UnknownNot Applicable

Whole Blood Specimen Collection From Pregnant Subjects

United States5,000 participantsStarted 2015-03

Plain-language summary

To obtain whole blood specimens from pregnant subjects to be used for research and development and clinical validation studies of prenatal assays.

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 willing to provide consent to have up to 50 mL of whole blood collected at one or more monthly (≥25 days) clinic visits * Subject is pregnant carrying a singleton fetus of 10 to 26 weeks gestational age inclusive * Subject is 18 years of age or older * Subject is at an increased risk for one or more of the following: * fetal gene and chromosome abnormalities * congenital fetal infection * known to possess irregular blood group antigens (subject or father of the baby) * known to have some other condition amenable to noninvasive prenatal testing Exclusion Criteria: * Pregnancy is non-viable

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

Whole blood collection

Timeframe: One or more monthly clinic visits (≥25 days apart) over 13 weeks

Trial details

NCT IDNCT02430584

SponsorProgenity, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2021-03

View on ClinicalTrials.gov More Down Syndrome trials