NCT02374151

Brief Summary

This is a case control prospective study aiming to investigate the accuracy of the electrohysterography (EHG) compared to the intrauterine pressure catheter ( IUPC) that is commonly used in delivery room. Women in second phase of labor - indicated for insertion of IUPC will be asked to participate . Patients that will give their informed consent will be connected both to IUPC and EHG. Medical history and demographic parameters will be taken. The graphs will be compared and analyzed for its frequency and intensity. Delivery mode and fetal well-being will be recorded

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2016

Typical duration for all trials

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

February 22, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 27, 2015

Completed
1.3 years until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

July 6, 2018

Status Verified

July 1, 2018

Enrollment Period

2.1 years

First QC Date

February 22, 2015

Last Update Submit

July 4, 2018

Conditions

Uterine Pressure Measurement

Keywords

intrauterine pressure catheterelectrohysterography

Outcome Measures

Primary Outcomes (1)

  • Accuracy of uterine contraction sensing, comparing to invasive intrauterine catheter.

    From insertion of IUPC untill its' removal ( due to vaginal delivery or referral to instrumental/ caesarean delivery).

Secondary Outcomes (1)

  • Final delivery mode

    Third phase of delivery

Study Arms (1)

Women with IUPC

Women at term in second or third phase of labor who are indicated to have an IUPC during active labor

Device: Electrohysterography

Interventions

ElectrohysterographyDEVICE

The EHG uses a Graphium electrode patch that is applied to the abdomen and records electrical activity non-invasively

Also known as: PureTrace
Women with IUPC

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Women at term in second or third phase of labor who are indicated to have an IUPC during active labor

You may qualify if:

  • Women at term in second or third phase of labor who are indicated to have an IUPC during active labor

You may not qualify if:

  • Women not in labor
  • Active skin disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Ramat Gan, Israel

Location

Related Links

Study Officials

  • Aya Mohr Sasson, M.D

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Aya Mohr Sasson

Study Record Dates

First Submitted

February 22, 2015

First Posted

February 27, 2015

Study Start

June 1, 2016

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

July 6, 2018

Record last verified: 2018-07

Locations

IL(1)