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

Serum and Tissue Cefazolin Concentrations in Normal Weight Patients Undergoing Cesarean Delivery Receiving Two Differing Doses of Pre-operative Cefazolin.

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01880112

Enrollment

Registered

2013-06-18

Start date

2011-06-30

Completion date

2013-06-30

Last updated

2013-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antibiotic Prophylaxis, Cesarean Delivery, Infection

Keywords

Infection, Cesarean delivery, Antibiotic prophylaxis, Cefazolin dosing

Brief summary

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.

Interventions

DRUGCefazolin

Cefazolin will be administered as pre-operative prophylaxis in normal weight patients undergoing Cesarean delivery. Tissue and serum levels will be measured at the time of the incision and when the incision is closed.

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

Inclusion criteria

1. Age 18 years or above 2. Body mass index (BMI) of 30 or less, as calculated from the height and weight at the first prenatal visit 3. Undergoing cesarean delivery

Exclusion criteria

1. BMI greater than 30. 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 drug level.	Tissue and blood samples will be drawn during the surgical case only. Duration expected to be less than 120 minutes.	Measurement of the serum and tissue level of cefazolin.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026