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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02473978

Enrollment

Registered

2015-06-17

Start date

2015-04-30

Completion date

2016-04-30

Last updated

2016-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anoxia

Keywords

During Labor, Complicating Anesthesia or Other Sedation, Cerebral

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.

Interventions

DEVICEINVOS Cerebral Oximetry

Participants will be connected to INVOS Cerebral Oximetry Cerebral Oximetry preoperativly and intraoperativly to ascess there cerebral perfusion throughout cesarean sections.

Study design

Observational model

CASE_CROSSOVER

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
measure the cerebral perfusion in participants undergoing cesarean sections deliveries, under spinal anesthesia, epidural anesthesia, and general anesthesia	The average time frame is 24 hours.

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026