PreeclampsiaNCT04825145
Preeclampsia and Contact Activation
An observational study of Preeclampsia and CAS, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
Preeclampsia (PE) affects approximately 5% of all pregnancies with 2,500 cases registered annually in Denmark. PE is characterized by incomplete modelling of the spiral arteries of the uterus, hypertension, inflammation, hypercoagulability and proteinuria. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preeclampsia, CAS, Misfolding Disease, Protein
- What is being tested?
- Pregnancy
- How many people
- 234 participants
- Where
- 1 siteDenmark
- Study dates
- 20 Jan 2020to 30 Nov 2021
- 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
- Adult, Older adult
Study population: Preeclamptic women anytime of pregnancy compared to healthy pregnant women (control) at the same gestational age, with matching BMI and age.
Who may be able to join
- Pregnant women developing preeclampsia
Who cannot join
- Healthy pregnant women
Trial locations and contacts
1 site in 1 country.
Denmark1 site
The Unit for Thrombosis Research, University of Southern Denmark
Esbjerg, 6700
About this study
Preeclampsia (PE) affects approximately 5% of all pregnancies with 2,500 cases registered annually in Denmark. PE is characterized by incomplete modelling of the spiral arteries of the uterus, hypertension, inflammation, hypercoagulability and proteinuria. Neonatal complications and increased cardiovascular risk are common features of the syndrome.
PE shares pathophysiologic features with recognized protein misfolding disorders and misfolded proteins are present in urine from women with PE. Misfolded proteins are potent activators of the contact system (CAS) which is involved in inflammation, coagulation and fibrinolysis.
Read more
Plasminogen activator inhibitor 2 (PAI-2) regulates important fibrinolytic processes in the placenta. The oxidative milieu characterizing PE may trigger misfolding of PAI-2 which then loose inhibitory capacity, but gain CAS-activating capacity. Thus, misfolding of PAI-2 may affect the fibrinolytic system in the placenta and compromise the modelling of the spiral arteries. Moreover, misfolded PAI-2 may contribute to the hypercoagulability and the inflammatory conditions characterizing women with PE.
The aim of the present study is i) to characterize CAS in women with PE, ii) to study the CAS-activating capacity of misfolded PAI-2 and iii) to develop and apply immunochemical methods for determination of native and misfolded PAI-2 in plasma.
- Conditions
- Preeclampsia, CAS, Misfolding Disease, Protein
- Being tested
- Pregnancy
- Keywords
- Contact activation system, PAI-2
- Medical subject headings
- Pre-Eclampsia, Proteostasis Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregnancyOther
Pregnancies complicated by preeclampsia
| Study group | Role | What they receive |
|---|---|---|
| Preeclamptic women | Pregnant women who is diagnosed with preeclampsia during anytime of pregnancy. Receives: Other: Pregnancy | |
| Healthy pregnant women | Pregnant women without preeclampsia. Will be matched for body mass index, gestational age and age. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Contact Activation System (CAS)
Biomarkers for the CAS in plasma Coagulation factor XII antigen/activity, High molecular weight kininogen (HK), Truncated (HK), Prekallikrein antigen, kallikrein generation, C1-esterase inhibitor, alpha-2-macroglobulin, Fast form alpha-2-macroglobulin, Thrombin generation,
Measured: 3 years
Misfolded Plasminogen activator inhibitor 2 (PAI-2)
Biomarkers for misfolded PAI-2 in plasma Native PAI-2 antigen, Misfolded PAI-2, Native PAI-1 antigen,
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start20 Jan 2020
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
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.
- More trials run by University of Southern DenmarkThe 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
- Cross-sectional
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Region of Southern Denmark, OPEN, Lida og Oskar Nielsens Fond, Esbjerg Fonden, Gangsted Fonden
- Responsible party
- Principal investigator, Anne Cathrine Meldgaard Godtfredsen, University of Southern Denmark
- Investigators
- Jørgen B Gram, Professor, Study director, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04825145
- Sponsor's protocol ID
- s-20190142
- Status last verified
- Nov 2022
- First submitted
- 25 Mar 2021
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Godtfredsen AC, Palarasah Y, Dolleris BB, Jorgensen JS, Sidelmann JJ, Gram JB. Increased contact activated endogenous thrombin potential in pregnant women with preeclampsia. Blood Coagul Fibrinolysis. 2024 Jan 1;35(1):1-7. doi: 10.1097/MBC.0000000000001269. Epub 2023 Nov 30.
