Restless Leg Syndrome and Severe Preeclampsia

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Saint Thomas Hospital, Panama
Sponsor:
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

February 19, 2012
April 7, 2013
August 2012
July 2013   (final data collection date for primary outcome measure)
Restless Leg Syndrome [ Time Frame: 10 months ] [ Designated as safety issue: No ]
Number of patients with criteris for the diagnosis of Restless Leg Syndrome
Same as current
Complete list of historical versions of study NCT01538147 on ClinicalTrials.gov Archive Site
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Restless Leg Syndrome and Severe Preeclampsia
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.

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Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

Pregnant patients with severe preeclampsia (cases) and normal pregnancies at term (control).

  • Restless Leg Syndrome
  • Severe Preeclampsia
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  • Cases
    Patients with Severe preeclampsia
  • Control
    Patients with normal pregnancies at term
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
310
August 2013
July 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Gestational age between 24-34 weeks
  • Severe preeclampsia

Exclusion Criteria:

  • Neurological disorders (central nervous system)
Female
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No
Panama
 
NCT01538147
MHST2012-02
No
Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
Saint Thomas Hospital, Panama
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Principal Investigator: Osvaldo A Reyes, MD Saint Thomas Hospital, Panama
Saint Thomas Hospital, Panama
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP