Severe PreeclampsiaNCT01538121
Antiphospholipid Antibodies and Early Severe Preeclampsia.
An observational study of Severe Preeclampsia and Antiphospholipid Syndrome, run by Saint Thomas Hospital, Panama at 1 site in Panama.
Trial summary
The Antiphospholipid Syndrome is an immune disease where the presence of antibodies directed against cell membrane phospholipids (antiphospholipid antibodies) can cause an hypercoagulable state that causes thrombosis and obstetric complications (miscarriages, stillbirths). Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Severe Preeclampsia, Antiphospholipid Syndrome
- How many people
- 310 participants
- Where
- 1 sitePanama
- Study dates
- Jun 2015to Aug 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: Pregnant patients admitted for severe preeclampsia between 24-34 weeks pf gestation (cases) and normal patients in labor at term (controls).
Who may be able to join
- Gestational age between 24-34 weeks
- Diagnosis of severe preeclampsia
Who cannot join
- Known antiphospholipid syndrome.
- Known presence of antiphospholipid antibodies.
- Patients with systemic lupus erythematosus.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Antiphospholipid Antibodies and Early Severe Preeclampsia (< 34 Weeks of Gestation). A Case-Control Study.
The Antiphospholipid Syndrome is an immune disease where the presence of antibodies directed against cell membrane phospholipids (antiphospholipid antibodies) can cause an hypercoagulable state that causes thrombosis and obstetric complications (miscarriages, stillbirths). Since 1999 the Sapporo Criteria for Antiphospholipid Syndrome diagnosis includes the development of severe preeclampsia before 34 weeks of gestation, but this was done without solid evidence of a relation between the two. Our study will try to add information to this particular point.
- Conditions
- Severe Preeclampsia, Antiphospholipid Syndrome
- Keywords
- Antibodies, anticardiolipin, Antibodies, B2 Glycoprotein I, Lupus Anticoagulant, Severe Preeclampsia
- Medical subject headings
- Pre-Eclampsia, Antiphospholipid Syndrome
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 |
|---|---|---|
| Cases-Early Severe Preeclampsia | Patients with severe preeclampsia before 34 weeks of gestation | |
| Controls | Patients with normal pregnancies at term. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lupus anticoagulant
Number of cases positive for Lupus Anticoagulant.
Measured: 15 months
Anticardiolipin antibodies
Number of cases with high/medium levels of IgG/IgM of anticardiolipin antibodies.
Measured: 15 months
B2 Glycoprotein I
Number of cases with levels of B2 Glycoprotein 1 > 99%
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2012 (estimated)
- Study startJun 2015
- Primary completionJul 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe PreeclampsiaStudies 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
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint Thomas Hospital, Panama
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
- Investigators
- Osvaldo A Reyes, MD, Principal investigator, Saint Thomas Hospital, Panama
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01538121
- Sponsor's protocol ID
- MHST2012-01A
- Status last verified
- Jan 2015
- First submitted
- 19 Feb 2012
- Last updated
- 5 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antiphospholipid Antibodies and Early Severe Preeclampsia (< 34 Weeks of Gestation). A Case-Control Study.
- ClinicalTrials.gov ID
- NCT01538121
- Acronym / sponsor ID
- MHST2012-01A
- Conditions
- Severe Preeclampsia, Antiphospholipid Syndrome
- Keywords
- Antibodies, anticardiolipin, Antibodies, B2 Glycoprotein I, Lupus Anticoagulant, Severe Preeclampsia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- Saint Thomas Hospital, PanamaUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 23 Feb 2012 (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.
The Antiphospholipid Syndrome is an immune disease where the presence of antibodies directed against cell membrane phospholipids (antiphospholipid antibodies) can cause an hypercoagulable state that causes thrombosis and obstetric complications (miscarriages, stillbirths). Since 1999 the Sapporo Criteria for Antiphospholipid Syndrome diagnosis includes the development of severe preeclampsia before 34 weeks of gestation, but this was done without solid evidence of a relation between the two. Our study will try to add information to this particular point.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases-Early Severe Preeclampsia | – | –Patients with severe preeclampsia before 34 weeks of gestation |
| Controls | – | –Patients with normal pregnancies at term. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant patients admitted for severe preeclampsia between 24-34 weeks pf gestation (cases) and normal patients in labor at term (controls).
Key inclusion criteria (2 listed)
- Gestational age between 24-34 weeks
- Diagnosis of severe preeclampsia
Key exclusion criteria (3 listed)
- Known antiphospholipid syndrome.
- Known presence of antiphospholipid antibodies.
- Patients with systemic lupus erythematosus.
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
Lupus anticoagulant
Time frame: 15 months
Number of cases positive for Lupus Anticoagulant.
Anticardiolipin antibodies
Time frame: 15 months
Number of cases with high/medium levels of IgG/IgM of anticardiolipin antibodies.
B2 Glycoprotein I
Time frame: 15 months
Number of cases with levels of B2 Glycoprotein 1 > 99%
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 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.
Osvaldo A Reyes, MD principal investigator
Saint Thomas Hospital, Panama
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 Severe Preeclampsia and Antiphospholipid Syndrome, run by Saint Thomas Hospital, Panama at 1 site in Panama.
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 2 inclusion and 3 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 5 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 Panama. 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?
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?
Lupus anticoagulant (time frame: 15 months). The study lists 3 primary outcomes in all. 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 5 Jan 2015.