Multiple Gestation Study

Natera

Status: Completed

Conditions: Trisomy 18; Trisomy 13; Trisomy 21; Sex Chromosome Abnormalities

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT02278536

13-016-NPT

Details and patient eligibility

About

The objectives of the clinical study are to demonstrate the accuracy of our new NATUS diagnostic method to determine the genetic health of the developing fetuses in a multiple gestation pregnancy from a maternal blood sample. The long term goal of this study will be the development of a method of minimally invasive prenatal diagnosis that has a higher sensitivity and lower false positive rate in the intended population (e.g. multiple gestation pregnancies) than any currently available screening tests. This will result in fewer unnecessary amniocenteses and CVS procedures, which are associated with a risk of miscarriage.

Enrollment: 354 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 18 or older at enrollment
• Clinically confirmed multiple gestation pregnancy
• Gestational age between ≥ 9 weeks, 0 days and ≤26 weeks 0 days by best obstetrical estimate
• Able to provide informed consent

Exclusion criteria

• Women carrying singleton pregnancy
• Surrogate or egg donor used

Trial design

354 participants in 2 patient groups

Multiple high risk gestation pregnancies

Description:

women pregnant with twins or triplets at high risk for aneuploidy

Multiple low risk gestation pregnancies

Description:

women pregnant with twins or triplets at low risk for aneuploidy