PROPHYLACTIC ANTIBIOTICS PRIOR TO CESAREAN SECTION IN OBESE WOMEN
Status:
Completed
Trial end date:
2014-07-01
Target enrollment:
Participant gender:
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. 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.