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NCT03420274 · ClinicalTrials.gov registry record · NA
Ensuring Patients' Informed Access to Noninvasive Prenatal Testing
A NA study of Pregnancy Complications and Genetic Disease, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- NA
- Development phase
- 691
- Enrollment target
- 2
- Study locations
NCT03420274 is a NA study of Pregnancy Complications and Genetic Disease that has completed, run by The Cleveland Clinic. The registered enrollment target is 691 participants, below the 3,773-participant average among 39 other Pregnancy Complications trials with a reported enrollment target (82% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT03420274, a NA study of Pregnancy Complications and Genetic Disease, has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- NA
- Development phase
- 691 participants
- Enrollment target
- 2
- Study locations
Study Summary
Noninvasive prenatal genetic testing (NIPT) is an important new screening test option provided to pregnant women in the first trimester of pregnancy. The advantage of this screen is that is provides information about the risk of trisomy 13, trisomy 18, and trisomy 21 with greater accuracy than conventional screens. At the same time, NIPT can produce information about the risk of a cohort of other fetal genetic variants, including sex chromosome aneuploidies and microdeletion syndromes. While not yet clinically available for whole exome sequencing, the potential for this next clinical application already exists. The challenge is that, while this is an important new test, there are little data about how to best structure patient-centered decisions about NIPTs use, including decisions if to use this screen and how the information may directly inform subsequent prenatal care decisions. The purpose of this study is to gain formative data about current practice patterns with respect to how NIPT is discussed in the clinical visit and to use these data to help inform best practices for NIPTs continued use in the clinical setting.
Conditions Studied
Interventions
- BEHAVIORAL Usual care
- BEHAVIORAL NEST
Study Locations (2)
Ohio
- MetroHealth Medical Center - Cleveland
- Cleveland Clinic - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 691 participants |
| Start Date | 2018-02-19 |
| Est. Completion | 2023-06-15 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03420274
The ClinicalTrials.gov registry entry for NCT03420274 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 691 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,773-participant average among 39 other Pregnancy Complications trials with a reported enrollment target (82% lower). The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Pregnancy Complications appearing as the primary indexed condition, and to 2 interventions - of which Usual care is the first listed.
NCT03420274 reports 2 study locations spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT03420274 about?
NCT03420274 is a clinical study titled "Ensuring Patients' Informed Access to Noninvasive Prenatal Testing". Noninvasive prenatal genetic testing (NIPT) is an important new screening test option provided to pregnant women in the first trimester of pregnancy. The advantage of this screen is that is provides information about the risk of trisomy 13, trisomy 18, and trisomy 21 with greater accuracy than conve...
What is the current status of trial NCT03420274?
This trial is currently completed. It is a NA study. The enrollment target is 691 participants. The study started on 2018-02-19. Estimated completion is 2023-06-15.
What conditions does trial NCT03420274 study?
This clinical trial studies the following conditions: Pregnancy Complications, Genetic Disease, Genetic Syndrome, Prenatal Disorder, Prenatal Maternal Abnormality.
What interventions are being tested in trial NCT03420274?
The interventions under investigation include: Usual care (BEHAVIORAL), NEST (BEHAVIORAL).
Who is sponsoring clinical trial NCT03420274?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03420274 being conducted?
This trial has 2 study locations across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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