Hemodynamic Monitoring in Women Throughout Cesarean Sections

March 27, 2019 updated by: Rabin Medical Center

Maternal Hemodynamic Monitoring in Women Undergoing Cesarean Section by Use of NICaS Cardiac Impedance

In this study we would like to monitor cardiac output by the use of NICAS bioimpedance 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. This study's primary objective is to evaluate how spinal and general anesthesia influences cardiac output during cesarean section deliveries. Secondary endpoints is whether the hemodynamic changes as measured in cardiac output correlate with women's pain, measured by a visual analogue scale(VAS) from o-10. (0=representing no pain at all, 10= worse pain imaginable)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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. Women will be recruited half an hour preoperatively in the women's surgery waiting room when they aren't experiencing any pain, and aren't under any sedatives.

Following obtaining an informed consent maternal cardiac output will be monitored.

The monitoring will be carried out using non invasive NICaS cardiac impedance by the use of two electrodes stickers which are pasted on the wrists for about 6 minutes.

Monitoring will be done with women lying down or sitting up half an hour preoperatively (in the woman's surgery waiting room) intraoperatively, and postoperatively in the post anesthesia care unit (PACU).

Preoperative data will be compared to intraoperative and postoperative data, and will be analyzed in order to evaluate the dynamic cardiac output changes in women undergoing cesarean sections.

Recorded data will include:

  • Demographic and obstetric - age, weight, height, current hemoglobin, co-morbidities, regular medication and other obstetric data.
  • Cardiovascular risk factors - a family history of cardiovascular disease, smoking, BMI
  • Obstetric history - obstetric background (history of gestational diabetes, preeclampsia, intrauterine growth restriction (IUGR), stillbirths or placental abruption).
  • Threshold of pain according to VAS It should be emphasized that the conduct of the study will not interfere in with cesarean delivery protocol in any way.

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Petach tikvah, Israel
        • Beilinson Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Healthy and hypertensive women above 18 undergoing cesarean section deliveries.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Parturients undergoing cesarean section
Healthy parturients, hypertensive parturients and parturients suffering from preeclampsia above 18 undergoing cesarean section deliveries .

Hemodynamic monitoring will be carried out using non invasive NICaS cardiac impedance by the use of two electrodes stickers which are pasted on the wrists for about 6 minutes.

Monitoring will be done with women lying down or sitting up half an hour preoperatively (in the woman's surgery waiting room) intraoperatively, and postoperatively in the PACU.

Preoperative data will be compared to intraoperative and postoperative data, and will be analyzed in order to evaluate the dynamic cardiac output changes in women undergoing cesarean sections.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemodynamic changes in cesarean section as measured by NICaS parameters.
Time Frame: A year
This study's primary objective is to evaluate how anesthesia influences cardiac output during cesarean section deliveries
A year

Secondary Outcome Measures

Outcome Measure
Time Frame
Hemodynamic changes measured by NICaS parameters and their correlation with pain in women undergoing cesarean sections as measured by VAS.
Time Frame: A year
A year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

June 1, 2016

First Submitted That Met QC Criteria

September 11, 2016

First Posted (Estimate)

September 15, 2016

Study Record Updates

Last Update Posted (Actual)

March 29, 2019

Last Update Submitted That Met QC Criteria

March 27, 2019

Last Verified

May 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 0512-15-RMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

In this study the investigators would like to monitor cardiac output by the use of NICaS bioimpedance 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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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