Clinical Utility of the Addition of a SNP-based NIPT Zygosity Determination in TWIN Pregnancy Management
Overview
Tab Title Description
Study type
ObservationalDescribes 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: 21-008126
About this study
The primary objective of the study is to assess the clinical utility of combining noninvasive prenatal testing (NIPT)-based zygosity measurements with ultrasound chorionicity assessments for the management of twin pregnancies, as measured by the following endpoints: the overall frequency of NIPT-determined zygosity and monozygosity among twin pregnancies, the frequency of NIPT-determined zygosity rate among monochorionic and dichorionic twin pregnancies, and the proportion of twin pregnancies with twin-twin transfusion syndrome (TTTS) that are diagnosed late as compared with historical rates.
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:
- Female patients age 18 at the time of signing informed consent, up to 55 years of age.
- Ultrasound confirmation of twin pregnancy no later than 20 weeks gestational age (GA), and prior to Panorama.
- Panorama planned no later than 20 weeks GA.
- Willing and able to provide written informed consent.
- Willing and able to comply with institution’s standard of care prenatal procedures, including ultrasound assessments and Panorama.
- Note: subjects with known major congenital anomalies, known unbalanced chromosomal complement or ruptured membranes, may be enrolled in the study.
Exclusion Criteria:
- Singleton or non-twin multiple pregnancy.
- Ultrasound confirmation of twin pregnancy at 20 weeks 1 day GA or later.
- Patient has received a Panorama test and the enrolling physician has received the Panorama test results prior to any ultrasound assessment of chorionicity & amnionicity.
- Panorama testing is planned at 20 weeks 1 day GA or later.
- Any confounding complication or condition that, in the opinion of the investigators, precludes participation in the study, such as evidence of TTTS or other monochorionic pregnancy complication already at the time of enrollment.
- Unwilling or unable to participate in the institution’s standard of care prenatal ultrasound and/or testing with Panorama.
- Unwilling or unable to provide written informed consent.
Eligibility last updated 4/26/22. Questions regarding updates should be directed to the study team contact.
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 Myra Wick, M.D., Ph.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available