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Trial record 6 of 8 for:    severe preeclampsia AND eclampsia | Panama

Restless Leg Syndrome and Severe Preeclampsia

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
Sponsor:
Information provided by (Responsible Party):
Osvaldo A. Reyes T., Saint Thomas Hospital, Panama

Tracking Information
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
 (submitted: February 22, 2012)
Restless Leg Syndrome [ Time Frame: 10 months ]
Number of patients with criteris for the diagnosis of Restless Leg Syndrome
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01538147 on ClinicalTrials.gov Archive Site
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
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
  • Restless Leg Syndrome
  • Severe Preeclampsia
Intervention Not Provided
Study Groups/Cohorts
  • Cases
    Patients with Severe preeclampsia
  • Control
    Patients with normal pregnancies at term
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 22, 2012)
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:

  • Gestational age between 24-34 weeks
  • Severe preeclampsia

Exclusion Criteria:

  • Neurological disorders (central nervous system)
Sex/Gender
Sexes Eligible for Study: Female
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
Principal Investigator: Osvaldo A Reyes, MD Saint Thomas Hospital, Panama
PRS Account Saint Thomas Hospital, Panama
Verification Date January 2018