Infection Prevention Clinical Trial
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.
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.
Status | Completed |
Enrollment | 58 |
Est. completion date | July 2014 |
Est. primary completion date | July 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Women & Infants Hospital | Providence | Rhode Island |
Lead Sponsor | Collaborator |
---|---|
Women and Infants Hospital of Rhode Island |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Infectious morbidity | While in the hospital, chart reviews of the subject will be performed to identify any infectious complications. A follow-up telephone survey will be conducted to assess for this outcome as well at six to eight weeks after surgery. | Participants will be followed for a duration of 6-8 weeks after the cesarean section | No |
Primary | 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. | At the start of the cesarean section and at the end of the cesarean section | No |
Secondary | 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. | After antibiotic infusion, at the start of the cesarean section, and at the end of the cesarean section | No |
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---|---|---|---|
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