Fetal Electrocardiogram Extraction-Pilot Study

NCT ID: NCT01681498

Last Updated: 2014-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-31

Study Completion Date

2015-05-31

Brief Summary

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This is a pilot study utilizing trans-abdominal ECG and Doppler Ultrasounds to assess the feasibility of extracting fECGs in a volunteer population.

Detailed Description

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Conditions

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Pregnancy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pregnancy

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Subjects must be pregnant women at least 18 years of age.
* Subject's fetus must be between the gestational ages of 16 weeks and term.
* Subjects must be able to tolerate 20 minutes (per fetus for which trans-abdominal ECG and Doppler ultrasounds will be performed) in the supine position.
* Subjects are willing to provide informed consent and are willing to participate in all procedures necessary to complete the study.

Exclusion Criteria

* Subjects must not have a physical or mental condition, in the opinion of the investigator, which will limit their ability to provide adequate consent.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Huntleigh Healthcare Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Menachem H. Graupe, MD

Role: PRINCIPAL_INVESTIGATOR

Wheaton Franciscan Healthcare

Locations

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Wheaton Franciscan, Inc. - St. Joseph

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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12-010

Identifier Type: -

Identifier Source: org_study_id

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