Clinical trial NCT02838940: Preventive Antibiotic Serum Levels During Caesarean Section
Official title: Preventive Antibiotic Serum Levels During Caesarean Section
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Blood Antibiotic Levels
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-07-20
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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?

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Gestational age of 37 weeks and above.
2. Women who arrive to elective cesareans.
3. Age of women: 18-50 years old.

Exclusion Criteria:

1. Suspected clinical / laboratory active infection
2. urgent surgery
3. Sensitivity to penicillin or cephalosporins antibiotics that requires antibiotics change.
4. Women who received the week before surgery antibiotic treatment

Primary outcomes:
measure: Blood antibiotic levels
timeFrame: 30 min- 2 hours.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Tel Aviv Medical Center
name: Yariv Yogev, professor
role: PRINCIPAL_INVESTIGATOR
References: