NCT01538147

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
310

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 23, 2012

Completed
5.4 years until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2017

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2017

Completed
Last Updated

January 4, 2018

Status Verified

January 1, 2018

Enrollment Period

4 months

First QC Date

February 19, 2012

Last Update Submit

January 2, 2018

Conditions

Restless Leg SyndromeSevere Preeclampsia

Keywords

Restless Leg SyndromeSevere Preeclampsia

Outcome Measures

Primary Outcomes (1)

  • Restless Leg Syndrome

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

    10 months

Study Arms (2)

Cases

Patients with Severe preeclampsia

Control

Patients with normal pregnancies at term

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Gestational age between 24-34 weeks
  • Severe preeclampsia

You may not qualify if:

  • Neurological disorders (central nervous system)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Thomas Maternity Hospital

Panama City, Panama

Location

MeSH Terms

Conditions

Restless Legs SyndromePre-Eclampsia

Condition Hierarchy (Ancestors)

Nervous System DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersParasomniasMental DisordersHypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Osvaldo A Reyes, MD

    Saint Thomas Hospital, Panama

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 19, 2012

First Posted

February 23, 2012

Study Start

August 1, 2017

Primary Completion

November 30, 2017

Study Completion

December 15, 2017

Last Updated

January 4, 2018

Record last verified: 2018-01

Locations

PA(1)