CompletedNot Applicable

Clinical Performance of NIPT in Multiple Gestation Pregnancies

United States2,000 participantsStarted 2020-03-01

Plain-language summary

This study plans to evaluate the clinical performance of the MaterniT21 PLUS and/or GENOME Laboratory Developed Test, in the detection of fetal trisomy 21 in circulating cell-free DNA extracted from maternal blood samples obtained from women pregnant with a twin gestation.

Who can participate

Age range

18 Years

Sex

FEMALE

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: * subject pregnant with a multiple gestation and received NIPT from Sequenom Laboratories; * subject was 18 or older at the time of NIPT Exclusion Criteria: * none

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

Determination of sensitivity of NIPT detection of trisomy 21 among a population of women with twin gestations.

Timeframe: time from maternal blood draw to delivery

Determination of specificity of NIPT detection of trisomy 21 among a population of women with twin gestations.

Timeframe: time from maternal blood draw to delivery

Trial details

NCT IDNCT04488393

SponsorUniversity of Pennsylvania

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-11-15

View on ClinicalTrials.gov More Trisomy 21 in Fetus trials

Who can participate

Age range

18 Years

Sex

FEMALE

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: * subject pregnant with a multiple gestation and received NIPT from Sequenom Laboratories; * subject was 18 or older at the time of NIPT Exclusion Criteria: * none

What they're measuring

Determination of sensitivity of NIPT detection of trisomy 21 among a population of women with twin gestations.

Timeframe: time from maternal blood draw to delivery

Determination of specificity of NIPT detection of trisomy 21 among a population of women with twin gestations.

Timeframe: time from maternal blood draw to delivery