Fetal Electrocardiogram Extraction-Pilot Study

Huntleigh Healthcare

Status: Terminated

Conditions: Pregnancy

Study type: Observational

Funder types: Industry

Identifiers

NCT01681498

12-010

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

20 participants in 1 patient group

Pregnancy