Blood Antibiotic Levels Clinical Trial
Official title:
Preventive Antibiotic Serum Levels During Caesarean Section
Background
Preventive antibiotic treatment before performing invasive procedures is a basic element in
preventing infections. The essence of preventive antibiotic treatment is strengthening the
defense mechanisms of the immune system by preserving a certain drug levels in the blood.
The timing of giving the antibiotics is very important. Several research groups have tried
to check the levels of Cefazolin (the most common antibiotics in the field of obstetrics) in
serum and adipose tissue in women during cesarean. These groups presented conflicting
research results.
OBJECTIVE
This study will discuss the preventive antibiotic treatment levels accepted prior cesareans,
to determine:
1. What are the factors affecting the level of drug in the blood?
2. Is there a fixed time which beyond it, blood drug levels are below the MIC(Minimal
Inhibitory Concentration)?
3. Is the provision of usual preventive care also addresses the situations of metabolic
disorder?
Background
Preventive antibiotic treatment before performing invasive procedures is a basic element in
preventing infections. The essence of preventive antibiotic treatment is strengthening the
defense mechanisms of the immune system by preserving a certain drug levels in the blood.
The timing of giving the antibiotics is very important. Several research groups have tried
to check the levels of Cefazolin (the most common antibiotics in the field of obstetrics) in
serum and adipose tissue in women during cesarean. These groups presented conflicting
research results.
OBJECTIVE
This study will discuss the preventive antibiotic treatment levels accepted prior cesareans,
to determine:
1. What are the factors affecting the level of drug in the blood?
2. Is there a fixed time which beyond it, blood drug levels are below the MIC(Minimal
Inhibitory Concentration)?
3. Is the provision of usual preventive care also addresses the situations of metabolic
disorder?
PATIENTS & METHODS
Women that meet the inclusion criteria and are about to undergo cesarean in different
indications, in elective and urgent way.
1. Before performing TIMEOUT outside the surgery room, The investigators will explanation
about the process and purpose of the study, and informed consent will be obtained.
2. Prior to the anesthesia by an anesthesiologist, the women will receive one dose of 1 g
Cefazolin the usual loading dose. Women with a BMI over 30 will receive Cefazolin of
about 2 grams.
3. With the beginning of the first incision in the skin, first blood sample will be taken
to test levels of antibiotics in serum.
4. Second blood sample to test drug levels in serum will be taken while closing the
surgical incision in the skin at the end of the operation.
5. The continuation of post surgery recovery process will be as usual, in accordance with
departmental protocols.
With the results of tissue and serum samples, segmentation which compares the drug levels in
the different tissues will be performed.Also, the correlation between drug levels in women
with different BMI and morbidities that may cause measurable or not pharmacokinetic changes
will be examined.
;
Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention