Acquisition of Fetal ECG with Intact Membranes
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 16-009090
Sponsor Protocol Number: 16-009090
About this study
The purpose of this study is to determine if it is possible to record a high quality fetal ECG using signals acquired inside of the birth canal (vagina).
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Pregnant women admitted to Rochester Methodist Hospital with an intrauterine pregnancy at term (≥37 0/7 weeks) who are undergoing clinically indicated pelvic examinations and standard fetal monitoring.
- Intact Membranes
- Singleton gestation
- 18 years of age or more
- Willing to give informed consent
Exclusion Criteria:
- High risk pregnancy specifically - incompetent os/placenta previa/PIH/Elderly Primi gravida /previous surgery
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Kyle Traynor, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available