Infection PreventionNCT01810354
PROPHYLACTIC ANTIBIOTICS PRIOR TO CESAREAN SECTION IN OBESE WOMEN
A study testing Cefazolin in people with Infection Prevention, run by Women and Infants Hospital of Rhode Island at 1 site in United States.
Trial summary
Surgical site infections are common and a cause of major morbidity. They are also more common in obese women. Cesarean sections are the most common surgery performed in the United States, therefore pregnant women are being faced with this problem frequently. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infection Prevention
- 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
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Jul 2014
- Phase
- Interventional
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Obese - body mass index (BMI) calculated as weight (kg)/ [height (m2)]greater than or equal to 30 as determined at their first prenatal visit
- Gestational age of 37 0/7 weeks and greater
- Singleton Pregnancy
- Non-emergent cesarean section
Who cannot join
- Known cephalosporin allergy
- Severe allergy to penicillin making cephalosporin use a contraindication
- Exposure to antibiotics in the preceding 7 days
- Need for emergent cesarean section
- Multiple gestations
- Suspected chorioamnionitis
- Pre-gestational diabetes
- Chronic hypertension with evidence of end organ damage
Trial locations and contacts
1 site in 1 country.
United States1 site
Women & Infants Hospital
Providence, Rhode Island, 02905
About this study
Official title: PROPHYLACTIC ANTIBIOTICS PRIOR TO CESAREAN SECTION IN OBESE WOMEN: Does Increasing the Dose Increase the Tissue Concentration?
Surgical site infections are common and a cause of major morbidity. They are also more common in obese women. Cesarean sections are the most common surgery performed in the United States, therefore pregnant women are being faced with this problem frequently. There is evidence to show that prophylactically administered antibiotics, cefazolin specifically, to obese women prior to cesarean section do not reach adequate concentrations in adipose tissue to prevent infection. The purpose of this study is to evaluate if an increased dose of cefazolin will attain adequate tissue concentration in obese women. Our hypothesis is that three grams of cefazolin given no more than 60 minutes prior to the start of a cesarean section in an obese (Body mass index (BMI) greater than or equal to 30) woman will attain adequate adipose tissue concentration compared to two grams of cefazolin.
Subjects will be selected if they are greater than 37 weeks gestation wiht a singleton pregnancy and require a cesarean section for any obstetrical indication. Women will be excluded if they have a suspected infection, have a multiple gestation, or have preexisting diabetes or hypertension with end organ damage. The subjects will be screened both by through the OR schedule as well as through the clinics. They will then be consented and enrolled by the primary investigator. Once enrolled the subjects will be randomized to receive either two grams or three grams of cefazolin as prophylactic antibiotics to be given no more than 60 minutes prior to the start of the surgery.
Read more
Two adipose tissue samples will be obtained at the time of surgery. The first at the start after skin incision and the second at the end prior to closure of the skin. There will also be a separate IV placed at the start of the procedure from which three blood draws can be collected. These three samples will be obtained at the start of the surgery but after antibiotic administration, at the time of the first adipose collection, and at the time of the second adipose collection. The samples will then be stored at -80 degrees and shipped to David P. Nicolau's lab in Hartford, CT for the tissue and serum analysis.
While the subjects are in the hospital recovering from their surgery, a chart review will be performed to determine if there are any infections occuring post-operatively. A telephone survey will be conducted six to eight weeks postpartum again assessing for any infectious complications after the cesarean section.
- Conditions
- Infection Prevention
- Being tested
- Cefazolin
- Keywords
- Cefazolin, Tissue concentration, infection, cesarean section, obese
- Medical subject headings
- Infections, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CefazolinDrug
| Study group | Role | What they receive |
|---|---|---|
| Two grams cefazolin | Experimental | Two grams of cefazolin will be given by intravenous bolus zero to 60 minutes prior to the start of the cesarean section. Receives: Drug: Cefazolin |
| Three grams cefazolin | Active comparator | Three grams of cefazolin will be given by intravenous bolus zero to 60 minutes prior to the start of the cesarean section. Receives: Drug: Cefazolin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adipose tissue concentration of cefazolin
Two separate two gram samples of adipose tissue will be removed from the subcutaneous tissue. The first sample will be removed after skin incision, yet prior to fascial incision. The second sample will be collected after fascial closure, yet prior to skin closure.
Measured: At the start of the cesarean section and at the end of the cesarean section
Secondary outcomes (1)
Serum cefazolin concentrations
Three separate intraoperative blood samples will be collected to evaluate the serum cefazolin concentrations. The first sample will be collected after antibiotic administration, prior to the surgery start. The next two samples will be collected coincidental to the time of adipose tissue collection. The first after skin incision, yet prior to fascial incision. The second after fascial closure, yet prior to skin closure.
