PregnancyNCT00686062
Evaluation of a Decision Assisting Tool for Prenatal Testing
A study testing PT Tool - interactive, computerized, prenatal testing decision tool in people with Pregnancy, run by University of California, San Francisco at 1 site in United States.
Trial summary
This is a randomized study of an interactive, computerized descision-assisting tool for prenatal testing decision making (PT Tool) versus standard educational booklets distributed to all pregnant women by the State of California (control). Read more about this study
- Who is it for?
- Ages 16 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- PT Tool - interactive, computerized, prenatal testing decision tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 494 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2001to Apr 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Pregnant at less than 24 gestational weeks
Who cannot join
- Not able to speak English or Spanish
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adaptation and Implementation of a Prenatal Genetic Testing Decision-Assisting Tool for Clinical Use
This is a randomized study of an interactive, computerized descision-assisting tool for prenatal testing decision making (PT Tool) versus standard educational booklets distributed to all pregnant women by the State of California (control). We hypothesize that, compared to controls, women randomized to view PT Tool will have greater knowledge about prenatal testing and its potential outcomes and better risk comprehension, and that they will be more satisfied with the intervention and have lower decisional conflict.
Read the detailed description
We will evaluate the tool in a randomized controlled trial among 500 patients receiving prenatal care at one of the obstetrics clinics and practices affiliated with the University of California at San Francisco (UCSF), San Francisco General Hospital (SFGH), Kaiser San Francisco, or California Pacific Medical Center (CPMC). After completing a baseline questionnaire, participants will be randomized to view either a control or intervention group. Patients assigned to the control group will view the computerized version of the age-appropriate educational pamphlet concerning prenatal testing developed by the State of California. Patients assigned to the intervention group will use the computerized decision support tool/educational module which provides important background information about chromosomal abnormalities, and patient-tailored information about the advantages and limitations of diagnostic testing.
- Conditions
- Pregnancy
- Being tested
- Control - computerized age-appropriate prenatal testing educational brochure, PT Tool - interactive, computerized, prenatal testing decision tool
- Keywords
- Prenatal testing, Amniocentesis, Decision making, Down syndrome
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control - computerized age-appropriate prenatal testing educational brochureOther
Computerized version of the age-appropriate prenatal testing educational brochure distributed by the State of California.
PT Tool - interactive, computerized, prenatal testing decision toolOther
An interactive, computerized prenatal testing decision-assisting tool (PT Tool).
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Women in this arm view the interactive, computerized, prenatal testing decision tool (PT Tool) we created. Receives: Other: PT Tool - interactive, computerized, prenatal testing decision tool |
| 2 | Active comparator | Women in this arm view the age-appropriate computerized version of the educational pamphlet on prenatal testing developed and distributed by the State of California Receives: Other: Control - computerized age-appropriate prenatal testing educational brochure |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2008 (estimated)
- Study startApr 2001
- Primary completionApr 2003
- Study completionApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 494 participants
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Investigators
- Miriam Kuppermann, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00686062
- Sponsor's protocol ID
- H8937-16337
- Other IDs
- AHRQ Grant # R18-HS10214
- Status last verified
- May 2008
- First submitted
- 27 May 2008
- Last updated
- 29 May 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Kuppermann M, Norton ME, Gates E, Gregorich SE, Learman LA, Nakagawa S, Feldstein VA, Lewis J, Washington AE, Nease RF Jr. Computerized prenatal genetic testing decision-assisting tool: a randomized controlled trial. Obstet Gynecol. 2009 Jan;113(1):53-63. doi: 10.1097/AOG.0b013e31818e7ec4.
PubMed 19104360
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation and Implementation of a Prenatal Genetic Testing Decision-Assisting Tool for Clinical Use
- ClinicalTrials.gov ID
- NCT00686062
- Acronym / sponsor ID
- H8937-16337
- Conditions
- Pregnancy
- Keywords
- Prenatal testing, Amniocentesis, Decision making, Down syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 494 participants
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Apr 2001
- Primary completion
- Apr 2003 (actual)
- Study completion
- Apr 2004 (actual)
- First posted
- 29 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized study of an interactive, computerized descision-assisting tool for prenatal testing decision making (PT Tool) versus standard educational booklets distributed to all pregnant women by the State of California (control). We hypothesize that, compared to controls, women randomized to view PT Tool will have greater knowledge about prenatal testing and its potential outcomes and better risk comprehension, and that they will be more satisfied with the intervention and have lower decisional conflict.
Detailed description
We will evaluate the tool in a randomized controlled trial among 500 patients receiving prenatal care at one of the obstetrics clinics and practices affiliated with the University of California at San Francisco (UCSF), San Francisco General Hospital (SFGH), Kaiser San Francisco, or California Pacific Medical Center (CPMC). After completing a baseline questionnaire, participants will be randomized to view either a control or intervention group. Patients assigned to the control group will view the computerized version of the age-appropriate educational pamphlet concerning prenatal testing developed by the State of California. Patients assigned to the intervention group will use the computerized decision support tool/educational module which provides important background information about chromosomal abnormalities, and patient-tailored information about the advantages and limitations of diagnostic testing.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: PT Tool - interactive, computerized, prenatal testing decision toolWomen in this arm view the interactive, computerized, prenatal testing decision tool (PT Tool) we created. |
| 2 | Active comparator | Other: Control - computerized age-appropriate prenatal testing educational brochureWomen in this arm view the age-appropriate computerized version of the educational pamphlet on prenatal testing developed and distributed by the State of California |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Pregnant at less than 24 gestational weeks
Key exclusion criteria (1 listed)
- Not able to speak English or Spanish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control - computerized age-appropriate prenatal testing educational brochureComputerized version of the age-appropriate prenatal testing educational brochure distributed by the State of California. | Other | 2 |
| PT Tool - interactive, computerized, prenatal testing decision toolAn interactive, computerized prenatal testing decision-assisting tool (PT Tool). | Other | 1 |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2008.
- Derived from this study: PubMed 19104360Kuppermann M, Norton ME, Gates E, Gregorich SE, Learman LA, Nakagawa S, Feldstein VA, Lewis J, Washington AE, Nease RF Jr. Computerized prenatal genetic testing decision-assisting tool: a randomized controlled trial. Obstet Gynecol. 2009 Jan;113(1):53-63. doi: 10.1097/AOG.0b013e31818e7ec4.
Related trials for Pregnancy
Recruiting
The Periviable GOALS Decision Support Tool
Pregnancy Preterm, Premature Birth
Active, not recruitingPhase 4
Improving Neonatal Health Through Rapid Malaria Testing in Early Pregnancy With High-Sensitivity Diagnostics
Malaria,Falciparum, Malaria in Pregnancy
Active, not recruiting
Providing an Optimized and Empowered Pregnancy for You (POPPY) Aim 3: Randomized Controlled Trial
Pregnancy Complications, Maternal Distress
Active, not recruiting
Assessing the Use of Wearable Activity Trackers in a Pregnancy Cohort
Pregnancy Related
Not yet recruiting
Mandala Coloring in Late Pregnancy
Pregnancy, Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miriam Kuppermann, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PT Tool - interactive, computerized, prenatal testing decision tool in people with Pregnancy, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00686062, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2008; AzTrials last refreshed its copy on 31 Oct 2026.