Cesarean Delivery, Obesity, Wound Infection
Conditions
Keywords
Cesarean Delivery, Wound infection, Obesity, Prophylactic antibiotics
Brief 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. 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.
Interventions
DRUGcefazolin
2 gram dose for pre-operative prophylaxis
Sponsors
Michael Stitely
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 years or above 2. Body mass index (BMI) of 35 or greater at the time of the first obstetric clinic visit 3. Undergoing cesarean delivery
Exclusion criteria
1. BMI less than 35. 2. Not undergoing Cesarean delivery. 3. Age less than 18 years. 4. Pre-existing infection. 5. Allergy to cephalosporin medications or a history of an anaphylactic reaction to penicillin. 6. Cesarean delivery being performed under emergent circumstances.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cefazolin Levels | 2 hours | Cefazolin levels |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 4 Gram Dose 4 gram dose of pre-operative prophylaxis | 11 |
| 2 Gram Dose of Cefazolin 2 gram dose of pre-operative cefazolin | 12 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | 2 Gram Dose of Cefazolin | 4 Gram Dose | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 11 Participants | 23 Participants |
| Age Continuous | 31.09 years STANDARD_DEVIATION 6.46 | 30.33 years STANDARD_DEVIATION 4.64 | 31 years STANDARD_DEVIATION 5 |
| Region of Enrollment United States | 12 participants | 11 participants | 23 participants |
| Sex: Female, Male Female | 12 Participants | 11 Participants | 23 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 11 | 0 / 12 |
| serious Total, serious adverse events | 0 / 11 | 0 / 12 |
Outcome results
Primary
Cefazolin Levels
Cefazolin levels
Time frame: 2 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 2 Gram Dose of Cefazolin | Cefazolin Levels | Subcutaneous tissue-opening | 18.36 mcg/mL | Standard Error 6.68 |
| 2 Gram Dose of Cefazolin | Cefazolin Levels | Subcutaneous tissue-closing | 21.73 mcg/mL | Standard Error 16.02 |
| 2 Gram Dose of Cefazolin | Cefazolin Levels | Plasma concentration at incision | 155.45 mcg/mL | Standard Error 50.97 |
| 2 Gram Dose of Cefazolin | Cefazolin Levels | Plasma concentration at closure | 83.49 mcg/mL | Standard Error 34.97 |
| 2 Gram Dose of Cefazolin | Cefazolin Levels | Myometrial levels | 67.18 mcg/mL | Standard Error 13.89 |
| 2 Gram Dose of Cefazolin | Cefazolin Levels | Umbilical cord blood concentrations | 25.01 mcg/mL | Standard Error 12.03 |
| 4 Gram Dose | Cefazolin Levels | Myometrial levels | 146.22 mcg/mL | Standard Error 60.99 |
| 4 Gram Dose | Cefazolin Levels | Subcutaneous tissue-opening | 40.11 mcg/mL | Standard Error 24.1 |
| 4 Gram Dose | Cefazolin Levels | Plasma concentration at closure | 150.12 mcg/mL | Standard Error 55.54 |
| 4 Gram Dose | Cefazolin Levels | Subcutaneous tissue-closing | 34.89 mcg/mL | Standard Error 17.42 |
| 4 Gram Dose | Cefazolin Levels | Umbilical cord blood concentrations | 82.23 mcg/mL | Standard Error 43.03 |
| 4 Gram Dose | Cefazolin Levels | Plasma concentration at incision | 346.16 mcg/mL | Standard Error 166.01 |
p-value: <0.01t-test, 2 sided