CompletedNot Applicable

High Risk Multiple Gestation Study

United States99 participantsStarted 2014-08

Plain-language summary

The objectives of the clinical study are to demonstrate the accuracy of our proprietary algorithm 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 other currently available screening tests. This will result in fewer unnecessary amniocenteses and Chorionic Villus Sample (CVS) procedures, which are associated with a risk of miscarriage.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 18 or older at enrollment * Clinically confirmed multiple gestation pregnancy * Pregnancy at high risk for genetic aneuploidy as defined below: * Confirmed positive aneuploidy by invasive testing * Non invasive prenatal testing "high risk" result * Serum screening risk of greater than 1:100 * Ultrasound abnormalities indicative of aneuploidy * Structural abnormality of the posterior fossa * Holoprosencephaly * Structural cardiac anomaly * Omphalocele * Nuchal translucency greater than or equal to 3.5 mm or a nuchal fold greater Hydrops of unknown etiology * Age ≥ 38 years at delivery (if serum screening risk is not less than 1:100) * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Screening capability of proprietary algorithm in the form of a risk results classified as positive result for aneuploidy, negative result for aneuploidy or 'no call.'

Timeframe: 4 years

Trial details

NCT IDNCT02278874

SponsorNatera, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2018-12-01

View on ClinicalTrials.gov More Trisomy 13 trials