Non Invasive Prenatal Testing (NIPT) of Single-gene Disorders (NCT02339402) | Clinical Trial Compass
UnknownNot Applicable
Non Invasive Prenatal Testing (NIPT) of Single-gene Disorders
Netherlands160 participantsStarted 2014-06
Plain-language summary
Developing a new non-invasive prenatal test for single gene disorders from cell free fetal DNA, retrieved from the mothers blood.
Who can participate
Age range
18 Years – 50 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:
* the pregnant woman is scheduled for or has recently undergone invasive prenatal testing (regular care) because of one of the following reasons:
* the fetus is at high risk of a having inherited a single-gene disorder from his/her affected parent(s).
* the fetus is at risk of having a de dominant novo disorder on the basis of ultrasonography findings.
* the pregnant woman is 18 years or older
* the pregnant woman has sufficient understanding of Dutch language and is able to give informed consent
Exclusion Criteria:
* if in the opinion of the treating physician psychological distress is so severe that asking for participation is not safe
* the pregnant woman is treated for a malignancy
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
1
Development of a targeted molecular test (mostly standard PCR or real-time PCR) for non-invasive prenatal testing of single-gene disorders.