Serum and Tissue Cefazolin Concentrations in Normal Weight Patients Undergoing Cesarean Delivery.

West Virginia University

Status and phase

Withdrawn

Phase 4

Conditions

Infection

Cesarean Delivery

Antibiotic Prophylaxis

Treatments

Drug: Cefazolin

Study type

Interventional

Funder types

Other

Identifiers

NCT01880112

H-23256

Details and patient eligibility

About

Patients undergoing Cesarean delivery (C-Section) with a body mass index of 30 or less 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 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 normal weight women undergoing c-sections.

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age 18 years or above
Body mass index (BMI) of 30 or less, as calculated from the height and weight at the first prenatal visit
Undergoing cesarean delivery

Exclusion criteria

BMI greater than 30.
Not undergoing Cesarean delivery.
Age less than 18 years.
Pre-existing infection.
Allergy to cephalosporin medications or a history of an anaphylactic reaction to penicillin.
Cesarean delivery being performed under emergent circumstances