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New tool aims to help pregnant women navigate genetic testing decisions

NCT ID NCT03420274

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a shared decision-making tool called NEST to help pregnant women understand and choose noninvasive prenatal testing (NIPT). Over 600 pregnant women participated, comparing those who used the tool with those who received usual care. The goal was to see if the tool improved informed decision-making about genetic screening.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
shared decision-making tool (NEST)
What this could lead to
If successful, this could improve how doctors and patients discuss prenatal genetic testing, leading to more informed choices.
What could go wrong
This is a behavioral study, not a treatment trial. Results may not apply to all clinics or populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

691 people

The number who actually took part.

Started

Feb 2018

Finished

Jun 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

I. Pregnant women Inclusion criteria: 1. 18 years of age or older 2. Present for their initial prenatal visit care with one of the providers enrolled in the study 3. Able to provide consent to participate in the study 4. Available for a follow up in the 1st or 2nd trimester of pregnancy 5. Have a viable intrauterine pregnancy 6. Present for care between 7-12 weeks estimated gestation age (EGA) Since criteria 5 and 6 will not be determined until the conclusion of the first prenatal visit, women who meet criteria 1-4 will be eligible for participation. Exclusion Criteria: Women who are: 1. Less than 18 years of age 2. Not currently pregnant or an intrauterine pregnancy has not yet been established 3. Inability to provide informed consent for research participation II. Self-identified partners of pregnant women Inclusion criteria: 1. 18 years of age or older 2. The male or female partner (such as partner or mother/aunt/grandmother serving in the role of primary collaborative decision-maker in place of a partner) of a pregnant woman who has participated in the research 3. Participating in decision-making about the pregnancy 4. Ability to read and speak English 5. Ability to provide informed consent for research participation Exclusion criteria: 1. Younger than 18 years of age 2. Not currently involved in the pregnancy or decision-making about prenatal care 3. Inability to speak or read English 4. Inability to provide informed consent for research participation III. Prenatal healthcare providers Inclusion criteria: 1. Board certified or board-eligible CNM, OB/GYNs or MFMs 2. Deliver outpatient prenatal care at one of the regional practices of the Cleveland Clinic 3. Able to read and speak English 4. Able to provide consent for research participation Exclusion criteria: 1. OB/GYNs who do not currently provide prenatal care 2. Medical students, residents, and fellows 3. Hospitalists who do not provide outpatient obstetric care

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109, United States

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