Trial record 6 of 9 for:
severe preeclampsia AND eclampsia | Panama
Restless Leg Syndrome and Severe Preeclampsia
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01538147 |
Recruitment Status :
Completed
First Posted : February 23, 2012
Last Update Posted : January 4, 2018
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Sponsor:
Saint Thomas Hospital, Panama
Information provided by (Responsible Party):
Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
Tracking Information | ||||
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First Submitted Date | February 19, 2012 | |||
First Posted Date | February 23, 2012 | |||
Last Update Posted Date | January 4, 2018 | |||
Actual Study Start Date | August 1, 2017 | |||
Actual Primary Completion Date | November 30, 2017 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
Restless Leg Syndrome [ Time Frame: 10 months ] Number of patients with criteris for the diagnosis of Restless Leg Syndrome
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Original Primary Outcome Measures | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures | Not Provided | |||
Original Secondary Outcome Measures | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | Restless Leg Syndrome and Severe Preeclampsia | |||
Official Title | 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. | |||
Detailed Description | Not Provided | |||
Study Type | Observational | |||
Study Design | 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). | |||
Condition |
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Intervention | Not Provided | |||
Study Groups/Cohorts |
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Publications * | Not Provided | |||
* 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 | Completed | |||
Actual Enrollment |
310 | |||
Original Estimated Enrollment | Same as current | |||
Actual Study Completion Date | December 15, 2017 | |||
Actual Primary Completion Date | November 30, 2017 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | Child, Adult, Older Adult | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Panama | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT01538147 | |||
Other Study ID Numbers | MHST2012-02 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Osvaldo A. Reyes T., Saint Thomas Hospital, Panama | |||
Study Sponsor | Saint Thomas Hospital, Panama | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | Saint Thomas Hospital, Panama | |||
Verification Date | January 2018 |