Follow-up on pregnancy outcomes after non-invasive genetic testing
Clinical Follow-up of Pregnant Subjects Undergoing NIPT
This study looks at the pregnancy outcomes of people who had non-invasive genetic testing to see how it affects their pregnancies and any potential risks.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 25000 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Sequenom, Inc. Industry-sponsored |
| Locations | 1 site (Westborough, Massachusetts) |
| Trial ID | NCT04595201 on ClinicalTrials.gov |
What this trial studies
This study collects data on pregnancy outcomes for patients who have undergone non-invasive prenatal testing (NIPT) to assess fetal genetic status. It aims to analyze the effectiveness of routine assay enhancements and identify factors linked to adverse obstetric outcomes. By following pregnant individuals who received NIPT, the study seeks to provide insights into the implications of genetic testing during pregnancy.
Who should consider this trial
Good fit: Ideal candidates are pregnant individuals aged 18 or older who have received NIPT from Sequenom/Integrated Genetics.
Not a fit: Patients who are not pregnant or have not undergone NIPT will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve understanding of the relationship between NIPT results and pregnancy outcomes, potentially enhancing prenatal care.
How similar studies have performed: Other studies have explored the outcomes of NIPT, suggesting that this approach is supported by existing research but may still yield novel insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * None
Where this trial is running
Westborough, Massachusetts
- Integrated Genetics — Westborough, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Kimberly Fanelli, MS, CGC — Integrated Genetics
- Study coordinator: Kimberly Fanelli, MS, CGC
- Email: kimberly.fanelli@integratedgenetics.com
- Phone: 603-714-5063
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.