Measured: After antibiotic infusion, at the start of the cesarean section, and at the end of the cesarean section
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2013 (estimated)
- Study startApr 2013
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infection PreventionStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Women and Infants Hospital of Rhode Island
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lindsay Maggio,, Women and Infants Hospital of Rhode Island
- Investigators
- Lindsay Maggio, MD, Principal investigator, Women & Infant's HospitalBrenna Anderson, MD, Study director, Women & Infants Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01810354
- Sponsor's protocol ID
- 13-0004
- Status last verified
- Jul 2014
- First submitted
- 7 Mar 2013
- Last updated
- 24 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Maggio L, Nicolau DP, DaCosta M, Rouse DJ, Hughes BL. Cefazolin prophylaxis in obese women undergoing cesarean delivery: a randomized controlled trial. Obstet Gynecol. 2015 May;125(5):1205-1210. doi: 10.1097/AOG.0000000000000789.
PubMed 25932849
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROPHYLACTIC ANTIBIOTICS PRIOR TO CESAREAN SECTION IN OBESE WOMEN: Does Increasing the Dose Increase the Tissue Concentration?
- ClinicalTrials.gov ID
- NCT01810354
- Acronym / sponsor ID
- 13-0004
- Conditions
- Infection Prevention
- Keywords
- Cefazolin, Tissue concentration, infection, cesarean section, obese
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Women and Infants Hospital of Rhode IslandUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 13 Mar 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.
Surgical site infections are common and a cause of major morbidity. They are also more common in obese women. Cesarean sections are the most common surgery performed in the United States, therefore pregnant women are being faced with this problem frequently. There is evidence to show that prophylactically administered antibiotics, cefazolin specifically, to obese women prior to cesarean section do not reach adequate concentrations in adipose tissue to prevent infection. The purpose of this study is to evaluate if an increased dose of cefazolin will attain adequate tissue concentration in obese women. Our hypothesis is that three grams of cefazolin given no more than 60 minutes prior to the start of a cesarean section in an obese (Body mass index (BMI) greater than or equal to 30) woman will attain adequate adipose tissue concentration compared to two grams of cefazolin.
Subjects will be selected if they are greater than 37 weeks gestation wiht a singleton pregnancy and require a cesarean section for any obstetrical indication. Women will be excluded if they have a suspected infection, have a multiple gestation, or have preexisting diabetes or hypertension with end organ damage. The subjects will be screened both by through the OR schedule as well as through the clinics. They will then be consented and enrolled by the primary investigator. Once enrolled the subjects will be randomized to receive either two grams or three grams of cefazolin as prophylactic antibiotics to be given no more than 60 minutes prior to the start of the surgery.
Two adipose tissue samples will be obtained at the time of surgery. The first at the start after skin incision and the second at the end prior to closure of the skin. There will also be a separate IV placed at the start of the procedure from which three blood draws can be collected. These three samples will be obtained at the start of the surgery but after antibiotic administration, at the time of the first adipose collection, and at the time of the second adipose collection. The samples will then be stored at -80 degrees and shipped to David P. Nicolau's lab in Hartford, CT for the tissue and serum analysis.
While the subjects are in the hospital recovering from their surgery, a chart review will be performed to determine if there are any infections occuring post-operatively. A telephone survey will be conducted six to eight weeks postpartum again assessing for any infectious complications after the cesarean section.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Two grams cefazolin | Experimental | Drug: CefazolinTwo grams of cefazolin will be given by intravenous bolus zero to 60 minutes prior to the start of the cesarean section. |
| Three grams cefazolin | Active comparator | Drug: CefazolinThree grams of cefazolin will be given by intravenous bolus zero to 60 minutes prior to the start of the cesarean section. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Obese - body mass index (BMI) calculated as weight (kg)/ [height (m2)]greater than or equal to 30 as determined at their first prenatal visit
- Gestational age of 37 0/7 weeks and greater
- Singleton Pregnancy
- Non-emergent cesarean section
Key exclusion criteria (8 listed)
- Known cephalosporin allergy
- Severe allergy to penicillin making cephalosporin use a contraindication
- Exposure to antibiotics in the preceding 7 days
- Need for emergent cesarean section
- Multiple gestations
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 |
|---|---|---|
| Cefazolin | Drug | Three grams cefazolin, Two grams cefazolin |
Primary outcome
Adipose tissue concentration of cefazolin
Time frame: At the start of the cesarean section and at the end of the cesarean section
Two separate two gram samples of adipose tissue will be removed from the subcutaneous tissue. The first sample will be removed after skin incision, yet prior to fascial incision. The second sample will be collected after fascial closure, yet prior to skin closure.
1 secondary outcome
Serum cefazolin concentrations
Time frame: After antibiotic infusion, at the start of the cesarean section, and at the end of the cesarean section
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2014.
- Derived from this study: PubMed 25932849Maggio L, Nicolau DP, DaCosta M, Rouse DJ, Hughes BL. Cefazolin prophylaxis in obese women undergoing cesarean delivery: a randomized controlled trial. Obstet Gynecol. 2015 May;125(5):1205-1210. doi: 10.1097/AOG.0000000000000789.
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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.
Lindsay Maggio, MD principal investigator
Women & Infant's Hospital
Brenna Anderson, MD study director
Women & Infants Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cefazolin in people with Infection Prevention, run by Women and Infants Hospital of Rhode Island 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 4 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 24 Jul 2014. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adipose tissue concentration of cefazolin (time frame: At the start of the cesarean section and at the end of the cesarean section). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01810354, which also lists 1 linked publication.
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 24 Jul 2014.