Pre-EclampsiaNCT00215969
Prospective Study in Pregnant Women With Hypercoagulopathy
An observational study of Pre-Eclampsia and Eclampsia, run by Hillerod Hospital, Denmark at 2 sites in Denmark.
Trial summary
Pre-eclampsia is one of the most common causes of maternal and fetal morbidity and mortality. The aim of this study is to identify pregnant women at risk for pre-eclampsia or other cardiovascular complications at a very early state of the disease, and thereby improve the current method of screening. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pre-Eclampsia, Eclampsia
- How many people
- 600 participants
- Where
- 2 sitesDenmark
- Study dates
- Jan 2004to Oct 2007
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant women attending the midwife at Hilleroed Hospital, Frederiksborg County, Denmark.
Who cannot join
- Mental disease.
- Problems understanding or reading Danish.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites, 2 recruiting
- Recruiting
Department of Gynaecology and Obstetrics, Hilleroed Hospital
Hilleroed, Frederiksborg County, 3400
Jørgen G Berthelsen, MD, +45 4829 3707, jgb@dadlnet.dk
Anita S Andersen, MD
- Recruiting
Department of Gynaecology and Obstetrics
Hilleroed, Frederiksborg, 3400
Jørgen G Berthelsen, MD, 4829 3707, jgb@dadlnet.dk
About this study
Official title: Prospective Study of Hypercoagulation in Pregnant Women
Pre-eclampsia is one of the most common causes of maternal and fetal morbidity and mortality. The aim of this study is to identify pregnant women at risk for pre-eclampsia or other cardiovascular complications at a very early state of the disease, and thereby improve the current method of screening.
Read the detailed description
600 pregnant women will be included in the project and followed in a standardized manner during their pregnancy. On a regular basis blood- and urine samples will be taken throughout their pregnancy and until 1 month after delivery and analyzed for a large variety of coagulation factors in order to identify factors that might predict an increased risk of developing pre-eclampsia and/or cardiovascular events. In addition a DNA-sample is taken if consented in order to evaluate genetic factors.
- Conditions
- Pre-Eclampsia, Eclampsia
- Keywords
- Pre-eclampsia, Pregnancy, Hypercoagulation, Screening, Cardiovascular complications
- Medical subject headings
- Pre-Eclampsia, Eclampsia, Thrombophilia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJan 2004
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-EclampsiaStudies 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
- Time perspective
- Prospective
- Enrolment
- 600 participants
Sponsor and investigators
- Lead sponsor
- Hillerod Hospital, Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Clinical Trials, Denmark, Loyola University
- Investigators
- Anita S Andersen, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00215969
- Sponsor's protocol ID
- PR0104
- Status last verified
- Sep 2005
- First submitted
- 14 Sep 2005
- Last updated
- 2 Feb 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Hypercoagulation in Pregnant Women
- ClinicalTrials.gov ID
- NCT00215969
- Acronym / sponsor ID
- PR0104
- Conditions
- Pre-Eclampsia, Eclampsia
- Keywords
- Pre-eclampsia, Pregnancy, Hypercoagulation, Screening, Cardiovascular complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants
- Lead sponsor
- Hillerod Hospital, DenmarkUniversity, hospital or other
- Collaborators
- Department of Clinical Trials, Denmark, Loyola University
- Study start
- Jan 2004
- Study completion
- Oct 2007
- First posted
- 22 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.
Pre-eclampsia is one of the most common causes of maternal and fetal morbidity and mortality. The aim of this study is to identify pregnant women at risk for pre-eclampsia or other cardiovascular complications at a very early state of the disease, and thereby improve the current method of screening.
Detailed description
600 pregnant women will be included in the project and followed in a standardized manner during their pregnancy. On a regular basis blood- and urine samples will be taken throughout their pregnancy and until 1 month after delivery and analyzed for a large variety of coagulation factors in order to identify factors that might predict an increased risk of developing pre-eclampsia and/or cardiovascular events. In addition a DNA-sample is taken if consented in order to evaluate genetic factors.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Pregnant women attending the midwife at Hilleroed Hospital, Frederiksborg County, Denmark.
Key exclusion criteria (2 listed)
- Mental disease.
- Problems understanding or reading Danish.
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2006.
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Preeclampsia
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The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
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Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
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Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
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.
Anita S Andersen, MD principal investigator
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pre-Eclampsia and Eclampsia, run by Hillerod Hospital, Denmark at 2 sites 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 2 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 2 Feb 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Contact Anita S Andersen, MD (+45 4829 6828, asan@fa.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 2 Feb 2006.