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Hemodynamic Monitoring in Women Throughout Cesarean Sections

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ClinicalTrials.gov Identifier: NCT02902068
Recruitment Status : Completed
First Posted : September 15, 2016
Last Update Posted : March 29, 2019
Sponsor:
Information provided by (Responsible Party):
Rabin Medical Center

Brief Summary:

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)


Condition or disease Intervention/treatment
Hemodynamics Device: NICaS Bio Impedance

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.

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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Maternal Hemodynamic Monitoring in Women Undergoing Cesarean Section by Use of NICaS Cardiac Impedance
Study Start Date : May 2016
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Group/Cohort Intervention/treatment
Parturients undergoing cesarean section
Healthy parturients, hypertensive parturients and parturients suffering from preeclampsia above 18 undergoing cesarean section deliveries .
Device: NICaS Bio Impedance

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.





Primary Outcome Measures :
  1. 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


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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy and hypertensive women above 18 undergoing cesarean section deliveries.
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02902068


Locations
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Israel
Beilinson hospital
Petach tikvah, Israel
Sponsors and Collaborators
Rabin Medical Center
Publications:

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Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT02902068    
Other Study ID Numbers: 0512-15-RMC
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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.