Preventive Antibiotic Serum Levels During Caesarean Section

NCT ID: NCT02838940

Last Updated: 2016-07-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2019-08-31

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.

Conditions

Blood Antibiotic Levels

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

cesarean in different indications

Women that are about to undergo an elective cesarean in different indications.

Group Type: EXPERIMENTAL

Blood samples.

Intervention Type: PROCEDURE

At the beginning of the first incision in the skin, first blood sample will be taken for levels of antibiotics in serum test.

Second blood sample for drug levels in serum test, will be taken while closing the surgical incision in the skin at the end of the operation.

Cefazolin

Intervention Type: DRUG

According to the ward protocol 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.

Interventions

Blood samples.

At the beginning of the first incision in the skin, first blood sample will be taken for levels of antibiotics in serum test.

Second blood sample for drug levels in serum test, will be taken while closing the surgical incision in the skin at the end of the operation.

Intervention Type: PROCEDURE

Cefazolin

According to the ward protocol 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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yariv Yogev, professor

Role: PRINCIPAL_INVESTIGATOR

Tel Aviv Medical Center

Central Contacts

Yariv Yogev, professor

Role: CONTACT

yarivy@tlvmc.gov.il

052-7360616

Other Identifiers

0147-16-TLV

Identifier Type: -

Identifier Source: org_study_id