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Restless Leg Syndrome and Severe Preeclampsia

Sponsor
Saint Thomas Hospital, Panama (Other)
Overall Status
Completed
CT.gov ID
NCT01538147
Collaborator
(none)
310
Enrollment
1
Location
4.5
Actual Duration (Months)
69.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    310 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Association Between Restless Leg Syndrome and Severe Preeclampsia. A Case Control Study.
    Actual Study Start Date :
    Aug 1, 2017
    Actual Primary Completion Date :
    Nov 30, 2017
    Actual Study Completion Date :
    Dec 15, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    Cases

    Patients with Severe preeclampsia
    Control

    Patients with normal pregnancies at term

    Outcome Measures

    Primary Outcome Measures

    1. Restless Leg Syndrome [10 months]

      Number of patients with criteris for the diagnosis of Restless Leg Syndrome

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Gestational age between 24-34 weeks

    • Severe preeclampsia

    Exclusion Criteria:
    • Neurological disorders (central nervous system)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Saint Thomas Maternity Hospital Panama Panama

    Sponsors and Collaborators

    • Saint Thomas Hospital, Panama

    Investigators

    • Principal Investigator: Osvaldo A Reyes, MD, Saint Thomas Hospital, Panama

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Osvaldo A. Reyes T., MD, Saint Thomas Hospital, Panama
    ClinicalTrials.gov Identifier:
    NCT01538147
    Other Study ID Numbers:
    • MHST2012-02
    First Posted:
    Feb 23, 2012
    Last Update Posted:
    Jan 4, 2018
    Last Verified:
    Jan 1, 2018
    Keywords provided by Osvaldo A. Reyes T., MD, Saint Thomas Hospital, Panama
    Restless Leg Syndrome
    Severe Preeclampsia
    Additional relevant MeSH terms:
    Psychomotor Agitation
    Restless Legs Syndrome
    Pre-Eclampsia
    Syndrome

    Study Results

    No Results Posted as of Jan 4, 2018