabetes
- chronic hypertension
- collagen vascular disease
- renal impairment
- multiple gestation
- contraindications to cefazolin administration (known anaphylactic reaction to penicillin's or known cephalosporin allergy)
- any exposure to cephalosporins in one week prior to cesarean section
- need for emergent cesarean delivery or diagnosis of chorioamnionitis
Study Procedure:
All patients requiring cesarean delivery under non-emergent circumstances, as determined by their physician, will be approached for participation in study by co-investigators. They will be approached on Labor and Delivery during their intake evaluation on the day of their scheduled procedure. Based on published literature and preliminary power analysis we expect that each of the 2 study groups will need 1414 subjects to demonstrate statistically significant difference in antibiotic concentrations within adipose tissue. The two groups will consist of:
- OBESE GROUP (BMI 30-40)
- MORBIDLY OBESE GROUP (BMI >40)
- All subjects will receive cefazolin at least 30, but no more than 60 minutes prior to skin incision.
- At the time of cesarean delivery, the following tissue samples will be collected:
- adipose tissue immediately following skin incision (prior to incision of the fascia) and
- adipose tissue prior to skin closure
- serum sample after skin incision but prior to completion of the operative procedure
Approximately 2 grams of tissue sampled from each site and 5 cc of blood will be required for analysis.
All samples will be collected by Dr. Swank, Dr. Wing or a physician who had previously been proctored in the proper tissue collecting techniques by either of the above mentioned investigators. Upon collection, tissue specimens will be blotted to remove residual blood and debris, weighed, and placed in a freezer (-80'C) until analysis. Serum samples will be drawn into red top tubes and immediately placed on wet ice. Immediately following completion of the surgery, they will then be centrifuged for 10 minutes at 3G (3200 rpm) and placed in a locked -80'C freezer until analysis.
Tissue and serum samples will then be sent to David P. Nicolau, PhD, FCCP, FIDSA, at the Center for Anti-Infective Research and Development, Hartford Hospital, Hartford, Connecticut. Samples will be batched and sent all together at the completion of study enrollment. Dr. Swank and the study nurse will be responsible for securely packing samples on dry ice and overnight shipping them to Dr. Nicolau. Once with Dr. Nicolau, the tissue samples will be homogenized and analyzed to determine zones of inhibition. The Cefazolin concentrations will be determined in the serum samples using a previously validated high-performance liquid chromatography method. 16 Tissues and serum will be sent without direct identifiers. Dr. Nicolau will not have access to the identity of the research subjects providing the samples.
- Conditions
- Obesity, Obesity, Morbid, Pregnancy, Infection; Cesarean Section
- Being tested
- Cefazolin
- Keywords
- Antibiotic Prophylaxis, Obesity, Obesity, Morbid, Pregnancy, Infection; Cesarean Section
- Medical subject headings
- Obesity, Obesity, Morbid, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CefazolinDrug
Also called Ancef
Participants who are undergoing an elective cesarean section at term will receive 3 grams of Cefazolin at least 30, but no more than 60 minutes prior to skin incision administered through an intravenous line.
| Study group | Role | What they receive |
|---|---|---|
| Cefazolin | Experimental | All subjects undergoing elective term cesarean delivery will receive 3 grams of Cefazolin at least 30, but no more than 60 minutes prior to skin incision. Receives: Drug: Cefazolin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achievement of Minimal Inhibitory Concentrations Within Adipose and Serum Sampled at Time of Cesarean Delivery
Primary Objective:
To assess the effects of increased prophylactic doses of Cefazolin in the obese and morbidly obese populations undergoing cesarean delivery. Effects will be defined as the ability to reach the minimal inhibitory concentrations for gram-positive and gram-negative organisms in adipose tissue and serum at time of skin incision and skin closure as defined by the Clinical and Laboratory Standards Institute
Measured: Each participant is to be observed per routine operative and post-operative guidelines, inpatient for 3-4 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2014 (estimated)
- Study startAug 2013
- Primary completionSep 2014
- Study completionDec 2014
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 ObesityStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- MemorialCare Health System
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Irvine
- Responsible party
- Sponsor
- Investigators
- Jennifer McNulty, MD, Principal investigator, MemorialCare Center for Women at Miller Children's Hospital Long Beach and Long Beach Memorial Medical CenterDeborah A Wing, MD, Principal investigator, University of California, IrvineMorgan Swank, MD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02049944
- Sponsor's protocol ID
- 186-13
- Status last verified
- Dec 2020
- First submitted
- 24 Jan 2014
- Last updated
- 2 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increased Cefazolin (Ancef) Dosing for Prophylaxis During Cesarean Delivery in the Obese Population
- ClinicalTrials.gov ID
- NCT02049944
- Acronym / sponsor ID
- 186-13
- Conditions
- Obesity, Obesity, Morbid, Pregnancy, Infection; Cesarean Section
- Keywords
- Antibiotic Prophylaxis, Obesity, Obesity, Morbid, Pregnancy, Infection; Cesarean Section
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- MemorialCare Health SystemUniversity, hospital or other
- Collaborators
- University of California, Irvine
- Study start
- Aug 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 30 Jan 2014 (estimated)
- Results
- Posted 2 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Design:
This is a follow-up to the original pilot study (HS# 2009-7015 at UCI/587-08 at LBMMC). This study is also designed to be a prospective, non-randomized, non-blinded trial of the effects of obesity on adequacy of antimicrobial (cefazolin) concentrations with increased doses (from 2 grams to 3 grams) of preoperative prophylactic antibiotics within adipose tissues at the time of cesarean delivery.
Inclusion Criteria:
- Patients at term (>37 weeks) undergoing a cesarean delivery at LBMMC and UCI.
Exclusion criteria:
- pre-gestational diabetes
- chronic hypertension
- collagen vascular disease
- renal impairment
- multiple gestation
- contraindications to cefazolin administration (known anaphylactic reaction to penicillin's or known cephalosporin allergy)
- any exposure to cephalosporins in one week prior to cesarean section
- need for emergent cesarean delivery or diagnosis of chorioamnionitis
Study Procedure:
All patients requiring cesarean delivery under non-emergent circumstances, as determined by their physician, will be approached for participation in study by co-investigators. They will be approached on Labor and Delivery during their intake evaluation on the day of their scheduled procedure. Based on published literature and preliminary power analysis we expect that each of the 2 study groups will need 1414 subjects to demonstrate statistically significant difference in antibiotic concentrations within adipose tissue. The two groups will consist of:
- OBESE GROUP (BMI 30-40)
- MORBIDLY OBESE GROUP (BMI >40)
- All subjects will receive cefazolin at least 30, but no more than 60 minutes prior to skin incision.
- At the time of cesarean delivery, the following tissue samples will be collected:
- adipose tissue immediately following skin incision (prior to incision of the fascia) and
- adipose tissue prior to skin closure
- serum sample after skin incision but prior to completion of the operative procedure
Approximately 2 grams of tissue sampled from each site and 5 cc of blood will be required for analysis.
All samples will be collected by Dr. Swank, Dr. Wing or a physician who had previously been proctored in the proper tissue collecting techniques by either of the above mentioned investigators. Upon collection, tissue specimens will be blotted to remove residual blood and debris, weighed, and placed in a freezer (-80'C) until analysis. Serum samples will be drawn into red top tubes and immediately placed on wet ice. Immediately following completion of the surgery, they will then be centrifuged for 10 minutes at 3G (3200 rpm) and placed in a locked -80'C freezer until analysis.
Tissue and serum samples will then be sent to David P. Nicolau, PhD, FCCP, FIDSA, at the Center for Anti-Infective Research and Development, Hartford Hospital, Hartford, Connecticut. Samples will be batched and sent all together at the completion of study enrollment. Dr. Swank and the study nurse will be responsible for securely packing samples on dry ice and overnight shipping them to Dr. Nicolau. Once with Dr. Nicolau, the tissue samples will be homogenized and analyzed to determine zones of inhibition. The Cefazolin concentrations will be determined in the serum samples using a previously validated high-performance liquid chromatography method. 16 Tissues and serum will be sent without direct identifiers. Dr. Nicolau will not have access to the identity of the research subjects providing the samples.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cefazolin | Experimental | Drug: CefazolinAll subjects undergoing elective term cesarean delivery will receive 3 grams of Cefazolin at least 30, but no more than 60 minutes prior to skin incision. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients at term (>37 weeks) undergoing a cesarean delivery at Women's Pavilion at Miller Children's Hospital and University of California, Irvine.
Key exclusion criteria (8 listed)
- pre-gestational diabetes
- chronic hypertension
- collagen vascular disease
- renal impairment
- multiple gestation
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: AncefParticipants who are undergoing an elective cesarean section at term will receive 3 grams of Cefazolin at least 30, but no more than 60 minutes prior to skin incision administered through an intravenous line. | Drug | Cefazolin |
Primary outcome
Achievement of Minimal Inhibitory Concentrations Within Adipose and Serum Sampled at Time of Cesarean Delivery
Time frame: Each participant is to be observed per routine operative and post-operative guidelines, inpatient for 3-4 days.
Primary Objective: To assess the effects of increased prophylactic doses of Cefazolin in the obese and morbidly obese populations undergoing cesarean delivery. Effects will be defined as the ability to reach the minimal inhibitory concentrations for gram-positive and gram-negative organisms in adipose tissue and serum at time of skin incision and skin closure as defined by the Clinical and Laboratory Standards Institute
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- 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.
Jennifer McNulty, MD principal investigator
MemorialCare Center for Women at Miller Children's Hospital Long Beach and Long Beach Memorial Medical Center
Deborah A Wing, MD principal investigator
University of California, Irvine
Morgan Swank, MD principal investigator
University of California, Irvine
2 sites 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 Obesity and Obesity, Morbid, run by MemorialCare Health System at 2 sites 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 1 inclusion and 8 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 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 2 Feb 2021). 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?
Achievement of Minimal Inhibitory Concentrations Within Adipose and Serum Sampled at Time of Cesarean Delivery (time frame: Each participant is to be observed per routine operative and post-operative guidelines, inpatient for 3-4 days.). 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 2 Feb 2021.