N/A
N=197
Use of a Novel Computerized Decision Aid for Prenatal Aneuploidy Screening
Aneuploidy · Pregnancy Complications
Bottom Line
View on ClinicalTrials.gov: NCT02991729 ↗Enrolled (actual)
197
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: Knowledge Score — 10.6; 10.2 score on a scale — p=0.929
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- iPad-based decision aid (Other); Genetic counseling appointment (Other)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Jan 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Knowledge Score |
10.6; 10.2 | 0.929 |
| SECONDARY Decisional Conflict Score |
NA; 1.6; 1.7; 0.2 | 0.369 |
| SECONDARY Test Chosen |
17; 11; 35; 28; 27; 25 | — |
| SECONDARY Supplementary Tests Performed |
2; 1; 2; 1 | — |
Summary
The investigators aim to assess whether use of a novel, tablet-based computerized decision aid for aneuploidy screening is similar to routine care with a brief genetic counseling visit in improving patient knowledge and decreasing decisional conflict.
Eligibility Criteria
Inclusion Criteria
- Pregnancy at less than 22 weeks gestation
- English or Spanish speaking
- Undergoing genetic counseling at North Carolina Women's Hospital for aneuploidy screening
Exclusion Criteria
- Known fetal anomalies
- Known multiple gestations
- Prior genetic counseling or aneuploidy screening in current pregnancy
Data sourced from ClinicalTrials.gov (NCT02991729). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.