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NCT01966991 · ClinicalTrials.gov registry record
Prenatal Screening for Down Syndrome With DNAFirst
A clinical trial, sponsored by Women and Infants Hospital of Rhode Island.
- Completed
- Registry status
- 100
- Enrollment target
NCT01966991: Completed study, sponsored by Women and Infants Hospital of Rhode Island.
NCT01966991 is a clinical trial that has completed, run by Women and Infants Hospital of Rhode Island. The registered enrollment target is 100 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01966991 has completed, sponsored by Women and Infants Hospital of Rhode Island.
- COMPLETED
- Registry status
- 100 participants
- Enrollment target
Study Summary
This study will explore how maternal plasma circulating cell free DNA (ccfDNA) can be used as a primary screening test for Down syndrome as part of routine clinical care in the general pregnancy population. Plasma ccfDNA testing is currently recommended only for use as a secondary screen for 'high-risk' women (i.e., women whose risk factors for trisomy make them candidates for invasive testing such as chorionic villous sampling or amniocentesis). Because most women in this 'high-risk' category are carrying unaffected fetuses, many 'unnecessary' procedures are completed in order to identify the few women whose fetuses have a chromosomal disorder. This creates expense, anxiety, and most importantly, loss of unaffected fetuses due to procedure related miscarriage. Plasma DNA testing is now being used to reduce significantly the number of women with unaffected fetuses undergoing invasive testing. Applying such testing as a 'first-line' screen has not been well-explored, despite calls from several clinical professional societies to do so. The investigators intent is to introduce, under carefully monitored conditions, ccfDNA testing through Rhode Island primary prenatal practices to the general pregnancy population. Education/orientation of prenatal care providers, their staffs, and their patients will be carefully orchestrated, and implementation issues identified and addressed. Telephone surveys of consented patients will elicit responses to their understanding of the test, their satisfaction with the process, and a comparison of their experience with serum screening in a prior pregnancy. Knowledge gained from this study will help validate new screening paradigms involving ccfDNA testing. The study is not designed to estimate Down syndrome detection rates with any confidence, but can provide information on uptake rates, failure rates, screen positive rates, and the decision-making of women with positive test results.
Primary Outcome
A telephone survey will be administered to women who have undergone ccfDNA testing (DNAFirst) and who have provided written permission to be contacted specifically for this purpose.Included will be questions designed to elicit understanding of the results, implications of positive and negative results, comparison with earlier serum-screening experience, and reasons for accepting/declining ancillary testing (sex aneuploidy).
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2014-06 |
| Est. Completion | 2015-12 |
What the finished NCT01966991 record still lists
NCT01966991 is an observational study that tracks outcomes without assigning an intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01966991 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01966991 about?
NCT01966991 is a clinical study titled "Prenatal Screening for Down Syndrome With DNAFirst". This study will explore how maternal plasma circulating cell free DNA (ccfDNA) can be used as a primary screening test for Down syndrome as part of routine clinical care in the general pregnancy population. Plasma ccfDNA testing is currently recommended only for use as a secondary screen for 'high-r...
What is the current status of trial NCT01966991?
This trial is currently completed. The enrollment target is 100 participants. The study started on 2014-06. Estimated completion is 2015-12.
Who is sponsoring clinical trial NCT01966991?
This trial is sponsored by Women and Infants Hospital of Rhode Island, which has 65 total clinical trials registered on ClinicalTrials.gov.
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