PubMed 38051647
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preeclampsia and Contact Activation
- ClinicalTrials.gov ID
- NCT04825145
- Acronym / sponsor ID
- s-20190142
- Conditions
- Preeclampsia, CAS, Misfolding Disease, Protein
- Keywords
- Contact activation system, PAI-2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Region of Southern Denmark, OPEN, Lida og Oskar Nielsens Fond, Esbjerg Fonden, Gangsted Fonden
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 1 Apr 2021 (actual)
- 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.
Preeclampsia (PE) affects approximately 5% of all pregnancies with 2,500 cases registered annually in Denmark. PE is characterized by incomplete modelling of the spiral arteries of the uterus, hypertension, inflammation, hypercoagulability and proteinuria. Neonatal complications and increased cardiovascular risk are common features of the syndrome.
PE shares pathophysiologic features with recognized protein misfolding disorders and misfolded proteins are present in urine from women with PE. Misfolded proteins are potent activators of the contact system (CAS) which is involved in inflammation, coagulation and fibrinolysis.
Plasminogen activator inhibitor 2 (PAI-2) regulates important fibrinolytic processes in the placenta. The oxidative milieu characterizing PE may trigger misfolding of PAI-2 which then loose inhibitory capacity, but gain CAS-activating capacity. Thus, misfolding of PAI-2 may affect the fibrinolytic system in the placenta and compromise the modelling of the spiral arteries. Moreover, misfolded PAI-2 may contribute to the hypercoagulability and the inflammatory conditions characterizing women with PE.
The aim of the present study is i) to characterize CAS in women with PE, ii) to study the CAS-activating capacity of misfolded PAI-2 and iii) to develop and apply immunochemical methods for determination of native and misfolded PAI-2 in plasma.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preeclamptic women | – | Other: PregnancyPregnant women who is diagnosed with preeclampsia during anytime of pregnancy. |
| Healthy pregnant women | – | –Pregnant women without preeclampsia. Will be matched for body mass index, gestational age and age. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Preeclamptic women anytime of pregnancy compared to healthy pregnant women (control) at the same gestational age, with matching BMI and age.
Key inclusion criteria (1 listed)
- Pregnant women developing preeclampsia
Key exclusion criteria (1 listed)
- Healthy pregnant women
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 |
|---|---|---|
| PregnancyPregnancies complicated by preeclampsia | Other | Preeclamptic women |
Primary outcome
The Contact Activation System (CAS)
Time frame: 3 years
Biomarkers for the CAS in plasma Coagulation factor XII antigen/activity, High molecular weight kininogen (HK), Truncated (HK), Prekallikrein antigen, kallikrein generation, C1-esterase inhibitor, alpha-2-macroglobulin, Fast form alpha-2-macroglobulin, Thrombin generation,
Misfolded Plasminogen activator inhibitor 2 (PAI-2)
Time frame: 3 years
Biomarkers for misfolded PAI-2 in plasma Native PAI-2 antigen, Misfolded PAI-2, Native PAI-1 antigen,
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 2 Nov 2022.
- Derived from this study: PubMed 38051647Godtfredsen AC, Palarasah Y, Dolleris BB, Jorgensen JS, Sidelmann JJ, Gram JB. Increased contact activated endogenous thrombin potential in pregnant women with preeclampsia. Blood Coagul Fibrinolysis. 2024 Jan 1;35(1):1-7. doi: 10.1097/MBC.0000000000001269. Epub 2023 Nov 30.
- Individual participant dataSharing planned: Undecided
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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.
Jørgen B Gram, Professor study director
University of Southern Denmark
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 and CAS, run by University of Southern Denmark 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: finished, as of the sponsor's last update on 2 Nov 2022. 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?
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?
The Contact Activation System (CAS) (time frame: 3 years). 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 NCT04825145, 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 2 Nov 2022.