Clinical trial NCT02473978: Cerebral Near-infrared Spectroscopy (NIRS) Monitoring Throughout Caesarean Deliveries
Official title: Cerebral Near-infrared Spectroscopy (NIRS) Monitoring Throughout Caesarean Deliveries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anoxia
Keywords: During Labor
Complicating Anesthesia or Other Sedation
Cerebral
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2015-06-17
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All women undergoing cesarean section in Beilinson Hospital.

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.

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.

Primary outcomes:
measure: measure the cerebral perfusion in participants undergoing cesarean sections deliveries, under spinal anesthesia, epidural anesthesia, and general anesthesia
timeFrame: The average time frame is 24 hours.
Secondary outcomes:
Other outcomes:
Locations:
city: Petach tikvah
country: Israel
facility: Beilinson hospital
Study officials:
affiliation: Rabin Medical Center
name: sharon orbach, md
role: PRINCIPAL_INVESTIGATOR
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