Restless Leg Syndrome and Severe Preeclampsia
This study is currently recruiting participants.
Verified April 2013 by Saint Thomas Hospital, Panama
Sponsor:
Saint Thomas Hospital, Panama
Information provided by (Responsible Party):
Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
ClinicalTrials.gov Identifier:
NCT01538147
First received: February 19, 2012
Last updated: April 7, 2013
Last verified: April 2013
| Tracking Information | |||||
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| First Received Date ICMJE | February 19, 2012 | ||||
| Last Updated Date | April 7, 2013 | ||||
| Start Date ICMJE | August 2012 | ||||
| Estimated Primary Completion Date | July 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Restless Leg Syndrome [ Time Frame: 10 months ] [ Designated as safety issue: No ] Number of patients with criteris for the diagnosis of Restless Leg Syndrome |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01538147 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Restless Leg Syndrome and Severe Preeclampsia | ||||
| Official Title ICMJE | Association Between Restless Leg Syndrome and Severe Preeclampsia. A Case Control Study. | ||||
| Brief 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. 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Pregnant patients with severe preeclampsia (cases) and normal pregnancies at term (control). |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 310 | ||||
| Estimated Completion Date | August 2013 | ||||
| Estimated Primary Completion Date | July 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Not Provided | ||||
| Location Countries ICMJE | Panama | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01538147 | ||||
| Other Study ID Numbers ICMJE | MHST2012-02 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Osvaldo A. Reyes T., Saint Thomas Hospital, Panama | ||||
| Study Sponsor ICMJE | Saint Thomas Hospital, Panama | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Saint Thomas Hospital, Panama | ||||
| Verification Date | April 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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