NCT01538147

Completed

Restless Leg Syndrome and Severe Preeclampsia

Saint Thomas Hospital, Panama Source

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Other study identifiers

Sponsor study identifier

MHST2012-02

Study Type

observational

Actual enrollment (reported)

310

Locations

1 country

Sites

1

Timeline

Study Start

August 1, 2017

Actual (reported)

Primary Completion

November 30, 2017

Actual (reported)

Study Completion

December 15, 2017

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 310 participants
Study completion date: December 15, 2017
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
February 19, 2012
Actual (reported)
First Posted
February 23, 2012
Actual (reported)
Study Start
August 1, 2017
Actual (reported)
Primary Completion
November 30, 2017
Actual (reported)
Study Completion
December 15, 2017
Actual (reported)

Last Updated: January 4, 2018
Status Verified: January 2018
Last Update Submitted: January 2, 2018

Conditions

Restless Leg Syndrome Severe 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

Sponsors & Collaborators

Saint Thomas Hospital, Panama
Otherlead

Study Sites (1)

Saint Thomas Maternity Hospital

Panama City, Panama

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

Enrollment

310 participants (actual enrollment reported by the registry).

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

Actual (reported)

NCT03164304

Efficacy and Safety of 1 g Vs 2 g Per Hour Intravenous Maintenance Dose of MgSO4 in Women With Severe Pre-eclampsia

Phase 4Completed

NCT03337529

Restless Legs Syndrome in Hemodialysis Patients

Not ApplicableCompleted

NCT04853771

The Effect of Progressive Muscle Relaxation Exercise Training Given to Pregnant Women With Restless Leg Syndrome

Not ApplicableCompleted

NCT03744988

Serum Androgen Levels as a Marker for the Severity of Preeclampsia

Unknown

NCT02826681

Randomized, Placebo-controlled Trial of Ferric Carboxymaltose in RLS Patients With Iron-deficiency Anemia

Phase 2Terminated

NCT06570941

Benefits of a Cannabidiolic Acid Topical Cream for the Treatment of Restless Leg Syndrome

Phase 1/2Unknown

Severe preeclampsia

You may not qualify if:

Neurological disorders (central nervous system)

Contact the study team to confirm eligibility.

Primary Completion

November 30, 2017

Actual (reported)

Study Completion

December 15, 2017

Actual (reported)

Last Updated

January 4, 2018

Record last verified: 2018-01

Source record

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Source: ClinicalTrials.gov.

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Registry identifier: NCT01538147
Data provider: ClinicalTrials.gov
Source updated: 2018-01-04
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:31:43 UTC

Locations

PA(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Cases

Control

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations