Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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
Actual Primary Completion Date : November 30, 2017
Actual Study Completion Date : December 15, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Restless Legs

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
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)
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location information
Panama
Saint Thomas Maternity Hospital
Panama, Panama
Sponsors and Collaborators
Saint Thomas Hospital, Panama
Investigators
Layout table for investigator information
Principal Investigator: Osvaldo A Reyes, MD Saint Thomas Hospital, Panama
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for additonal information
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:
Layout table for MeSH terms
Psychomotor Agitation
Restless Legs Syndrome
Pre-Eclampsia
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