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Clinical Trials/NCT02473978
NCT02473978
Completed
N/A

Cerebral Near-infrared Spectroscopy (NIRS) Monitoring Throughout Caesarean Deliveries

Rabin Medical Center1 site in 1 country84 target enrollmentApril 2015
ConditionsAnoxia

Overview

Phase
N/A
Intervention
Not specified
Conditions
Anoxia
Sponsor
Rabin Medical Center
Enrollment
84
Locations
1
Primary Endpoint
measure the cerebral perfusion in participants undergoing cesarean sections deliveries, under spinal anesthesia, epidural anesthesia, and general anesthesia
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

In this study the investigator would like to examine hemodynamic cerebral blood flow and brain function by the use of Invos cerebral oximetry in women undergoing cesarean section delivery.

This study is a purely observational study, it will not have any clinical intervention nor will it interfere with standard cesarean delivery protocols in any way.

The investigator's primary objective is to evaluate how anesthesia influences cerebral blood flow perfusion during cesarean section deliveries.

Detailed Description

This is a prospective, single center study which will be conducted at the Rabin Medical Center (Beilinson Campus), Petach Tikva, Israel, a tertiary university hospital. The Institutional Review Board has approved this study. Two hundred women undergoing cesarean sections will be enrolled after filling out an informed consent form. Cerebral blood flow perfusion will be monitored preoperatively, intraoperativly and half an hour postoperativly, for all enrolled participants using INVOS Cerebral Oximetry. Preoperative data will be compared to intraoperative data and analyzed in order to evaluate the dynamic cerebral oxygen and blood perfusion changes in women undergoing cesarean sections.

Registry
clinicaltrials.gov
Start Date
April 2015
End Date
April 2016
Last Updated
9 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

sharonorbach

Doctor

Rabin Medical Center

Eligibility Criteria

Inclusion Criteria

  • All women undergoing cesarean section in Beilinson Hospital following obtaining written informed consents forums with the ability to comply to the study requirements will be included in our study.

Exclusion Criteria

  • Women under age 18 , and women who don't understand the inform consent form will be excluded from participating.

Outcomes

Primary Outcomes

measure the cerebral perfusion in participants undergoing cesarean sections deliveries, under spinal anesthesia, epidural anesthesia, and general anesthesia

Time Frame: The average time frame is 24 hours.

Study Sites (1)

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