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?

Study Overview

• Status: Unknown
• Conditions: Blood Antibiotic Levels
• Intervention / Treatment: Procedure: Blood samples.; Drug: Cefazolin

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.

• Study Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Procedure: 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.; Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood antibiotic levels	Blood MIC(Minimal Inhibitory Concentration) levels of antibiotic will be checked at first incision and at the time of closing surgery.	30 min- 2 hours.

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Anticipated): August 1, 2019
• Study Completion (Anticipated): August 1, 2019

Study Registration Dates

• First Submitted: May 29, 2016
• First Submitted That Met QC Criteria: July 17, 2016
• First Posted (Estimate): July 20, 2016

Study Record Updates

• Last Update Posted (Estimate): July 20, 2016
• Last Update Submitted That Met QC Criteria: July 17, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Bacterial Agents; Cefazolin
• Other Study ID Numbers: 0147-16-TLV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No