PreeclampsiaNCT01119183
Improving Patient Understanding of Preeclampsia
A study testing ACOG education pamphlet on preeclampsia and Preeclampsia education tool in people with Preeclampsia, run by Northwestern University at 1 site in United States.
Trial summary
Participants counseled with the preeclampsia educational tool will have a better understanding of preeclampsia than those not counseled using the tool. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia
- What is being tested?
- ACOG education pamphlet on preeclampsia and Preeclampsia education tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Jul 2010
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 12-40 weeks pregnant
- No significant hearing or vision impairment
- English speaking
Who cannot join
- Active diagnosis of preeclampsia
- Significant hearing or vision impairment
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
About this study
Participants counseled with the preeclampsia educational tool will have a better understanding of preeclampsia than those not counseled using the tool.
- Conditions
- Preeclampsia
- Being tested
- ACOG education pamphlet on preeclampsia, Preeclampsia education tool
- Keywords
- Patient understanding and counseling
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACOG education pamphlet on preeclampsiaBehavioural
The ACOG pamphlet on preeclampsia will be offered to this group
Preeclampsia education toolBehavioural
The newly created preeclampsia educational tool will be offered to this group
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Not described |
| 2 | Active comparator | Not described Receives: Behavioral: ACOG education pamphlet on preeclampsia |
| 3 | Experimental | Not described Receives: Behavioral: Preeclampsia education tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved understanding of preeclampsia
Understanding of preeclampsia will be assessed through a questionnaire that asks a series of closed ended questions about preeclampsia as well as a single open ended question. This questionnaire has been used in a prior study and has proven to be a useful assessment of patient knowledge.
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2010 (estimated)
- Study startApr 2010
- Primary completionJul 2010
- Study completionJul 2010
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 PreeclampsiaStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01119183
- Sponsor's protocol ID
- STU00006039
- Status last verified
- Jun 2022
- First submitted
- 23 Apr 2010
- Last updated
- 13 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
You WB, Wolf MS, Bailey SC, Grobman WA. Improving patient understanding of preeclampsia: a randomized controlled trial. Am J Obstet Gynecol. 2012 May;206(5):431.e1-5. doi: 10.1016/j.ajog.2012.03.006. Epub 2012 Mar 13.
PubMed 22542120
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Patient Understanding of Preeclampsia
- ClinicalTrials.gov ID
- NCT01119183
- Acronym / sponsor ID
- STU00006039
- Conditions
- Preeclampsia
- Keywords
- Patient understanding and counseling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 7 May 2010 (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.
Participants counseled with the preeclampsia educational tool will have a better understanding of preeclampsia than those not counseled using the tool.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | – |
| 2 | Active comparator | Behavioral: ACOG education pamphlet on preeclampsia |
| 3 | Experimental | Behavioral: Preeclampsia education tool |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 12-40 weeks pregnant
- No significant hearing or vision impairment
- English speaking
Key exclusion criteria (3 listed)
- Active diagnosis of preeclampsia
- Significant hearing or vision impairment
- Non-English speaking
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 |
|---|---|---|
| ACOG education pamphlet on preeclampsiaThe ACOG pamphlet on preeclampsia will be offered to this group | Behavioural | 2 |
| Preeclampsia education toolThe newly created preeclampsia educational tool will be offered to this group | Behavioural | 3 |
Primary outcome
Improved understanding of preeclampsia
Time frame: one week
Understanding of preeclampsia will be assessed through a questionnaire that asks a series of closed ended questions about preeclampsia as well as a single open ended question. This questionnaire has been used in a prior study and has proven to be a useful assessment of patient knowledge.
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 13 Jun 2022.
- Derived from this study: PubMed 22542120You WB, Wolf MS, Bailey SC, Grobman WA. Improving patient understanding of preeclampsia: a randomized controlled trial. Am J Obstet Gynecol. 2012 May;206(5):431.e1-5. doi: 10.1016/j.ajog.2012.03.006. Epub 2012 Mar 13.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACOG education pamphlet on preeclampsia and Preeclampsia education tool in people with Preeclampsia, run by Northwestern University 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 3 inclusion and 3 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 13 Jun 2022. 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.
What does the primary outcome measure?
Improved understanding of preeclampsia (time frame: one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01119183, 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 13 Jun 2022.