PreeclampsiaNCT01385813
Inflammatory Markers in Preeclampsia
An observational study of Preeclampsia, run by Oslo University Hospital.
Trial summary
This is an investigation of inflammatory markers in women destined to develop preeclampsia. Read more about this study
- Who is it for?
- Ages 20 to 43 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia
- How many people
- 129 participants
- Where
- No sites listed yet
- Study dates
- Jan 1999to May 2004
- 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 20 to 43 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The study comprised 43 pregnant women who developed preeclampsia and 86 pregnant women who fulfilled a normotensive pregnancy. All women were of Caucasian origin, and were nulliparous.
Who may be able to join
- Caucasian origin
Who cannot join
- Previous diseases e.g. cardiovascular disease, diabetes, hypertension, inflammatory bowel disease, serious organ disease
About this study
This is an investigation of inflammatory markers in women destined to develop preeclampsia.
- Conditions
- Preeclampsia
- Keywords
- pre-eclampsia, inflammatory markers, serological biobank, To assess whether the inflammatory markers could be useful, in order to identify pregnant women at risk to, develop 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 |
|---|---|---|
| Pregnant women who develop preeclampsia | pregnant women who develop preeclampsia (n =43) compared to pregnant women fulfilling a normotensive pregnancy (n= 86). |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2011 (estimated)
- Study startJan 1999
- Primary completionMay 2004
- Study completionMay 2004
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 Oslo University HospitalThe 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
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01385813
- Sponsor's protocol ID
- INFLAMMARPE11
- Status last verified
- May 2011
- First submitted
- 29 Jun 2011
- Last updated
- 18 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Markers in Preeclampsia
- ClinicalTrials.gov ID
- NCT01385813
- Acronym / sponsor ID
- INFLAMMARPE11
- Conditions
- Preeclampsia
- Keywords
- pre-eclampsia, inflammatory markers, serological biobank, To assess whether the inflammatory markers could be useful, in order to identify pregnant women at risk to, develop preeclampsia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Jan 1999
- Primary completion
- May 2004 (actual)
- Study completion
- May 2004 (actual)
- First posted
- 30 Jun 2011 (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 an investigation of inflammatory markers in women destined to develop preeclampsia.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women who develop preeclampsia | – | –pregnant women who develop preeclampsia (n =43) compared to pregnant women fulfilling a normotensive pregnancy (n= 86). |
Who may qualify
- Ages
- 20 to 43 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study comprised 43 pregnant women who developed preeclampsia and 86 pregnant women who fulfilled a normotensive pregnancy. All women were of Caucasian origin, and were nulliparous.
Key inclusion criteria (1 listed)
- Caucasian origin
Key exclusion criteria (1 listed)
- Previous diseases e.g. cardiovascular disease, diabetes, hypertension, inflammatory bowel disease, serious organ disease
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
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 18 Jul 2011.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Preeclampsia, run by Oslo University Hospital.
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 18 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
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 18 Jul 2011.