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Restless Leg Syndrome and Severe Preeclampsia

This study is currently recruiting participants.
Verified April 2013 by Saint Thomas Hospital, Panama
Sponsor:
Information provided by (Responsible Party):
Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
ClinicalTrials.gov Identifier:
NCT01538147
First received: February 19, 2012
Last updated: April 7, 2013
Last verified: April 2013
History of Changes
  Purpose

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
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:

U.S. FDA Resources

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 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cases
Patients with Severe preeclampsia
Control
Patients with normal pregnancies at term

  Eligibility

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).

Criteria

Inclusion Criteria:

  • Gestational age between 24-34 weeks
  • Severe preeclampsia

Exclusion Criteria:

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

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

No publications provided

Responsible Party: Osvaldo A. Reyes T., MD, Saint Thomas Hospital, Panama
ClinicalTrials.gov Identifier: NCT01538147     History of Changes
Other Study ID Numbers: MHST2012-02
Study First Received: February 19, 2012
Last Updated: April 7, 2013
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
Pre-Eclampsia
Psychomotor Agitation
Hypertension, Pregnancy-Induced
Pregnancy Complications
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
 Nervous System Diseases
Parasomnias
Mental Disorders
Dyskinesias
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013