Use of a Novel Computerized Decision Aid for Prenatal Aneuploidy Screening

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

197 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-20

Study Completion Date

2018-01-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Non-Invasive Screening for Fetal Aneuploidy

NCT02317965

Down Syndrome Edwards Syndrome

UNKNOWN

Development of a Prenatal Test for Fetal Aneuploidy Detection

NCT01451671

Fetal Complications

COMPLETED

Noninvasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker

NCT00971334

Pregnancy Aneuploidy Down Syndrome +1 more

COMPLETED

Non-Invasive Screening for Fetal Aneuploidy

NCT00847990

Down Syndrome Edwards Syndrome

COMPLETED

Does an Educational Video for Aneuploidy Screening Improve Informed Choice Among Pregnant Women?

NCT05492981

Aneuploidy Down Syndrome Pregnancy Early

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

184 women will be randomized in a 1:1 fashion to use of a novel computerized iPad-based decision aid in addition to routine counseling or routine counseling only during a single study visit. This decision aid was developed at a 10th grade literacy level using input from Maternal Fetal Medicine physicians and certified genetic counselors, and piloted by 20 English and Spanish speaking women of varying education levels. Following completion of genetic counseling, participants will complete several surveys assessing knowledge and decision conflict. Data will be abstracted regarding demographics, screening and diagnostic testing uptake, and testing results.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Aneuploidy Pregnancy Complications

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Routine care

These patients will receive routine care at our institution for counseling on aneuploidy screening; they will be counseled by a genetic counselor on options, and following counseling, will select their test of choice. All patients will complete a knowledge and demographics questionnaire prior to genetic counseling. Patients in this arm will then complete a knowledge and decisional conflict survey immediately following genetic counseling.

Group Type ACTIVE_COMPARATOR

Genetic counseling appointment

Intervention Type OTHER

All participants will undergo an approximately 15 minute educational genetic counseling appointment regarding aneuploidy screening options. Should family history concerns be identified on intake, this visit may be extended to include a discussion of additional issues.

Experimental

These patients will use an iPad-based decision aid explaining options for aneuploidy screening and testing. They will then immediately be counseled by a genetic counselor on their options as is routine at our institution, and following counseling, will select their test of choice. All patients will complete a knowledge and demographics questionnaire prior to genetic counseling. Patients in this arm will then complete a knowledge and decisional conflict survey following use of the decision aid, and again immediately following genetic counseling.

Group Type EXPERIMENTAL

iPad-based decision aid

Intervention Type OTHER

This is a novel decision aid developed by genetic counselors and Maternal Fetal Medicine physicians. It is used via an iPad and is interactive. It is available in English and Spanish has been piloted by 20 English and Spanish speaking women. It takes approximately 15 minutes to complete.

Genetic counseling appointment

Intervention Type OTHER

All participants will undergo an approximately 15 minute educational genetic counseling appointment regarding aneuploidy screening options. Should family history concerns be identified on intake, this visit may be extended to include a discussion of additional issues.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

iPad-based decision aid

This is a novel decision aid developed by genetic counselors and Maternal Fetal Medicine physicians. It is used via an iPad and is interactive. It is available in English and Spanish has been piloted by 20 English and Spanish speaking women. It takes approximately 15 minutes to complete.

Intervention Type OTHER

Genetic counseling appointment

All participants will undergo an approximately 15 minute educational genetic counseling appointment regarding aneuploidy screening options. Should family history concerns be identified on intake, this visit may be extended to include a discussion of additional issues.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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