PreeclampsiaNCT00201500
Left Ventricular and Endothelial Function in Preeclampsia
An observational study of Preeclampsia, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The purpose of this study is (1) to examine whether the left ventricular function is impaired in women with preeclampsia relative to healthy pregnant controls, (2) to examine whether the endothelial function is impaired in women with preeclampsia relative to healthy pregnant controls, and (3) to examine whether there… 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
- How many people
- 39 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2004to Mar 2006
- Phase
- Observational
- 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
Study population: Women with preeclampsia and women with normotensive pregnancies.
Who may be able to join
- >18 years of age
- Case: Clinical diagnosis of preeclampsia,
- Control: Systolic BP <140 mmHg and diastolic BP <90 mmHg
Who cannot join
- Known hypertension or other cardiovascular disease
- Diabetes/gestational diabetes
- Multiple gestation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Left Ventricular and Endothelial Function in Preeclampsia, a Case Control Study
The purpose of this study is (1) to examine whether the left ventricular function is impaired in women with preeclampsia relative to healthy pregnant controls, (2) to examine whether the endothelial function is impaired in women with preeclampsia relative to healthy pregnant controls, and (3) to examine whether there is a post partum impairment in left ventricular and endothelial function.
- Conditions
- Preeclampsia
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| preeclampsia | women with preeclampsia | |
| controls | healthy pregnant women |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left Ventricular Function
Measured: 3 months
Endothelial Function
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startOct 2004
- Primary completionDec 2005
- Study completionMar 2006
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.
- 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
- Observational
- Observational model
- Case-control
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Nord-Trøndelag HF
- Responsible party
- Sponsor
- Investigators
- Stig A Slørdahl, Professor, Study chair, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00201500
- Sponsor's protocol ID
- PEETLV
- Status last verified
- Aug 2016
- First submitted
- 16 Sep 2005
- Last updated
- 4 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Tyldum EV, Backe B, Stoylen A, Slordahl SA. Maternal left ventricular and endothelial functions in preeclampsia. Acta Obstet Gynecol Scand. 2012 May;91(5):566-73. doi: 10.1111/j.1600-0412.2011.01282.x.
PubMed 21943052
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Ventricular and Endothelial Function in Preeclampsia, a Case Control Study
- ClinicalTrials.gov ID
- NCT00201500
- Acronym / sponsor ID
- PEETLV
- Conditions
- Preeclampsia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Helse Nord-Trøndelag HF
- Study start
- Oct 2004
- Primary completion
- Dec 2005 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 20 Sep 2005 (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.
The purpose of this study is (1) to examine whether the left ventricular function is impaired in women with preeclampsia relative to healthy pregnant controls, (2) to examine whether the endothelial function is impaired in women with preeclampsia relative to healthy pregnant controls, and (3) to examine whether there is a post partum impairment in left ventricular and endothelial function.
Study design
- Observational model
- Case-control
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| preeclampsia | – | –women with preeclampsia |
| controls | – | –healthy pregnant women |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women with preeclampsia and women with normotensive pregnancies.
Key inclusion criteria (3 listed)
- >18 years of age
- Case: Clinical diagnosis of preeclampsia,
- Control: Systolic BP <140 mmHg and diastolic BP <90 mmHg
Key exclusion criteria (3 listed)
- Known hypertension or other cardiovascular disease
- Diabetes/gestational diabetes
- Multiple gestation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Left Ventricular Function
Time frame: 3 months
Endothelial Function
Time frame: 3 months
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 4 Aug 2016.
- Results publication: PubMed 21943052Tyldum EV, Backe B, Stoylen A, Slordahl SA. Maternal left ventricular and endothelial functions in preeclampsia. Acta Obstet Gynecol Scand. 2012 May;91(5):566-73. doi: 10.1111/j.1600-0412.2011.01282.x.
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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.
Stig A Slørdahl, Professor study chair
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preeclampsia, run by Norwegian University of Science and Technology at 1 site in Norway.
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 4 Aug 2016. 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 Norway. 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?
Left Ventricular Function (time frame: 3 months). The study lists 2 primary outcomes in all. 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 NCT00201500, 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 4 Aug 2016.