PreeclampsiaNCT02691364
Different Regulation of Immune Cells in Patients With Preeclampsia
An observational study of Preeclampsia and Pregnancy, run by University Medical Center Groningen.
Trial summary
Adaptation of the maternal immune system to accommodate the semi-allogeneic fetus is necessary for pregnancy success. Dysregulation of this immune adaptation is implicated in reproductive disorders as infertility, recurrent miscarriage, fetal growth restriction, and preeclampsia. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Preeclampsia, Pregnancy
- What is being tested?
- Blood withdrawal
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Jun 2017
- 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
- No healthy volunteers
- Adult
Study population: Pregnant women with and without preeclampsia
Who may be able to join
- healthy
- written informed consent
- 18-40 years
Who cannot join
- smoking
- immune related disorders (other than preeclampsia)
- fever / illness within the last month
- infertility
- body mass index <18 or >30
About this study
Adaptation of the maternal immune system to accommodate the semi-allogeneic fetus is necessary for pregnancy success. Dysregulation of this immune adaptation is implicated in reproductive disorders as infertility, recurrent miscarriage, fetal growth restriction, and preeclampsia. The mechanisms being responsible for fetal tolerance are not known. Several T cell subsets have been implicated in fetal tolerance. The effects of preeclampsia on memory cells are not known. The main objective of this study is to analyze the effect of preeclampsia on levels of immune cells.
- Conditions
- Preeclampsia, Pregnancy
- Being tested
- Blood withdrawal
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood withdrawalProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Healthy women Receives: Procedure: Blood withdrawal | |
| Preeclamptic | Pregnant women with preeclampsia Receives: Procedure: Blood withdrawal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cell levels
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2016 (estimated)
- Study startApr 2016
- Primary completionMay 2017 (estimated)
- Study completionJun 2017 (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 Medical Center GroningenThe 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
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jelmer Prins, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02691364
- Sponsor's protocol ID
- 2015/612
- Status last verified
- Feb 2016
- First submitted
- 22 Feb 2016
- Last updated
- 25 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Regulation of Immune Cells in Patients With Preeclampsia
- ClinicalTrials.gov ID
- NCT02691364
- Acronym / sponsor ID
- 2015/612
- Conditions
- Preeclampsia, Pregnancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 25 Feb 2016 (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.
Adaptation of the maternal immune system to accommodate the semi-allogeneic fetus is necessary for pregnancy success. Dysregulation of this immune adaptation is implicated in reproductive disorders as infertility, recurrent miscarriage, fetal growth restriction, and preeclampsia. The mechanisms being responsible for fetal tolerance are not known. Several T cell subsets have been implicated in fetal tolerance. The effects of preeclampsia on memory cells are not known. The main objective of this study is to analyze the effect of preeclampsia on levels of immune cells.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | Procedure: Blood withdrawalHealthy women |
| Preeclamptic | – | Procedure: Blood withdrawalPregnant women with preeclampsia |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women with and without preeclampsia
Key inclusion criteria (3 listed)
- healthy
- written informed consent
- 18-40 years
Key exclusion criteria (5 listed)
- smoking
- immune related disorders (other than preeclampsia)
- fever / illness within the last month
- infertility
- body mass index <18 or >30
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 |
|---|---|---|
| Blood withdrawal | Procedure or surgery | Healthy, Preeclamptic |
Primary outcome
Cell levels
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2016.
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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 and Pregnancy, run by University Medical Center Groningen.
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 5 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 25 Feb 2016. 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?
Results are not available in the source record.
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?
Cell levels (time frame: 1 year). 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 25 Feb 2016.