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Restless Leg Syndrome and Severe Preeclampsia

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2015 by Osvaldo A. Reyes T., Saint Thomas Hospital, Panama.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Osvaldo A. Reyes T., Saint Thomas Hospital, Panama Identifier:
First received: February 19, 2012
Last updated: January 1, 2015
Last verified: January 2015
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.

Restless Leg Syndrome
Severe Preeclampsia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Association Between Restless Leg Syndrome and Severe Preeclampsia. A Case Control Study.

Resource links provided by NLM:

Further study details as provided by Osvaldo A. Reyes T., Saint Thomas Hospital, Panama:

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

Estimated Enrollment: 310
Study Start Date: August 2014
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Patients with Severe preeclampsia
Patients with normal pregnancies at term


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).

Inclusion Criteria:

  • Gestational age between 24-34 weeks
  • Severe preeclampsia

Exclusion Criteria:

  • Neurological disorders (central nervous system)
  Contacts and Locations
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Please refer to this study by its identifier: NCT01538147

Saint Thomas Maternity Hospital Recruiting
Panama, Panama
Contact: Osvaldo A Reyes, MD (Gyn/Ob)    011(507)65655041   
Contact: Gerardo Cárdenas, MD (Gyn/Ob)         
Principal Investigator: Osvaldo A Reyes, MD (Gyn/Ob)         
Sponsors and Collaborators
Saint Thomas Hospital, Panama
Principal Investigator: Osvaldo A Reyes, MD Saint Thomas Hospital, Panama
  More Information

Responsible Party: Osvaldo A. Reyes T., MD, Saint Thomas Hospital, Panama Identifier: NCT01538147     History of Changes
Other Study ID Numbers: MHST2012-02
Study First Received: February 19, 2012
Last Updated: January 1, 2015

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

Additional relevant MeSH terms:
Restless Legs Syndrome
Psychomotor Agitation
Pathologic Processes
Hypertension, Pregnancy-Induced
Pregnancy Complications
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Mental Disorders processed this record on May 25, 2017