NCT01681498

Brief Summary

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

Trial Health

57
Monitor

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 May 2013

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

August 30, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 10, 2012

Completed
8 months until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

September 3, 2014

Status Verified

September 1, 2014

Enrollment Period

2 years

First QC Date

August 30, 2012

Last Update Submit

September 1, 2014

Conditions

Pregnancy

Keywords

pregnantfetal ecgecg

Outcome Measures

Primary Outcomes (1)

  • Beat-to-beat fetal heart rate will be compared to the Doppler result.

    Beat-to-beat fetal heart rate will be compared to the Doppler result using Pearson Correlation. Timing of PR, QT, and QS, if visible, will be compared with published normative values from the neonatology literature as these values are not otherwise obtainable in an ongoing pregnancy.

    2 years

Secondary Outcomes (1)

  • Evaluate the presence of other fECG intervals.

    2 years

Study Arms (1)

Pregnancy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Prenatal care clinic

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wheaton Franciscan, Inc. - St. Joseph

Milwaukee, Wisconsin, 53210, United States

Location

Study Officials

  • Menachem H. Graupe, MD

    Wheaton Franciscan Healthcare

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2012

First Posted

September 10, 2012

Study Start

May 1, 2013

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

September 3, 2014

Record last verified: 2014-09

Locations

US(1)