Restless Leg Syndrome and Severe Preeclampsia

January 2, 2018 updated by: Osvaldo A. Reyes T., Saint Thomas Hospital, Panama

Association Between Restless Leg Syndrome and Severe Preeclampsia. A Case Control Study.

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

310

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Panama
      • Panama, Panama
        • Saint Thomas Maternity Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant patients with severe preeclampsia (cases) and normal pregnancies at term (control).

Description

Inclusion Criteria:

  • Gestational age between 24-34 weeks
  • Severe preeclampsia

Exclusion Criteria:

  • Neurological disorders (central nervous system)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Restless Leg Syndrome
Time Frame: 10 months
Number of patients with criteris for the diagnosis of Restless Leg Syndrome
10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saint Thomas Hospital, Panama

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2017

Primary Completion (Actual)

November 30, 2017

Study Completion (Actual)

December 15, 2017

Study Registration Dates

First Submitted

February 19, 2012

First Submitted That Met QC Criteria

February 22, 2012

First Posted (Estimate)

February 23, 2012

Study Record Updates

Last Update Posted (Actual)

January 4, 2018

Last Update Submitted That Met QC Criteria

January 2, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MHST2012-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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