Restless Leg Syndrome and Severe Preeclampsia

• ClinicalTrials.gov Identifier: NCT01538147
• Recruitment Status: Completed
• First Posted: February 23, 2012
• Last Update Posted: January 4, 2018
• Sponsor: Saint Thomas Hospital, Panama
• Information provided by (Responsible Party): Osvaldo A. Reyes T., Saint Thomas Hospital, Panama

Tracking Information

• First Submitted Date: February 19, 2012
• First Posted Date: February 23, 2012
• Last Update Posted Date: January 4, 2018
• Actual Study Start Date: August 1, 2017
• Actual Primary Completion Date: November 30, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 22, 2012)

Restless Leg Syndrome [ Time Frame: 10 months ]

Number of patients with criteris for the diagnosis of Restless Leg Syndrome

• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT01538147 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Restless Leg Syndrome and Severe Preeclampsia
• Official Title: Association Between Restless Leg Syndrome and Severe Preeclampsia. A Case Control Study.
• 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.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Case-Control; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Pregnant patients with severe preeclampsia (cases) and normal pregnancies at term (control).

Condition

• Restless Leg Syndrome
• Severe Preeclampsia

• Intervention: Not Provided

Study Groups/Cohorts

• Cases
  Patients with Severe preeclampsia
• Control
  Patients with normal pregnancies at term

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 22, 2012): 310
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: December 15, 2017
• Actual Primary Completion Date: November 30, 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Gestational age between 24-34 weeks
• Severe preeclampsia

Exclusion Criteria:

• Neurological disorders (central nervous system)

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Panama

Administrative Information

• NCT Number: NCT01538147
• Other Study ID Numbers: MHST2012-02
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
• Study Sponsor: Saint Thomas Hospital, Panama
• Collaborators: Not Provided

Investigators

• Principal Investigator: Osvaldo A Reyes, MD; Saint Thomas Hospital, Panama

• PRS Account: Saint Thomas Hospital, Panama
• Verification Date: January 2018