Restless Leg SyndromeNCT01538147
Restless Leg Syndrome and Severe Preeclampsia
An observational study of Restless Leg Syndrome and Severe Preeclampsia, run by Saint Thomas Hospital, Panama at 1 site in Panama.
Trial summary
Restless Leg Syndrome is a common but not well recognized central nervous system disorder. It is more prevalent during pregnancy and, if present before pregnancy, can develop an exacerbation of symptoms. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Restless Leg Syndrome, Severe Preeclampsia
- How many people
- 310 participants
- Where
- 1 sitePanama
- Study dates
- 1 Aug 2017to 15 Dec 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pregnant patients with severe preeclampsia (cases) and normal pregnancies at term (control).
Who may be able to join
- Gestational age between 24-34 weeks
- Severe preeclampsia
Who cannot join
- Neurological disorders (central nervous system)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between Restless Leg Syndrome and Severe Preeclampsia. A Case Control Study.
Restless Leg Syndrome is a common but not well recognized central nervous system disorder. It is more prevalent during pregnancy and, if present before pregnancy, can develop an exacerbation of symptoms. In some of the hypothesis trying to explain this syndrome, the physiopathology can also explain hypertensive disorders of pregnancy. So far, no study has been done trying to link both disorders.
- Conditions
- Restless Leg Syndrome, Severe Preeclampsia
- Keywords
- Restless Leg Syndrome, Severe Preeclampsia
- Medical subject headings
- Restless Legs Syndrome, 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 |
|---|---|---|
| Cases | Patients with Severe preeclampsia | |
| Control | Patients with normal pregnancies at term |
What is being measured
The primary outcome is the main question the study is designed to answer.
Restless Leg Syndrome
Number of patients with criteris for the diagnosis of Restless Leg Syndrome
Measured: 10 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 start1 Aug 2017
- Primary completion30 Nov 2017
- Study completion15 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Restless Leg SyndromeStudies 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 (actual)
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
- NCT01538147
- Sponsor's protocol ID
- MHST2012-02
- Status last verified
- Jan 2018
- First submitted
- 19 Feb 2012
- Last updated
- 4 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Restless Leg Syndrome and Severe Preeclampsia. A Case Control Study.
- ClinicalTrials.gov ID
- NCT01538147
- Acronym / sponsor ID
- MHST2012-02
- Conditions
- Restless Leg Syndrome, Severe Preeclampsia
- Keywords
- Restless Leg Syndrome, Severe Preeclampsia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- Saint Thomas Hospital, PanamaUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 15 Dec 2017 (actual)
- 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.
Restless Leg Syndrome is a common but not well recognized central nervous system disorder. It is more prevalent during pregnancy and, if present before pregnancy, can develop an exacerbation of symptoms. In some of the hypothesis trying to explain this syndrome, the physiopathology can also explain hypertensive disorders of pregnancy. So far, no study has been done trying to link both disorders.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | –Patients with Severe preeclampsia |
| Control | – | –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 with severe preeclampsia (cases) and normal pregnancies at term (control).
Key inclusion criteria (2 listed)
- Gestational age between 24-34 weeks
- Severe preeclampsia
Key exclusion criteria (1 listed)
- Neurological disorders (central nervous system)
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
Restless Leg Syndrome
Time frame: 10 months
Number of patients with criteris for the diagnosis of Restless Leg Syndrome
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 4 Jan 2018.
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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 Restless Leg Syndrome and Severe Preeclampsia, 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 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 4 Jan 2018. 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?
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?
Restless Leg Syndrome (time frame: 10 months). 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 4 Jan 2018.