Preventive Antibiotic Serum Levels During Caesarean Section

NCT02838940 | Unknown Phase 3 DMC

• 1 other identifier: 0147-16-TLV
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

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. 1.What are the factors affecting the level of drug in the blood?
2. 2.Is there a fixed time which beyond it, blood drug levels are below the MIC(Minimal Inhibitory Concentration)?
3. 3.Is the provision of usual preventive care also addresses the situations of metabolic disorder?

Conditions

Blood Antibiotic Levels

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

cesarean in different indications

EXPERIMENTAL

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

Procedure: Blood samples.; Drug: Cefazolin

Interventions

Blood samples. 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.

cesarean in different indications

Cefazolin 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.

cesarean in different indications

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

MeSH Terms

Interventions

Blood Specimen Collection; Cefazolin

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Yariv Yogev, professor

  Tel Aviv Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yariv Yogev, professor

CONTACT

052-7360616; yarivy@tlvmc.gov.il

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2016
• First Posted: July 20, 2016
• Study Start: August 1, 2016
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: July 20, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share