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Restless Leg Syndrome and Severe Preeclampsia

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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

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
Restless Leg Syndrome Severe Preeclampsia

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 : August 1, 2017
Primary Completion Date : November 30, 2017
Study Completion Date : December 15, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Restless Legs
U.S. FDA Resources

Group/Cohort
Cases
Patients with Severe preeclampsia
Control
Patients with normal pregnancies at term



Primary Outcome Measures :
  1. Restless Leg Syndrome [ Time Frame: 10 months ]
    Number of patients with criteris for the diagnosis of Restless Leg Syndrome



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pregnant patients with severe preeclampsia (cases) and normal pregnancies at term (control).
Criteria

Inclusion Criteria:

  • Gestational age between 24-34 weeks
  • Severe preeclampsia

Exclusion Criteria:

  • Neurological disorders (central nervous system)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01538147


Locations
Panama
Saint Thomas Maternity Hospital
Panama, Panama
Sponsors and Collaborators
Saint Thomas Hospital, Panama
Investigators
Principal Investigator: Osvaldo A Reyes, MD Saint Thomas Hospital, Panama

Responsible Party: Osvaldo A. Reyes T., MD, Saint Thomas Hospital, Panama
ClinicalTrials.gov Identifier: NCT01538147     History of Changes
Other Study ID Numbers: MHST2012-02
First Posted: February 23, 2012    Key Record Dates
Last Update Posted: January 4, 2018
Last Verified: January 2018

Keywords provided by Osvaldo A. Reyes T., Saint Thomas Hospital, Panama:
Restless Leg Syndrome
Severe Preeclampsia

Additional relevant MeSH terms:
Syndrome
Pre-Eclampsia
Psychomotor Agitation
Restless Legs Syndrome
Disease
Pathologic Processes
Hypertension, Pregnancy-Induced
Pregnancy Complications
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Parasomnias
Mental Disorders