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The Effects of Labor Stages and Interventions on Hemodynamic Measures During & After Childbirth With Noninvasive Sensors

Primary Purpose

Rupture of Membranes; Premature, Cesarean Section; Infection, Preeclampsia

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
biobeat sensor
Sponsored by
Hillel Yaffe Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Rupture of Membranes; Premature

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Pregnant woman between 18-45 years old
  • with non cardiovascular disease

Exclusion Criteria:

  • woman with a cardiovascular disease
  • woman who don't agree to participate in the trial

Sites / Locations

  • Hillel Yaffe Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

biobeat sensor

Arm Description

Outcomes

Primary Outcome Measures

biobeat sensor is a noninvasive sensor of the the hymodynamic measures during the childbirth
biobeat sensor is a noninvasive sensor of the the hymodynamic measures during the childbirth

Secondary Outcome Measures

biobeat sensor is a noninvasive sensor of the the hymodynamic measures after 24 hours of the childbirth
biobeat sensor is a noninvasive sensor of the the hymodynamic measures after 24 hours of the childbirth

Full Information

First Posted
January 30, 2019
Last Updated
June 22, 2022
Sponsor
Hillel Yaffe Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03838965
Brief Title
The Effects of Labor Stages and Interventions on Hemodynamic Measures During & After Childbirth With Noninvasive Sensors
Official Title
The Effects of Labor Stages and Interventions on Hemodynamic Measures During and After Childbirth (Epidural, Rupture of Membranes, Cesarean Sections and Preeclampsia) With Noninvasive Sensors.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
December 16, 2020 (Actual)
Study Completion Date
December 16, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hillel Yaffe Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The Effects of Labor Stages and Interventions on Hemodynamic Measures During and After Childbirth ( Epidural, Rupture Membranses Cesarean Sections and Preeclampsia) With Noninvasive Sensors.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rupture of Membranes; Premature, Cesarean Section; Infection, Preeclampsia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
biobeat sensor
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
biobeat sensor
Intervention Description
biobeat sensor is a noninvasive sensor of the the hymodynamic measures during the childbirth and after 24 hours.
Primary Outcome Measure Information:
Title
biobeat sensor is a noninvasive sensor of the the hymodynamic measures during the childbirth
Description
biobeat sensor is a noninvasive sensor of the the hymodynamic measures during the childbirth
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
biobeat sensor is a noninvasive sensor of the the hymodynamic measures after 24 hours of the childbirth
Description
biobeat sensor is a noninvasive sensor of the the hymodynamic measures after 24 hours of the childbirth
Time Frame
24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Pregnant woman between 18-45 years old with non cardiovascular disease Exclusion Criteria: woman with a cardiovascular disease woman who don't agree to participate in the trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuval Atsmon, MD
Organizational Affiliation
Hillel Yaffe Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hillel Yaffe Medical Center
City
Hadera
ZIP/Postal Code
3810101
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effects of Labor Stages and Interventions on Hemodynamic Measures During & After Childbirth With Noninvasive Sensors

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