Clinical Follow-up of Pregnant Subjects Undergoing NIPT
ConditionPregnancy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorSequenom, Inc.
About this trial
To obtain pregnancy outcome data from patients screened for fetal genetic status using non-invasive pregnancy testing (NIPT).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subject was pregnant and received NIPT from Sequenom/Integrated Genetics
Subject was 18 years of age or older at the time of NIPT
Pregnancy outcome is available
Disqualifiers
None
Trial population
The Study Population will consist of women 18 years of age and older who underwent testing with a Sequenom NIPT and whose pregnancies should have outcome based upon gestational age at the time of testing.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
NIPT
DeviceNon-invasive pregnancy testing
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
NIPT clinical outcome performance
Sensitivity
Time frame
9 months2
NIPT clinical outcome performance
Specificity
Time frame
9 months3
NIPT clinical outcome performance
Positive predictive value
Time frame
9 months4
NIPT clinical outcome performance
Negative predictive value
Time frame
9 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Sequenom, Inc.
Lead sponsor
Integrated Genetics
Collaborator
Source ClinicalTrials.gov