Back to resultsThe 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
About this trial
This is an interventional diagnostic trial for Rupture of Membranes; Premature
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
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
NCT ID
NCT03838965
First Posted
January 30, 2019
Last Updated
June 22, 2022
Sponsor
Hillel Yaffe Medical Center
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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