Clinical Utility of the Addition of a SNP-based NIPT Zygosity Determination in TWIN Pregnancy Management

Overview

Información sobre este estudio

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.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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.

 

 

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Rochester, Minn.

Investigador principal de Mayo Clinic

Myra Wick, M.D., Ph.D.

Cerrado para la inscripción

More information

Publicaciones

Publications are currently not available
.
CLS-20524216

Mayo Clinic Footer