Fetal Heart Disorder Clinical Trial
Official title:
Atomic Magnetometer for Fetal Biomagnetism
NCT number | NCT03057665 |
Other study ID # | H-2008-0099 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 2010 |
Est. completion date | April 1, 2019 |
Verified date | May 2019 |
Source | University of Wisconsin, Madison |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The goal of this study is the evaluation of an atomic magnetometer that is practical for human biomagnetism studies. The investigators have built a device that has the necessary sensitivity, and will be testing it on a small number of adults and approximately 30 healthy pregnant subjects, in preparation for beginning pre-clinical studies of high-risk pregnancies.
Status | Completed |
Enrollment | 43 |
Est. completion date | April 1, 2019 |
Est. primary completion date | April 1, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - The subjects will be asked if they consider themselves healthy, if they are able to sit or lie still for 5 minute periods during data acquisition, if they have large metal plates, screws, or devices, and if they are pregnant. Exclusion Criteria: - Participants who self-identify as being unhealthy or having complications with their pregnancy. In addition, vulnerable populations such as prisoners, veterans, individuals with impaired decision-making capabilities, and non-English speakers will be excluded. |
Country | Name | City | State |
---|---|---|---|
United States | Biomagnetism Laboratory | Madison | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
University of Wisconsin, Madison |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assessment of Atomic Magnetometer | Measure single-to-noise for acquisition of fetal magnetocardiograms | 20-35 week gestation period |