An observational study in Trisomy 13, Trisomy 18 and Trisomy 21, sponsored by Natera, Inc.. Terminated at 29 sites in 6 countries. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-23.
Sponsored by Natera, Inc. · Observational
This prospective blinded study will assess the diagnostic capability of an informatics enhanced SNP based technology (Parental Support) to identify pregnant women who are carrying a fetus with an aneuploidy from fee floating DNA in the maternal blood.
First trimester screening is the current standard of care for pregnant women in the United States. Women with a high screening risk for trisomy then have invasive testing, which carries a risk of miscarriage, to definitively determine if the fetus has trisomy. Because of the high false negative rate of the first trimester screening, an unacceptable number of trisomic fetuses are not detected. Moreover, because of the high false positive rate, an unacceptable number of women undergo invasive follow up testing. Additional screening tests are needed that combine a high sensitivity, a low false positive rate, and minimal or no risk to the fetus.
26 studies on the registry are indexed under Trisomy 13 Syndrome; 3 are open to participants now.
This study's enrollment of 937 is close to the median of 1,000 across 22 observational studies indexed under Trisomy 13 Syndrome.
Browse Trisomy 13 Syndrome studies →Natera, Inc. is the lead sponsor of 36 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Pregnant Women
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Pregnant Women with elevated risk of trisomic pregnancy to donate a blood sample through one time blood draw
Procedure: Blood Draw
Blood will be drawn from the mother and father
Sensitivity and Specificity of the test to diagnose aneuploidy in a fetus at chromosomes 13, 18, 21, X and Y.
The primary objective is to determine the diagnostic capability of the test to detect autosomal aneuploidy (chromosomes 13, 18, 21) and sex aneuploidy (X and Y).
Time frame: Between first trimester screening (10-14 weeks GA) and invasive testing (amniocentesis or CVS).
Plan to share: No — A peer reviewed publication is planned from this study.
No publications or documents are linked to this record.
The record gives a start of Jan 2012, a primary completion of Apr 2014 and a completion of Mar 2023. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.