NCT00502918

Brief Summary

The study is a feasibility study to check the possibility of tracking the heart rate of the fetus and to translate the outcome to the progress of the labor

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

July 17, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 18, 2007

Completed
7 months until next milestone

Study Start

First participant enrolled

February 1, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

December 29, 2009

Status Verified

July 1, 2007

Enrollment Period

5 months

First QC Date

July 17, 2007

Last Update Submit

December 27, 2009

Conditions

ObstetricsLabor

Outcome Measures

Primary Outcomes (1)

  • Monitoring fetal heart movement

    During labour

Study Arms (1)

1

Device: CLM - HA Continuous Monitoring System Heart Application

Interventions

CLM - HA Continuous Monitoring System Heart ApplicationDEVICE
1

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Laboring women reffered to the maternity center in active labor (3cm - 7 cm) dilataion and contraction

You may qualify if:

  • Laboring women refered to the maternity center in active labor (3cm dilatation and contraction)
  • Gestational age 37-42 weeks. (GA)
  • Single Fetus.
  • Subjects who understand, agreed and signed the informed consent form.

You may not qualify if:

  • Women with abnormal placentation (Placenta previa) -
  • Abnormal fetal presentation (Breech presentation).
  • Maternal History of HIV and/or blood transmitted Hepatitis and /or active genital Herpes.
  • Need for immediate delivery (cord prolapsed or suspected placental abruption)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Aviv Soraski medical center

Tel Aviv, Israel

Location

Study Officials

  • Ariel Many, MD

    Sackler School od Medicine , Tel Aviv University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 17, 2007

First Posted

July 18, 2007

Study Start

February 1, 2008

Primary Completion

July 1, 2008

Study Completion

August 1, 2008

Last Updated

December 29, 2009

Record last verified: 2007-07

Locations

IL(1)