NCT03838965

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 12, 2019

Completed
17 days until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2020

Completed
Last Updated

June 23, 2022

Status Verified

June 1, 2022

Enrollment Period

1.8 years

First QC Date

January 30, 2019

Last Update Submit

June 22, 2022

Conditions

Rupture of Membranes; PrematureCesarean Section; InfectionPreeclampsia

Outcome Measures

Primary Outcomes (1)

  • 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

    24 hours

Secondary Outcomes (1)

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

    24 hours

Study Arms (1)

biobeat sensor

EXPERIMENTAL
Device: biobeat sensor

Interventions

biobeat sensorDEVICE

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

biobeat sensor

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 3810101, Israel

Location

MeSH Terms

Conditions

Fetal Membranes, Premature RuptureInfectionsPre-Eclampsia

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesHypertension, Pregnancy-Induced

Study Officials

  • Yuval Atsmon, MD

    Hillel Yaffe Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2019

First Posted

February 12, 2019

Study Start

March 1, 2019

Primary Completion

December 16, 2020

Study Completion

December 16, 2020

Last Updated

June 23, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)