PreeclampsiaNCT02337049
Preeclampsia Subtypes and Surrogate Markers of CVD Risk
An observational study of Preeclampsia, run by University of Aarhus at 1 site in Denmark.
Trial summary
In order to assess surrogate markers of cardiovascular risk in subtypes of preeclampsia, we will conduct a 10-year follow-up study comparing 40 women with a history of early onset preeclampsia; 40 women with a history of late onset preeclampsia and 40 women with a history of normotensive pregnancies. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Preeclampsia
- How many people
- 120 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2014to Apr 2016
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Eligible participants delivered at the Department of Obstetrics at Randers Regional Hospital 1998-2008. Early-onset preeclampsia is defined as preeclampsia that develops before 34 weeks of gestation, whereas late-onset preeclampsia develops at or after 34 weeks of gestation.
Who may be able to join
- Women who delievered at the Department of Obstetrics at Randers Regional Hospital 1998-2008
Who cannot join
- Current pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Randers Regional Hospital
Randers, Randers NØ, 8930
Martin Christensen, MD, 004578422354, marticis@rm.dk
Martin Christensen, MD
About this study
In order to assess surrogate markers of cardiovascular risk in subtypes of preeclampsia, we will conduct a 10-year follow-up study comparing 40 women with a history of early onset preeclampsia; 40 women with a history of late onset preeclampsia and 40 women with a history of normotensive pregnancies.
Eligible participants delivered at the Department of Obstetrics at Randers Regional Hospital 1998-2008.
Early-onset preeclampsia is defined as preeclampsia that develops before 34 weeks of gestation, whereas late-onset preeclampsia develops at or after 34 weeks of gestation.
- Conditions
- Preeclampsia
- Keywords
- Preeclampsia. Cardiovascular Disease (CVD) Risk.
- Medical subject headings
- Pre-Eclampsia, Cardiovascular Diseases
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 |
|---|---|---|
| Previously early onset preeclampsia | Women with a history of early onset preeclampsia 10 years ago | |
| Previously late onset preeclampsia | Women with a history of late onset preeclampsia 10 years ago | |
| Previously normotensive pregnancy | Women with a history of normotensive pregnancies 10 years ago |
What is being measured
The primary outcome is the main question the study is designed to answer.
Echocardiographic Markers of Cardiac Strain
Measured: 10 years postpartum
Secondary outcomes (2)
Markers of arteriosclerosis and atherosclerosis
Measured: 10 years postpartum
Circulating biomarkers of cardiovascular disease.
Measured: 10 years postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2015 (estimated)
- Study startSep 2014
- Primary completionDec 2015 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Observational
- Time perspective
- Retrospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Randers Regional Hospital, Karen Elise Jensen Foundation, Central Denmark Region
- Responsible party
- Sponsor
- Investigators
- Ulla B Knudsen, Professor, Study chair, Department of Obstetrics and Gynaecology, Aarhus University HosMartin Christensen, MD, Principal investigator, Clinical Research Unit, Randers Regional HospitalCamilla S Kronborg, MD, PhD, Study director, Department of Oncology, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02337049
- Sponsor's protocol ID
- 26702017
- Status last verified
- Jan 2015
- First submitted
- 5 Jan 2015
- Last updated
- 13 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preeclampsia Subtypes and Surrogate Markers of CVD Risk
- ClinicalTrials.gov ID
- NCT02337049
- Acronym / sponsor ID
- 26702017
- Conditions
- Preeclampsia
- Keywords
- Preeclampsia. Cardiovascular Disease (CVD) Risk.
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Randers Regional Hospital, Karen Elise Jensen Foundation, Central Denmark Region
- Study start
- Sep 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 13 Jan 2015 (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.
In order to assess surrogate markers of cardiovascular risk in subtypes of preeclampsia, we will conduct a 10-year follow-up study comparing 40 women with a history of early onset preeclampsia; 40 women with a history of late onset preeclampsia and 40 women with a history of normotensive pregnancies.
Eligible participants delivered at the Department of Obstetrics at Randers Regional Hospital 1998-2008.
Early-onset preeclampsia is defined as preeclampsia that develops before 34 weeks of gestation, whereas late-onset preeclampsia develops at or after 34 weeks of gestation.
Study design
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Previously early onset preeclampsia | – | –Women with a history of early onset preeclampsia 10 years ago |
| Previously late onset preeclampsia | – | –Women with a history of late onset preeclampsia 10 years ago |
| Previously normotensive pregnancy | – | –Women with a history of normotensive pregnancies 10 years ago |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Eligible participants delivered at the Department of Obstetrics at Randers Regional Hospital 1998-2008. Early-onset preeclampsia is defined as preeclampsia that develops before 34 weeks of gestation, whereas late-onset preeclampsia develops at or after 34 weeks of gestation.
Key inclusion criteria (1 listed)
- Women who delievered at the Department of Obstetrics at Randers Regional Hospital 1998-2008
Key exclusion criteria (1 listed)
- Current pregnancy or breastfeeding
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
Echocardiographic Markers of Cardiac Strain
Time frame: 10 years postpartum
2 secondary outcomes
Markers of arteriosclerosis and atherosclerosis
Time frame: 10 years postpartum
Circulating biomarkers of cardiovascular disease.
Time frame: 10 years postpartum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2015.
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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.
Ulla B Knudsen, Professor study chair
Department of Obstetrics and Gynaecology, Aarhus University Hos
Martin Christensen, MD principal investigator
Clinical Research Unit, Randers Regional Hospital
Camilla S Kronborg, MD, PhD study director
Department of Oncology, Aarhus University Hospital
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 University of Aarhus at 1 site in Denmark.
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: status not confirmed, as of the sponsor's last update on 13 Jan 2015. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Echocardiographic Markers of Cardiac Strain (time frame: 10 years postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jan 2015.