Restless Leg Syndrome and Severe Preeclampsia

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2015 by Saint Thomas Hospital, Panama
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 Saint Thomas Hospital, Panama:

Primary Outcome Measures:
  • Restless Leg Syndrome [ Time Frame: 10 months ] [ Designated as safety issue: No ]
    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


Genders 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
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, see Learn About Clinical Studies.

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
Health Authority: Panama: Ministry of Health

Keywords provided by Saint Thomas Hospital, Panama:
Restless Leg Syndrome
Severe Preeclampsia

Additional relevant MeSH terms:
Restless Legs Syndrome
Psychomotor Agitation
Hypertension, Pregnancy-Induced
Mental Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Pathologic Processes
Pregnancy Complications
Psychomotor Disorders
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders processed this record on May 26, 2016