Actively Recruiting
Clinical Follow-up of Pregnant Subjects Undergoing NIPT
Led by Sequenom, Inc. · Updated on 2024-10-16
25000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Sequenom, Inc.
Lead Sponsor
I
Integrated Genetics
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to collect pregnancy outcome information from women who have undergone non-invasive pregnancy testing (NIPT) to check the genetic status of their fetus. The study evaluates the performance of routine improvements to the NIPT assay and seeks to identify factors linked to negative pregnancy outcomes. This observational study focuses on pregnant women aged 18 and older who received testing through Sequenom or Integrated Genetics. Participants in this study have already undergone NIPT as part of their routine care. Researchers will review the testing results and pregnancy outcomes without providing any additional treatments or interventions. The study uses data collected from the non-invasive testing device and gathers information about pregnancy progress and outcomes to analyze test effectiveness and related characteristics. During the study, researchers will collect and analyze data about pregnancy outcomes up to nine months after testing. No extra procedures or visits are required beyond standard care. The main goal is to assess how well the NIPT performs clinically and to understand factors that may influence pregnancy results. Participation involves sharing pregnancy outcome information for research purposes only.
CONDITIONS
Brief Title
Clinical Follow-up of Pregnant Subjects Undergoing NIPT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to delivery
Participants undergo non-invasive pregnancy testing (NIPT) as part of routine clinical care.
1 visit (in-person) for testing
Duration - Up to 9 months
Participants are followed to collect pregnancy outcome data for analysis.
Follow-up contacts aligned with pregnancy milestones
Trial Site Locations
Total: 1 location
1
Integrated Genetics
Westborough, Massachusetts, United States, 01581
Actively Recruiting
Research Team
K
Kimberly Fanelli, MS, CGC
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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