Restless Leg Syndrome and Severe Preeclampsia | NCT01538147

Studies
Restless Leg Syndrome and Severe Preeclampsia

NCT01538147

Sponsor

Saint Thomas Hospital, Panama

Status

Completed

Last Update Posted

Jan 4, 2018Actual

Enrollment

310Actual

Phase

Not provided

Conditions

Restless Leg Syndrome
Severe Preeclampsia

Interventions

Not provided

Countries

Panama

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2017Actual

Primary Completion Date

Nov 30, 2017Actual

Completion Date

Dec 15, 2017Actual

First Submitted Date

Feb 19, 2012

First Submission Date that Met QC Criteria

Feb 22, 2012

First Posted Date

Feb 23, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 2, 2018

Last Update Posted Date

Jan 4, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

310Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cases		Patients with Severe preeclampsia
Control		Patients with normal pregnancies at term

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Gestational age between 24-34 weeks
Severe preeclampsia

Exclusion Criteria:

Neurological disorders (central nervous system)

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Osvaldo A Reyes, MD	Saint Thomas Hospital, Panama	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Saint Thomas Maternity Hospital		Panama City			Panama

Condition Browse Module

MeSH Terms

ID	Term
D012148	Restless Legs Syndrome
D011225	Pre-Eclampsia

Ancestor Terms

ID	Term
D009422	Nervous System Diseases
D020919	Sleep Disorders, Intrinsic
D020920	Dyssomnias
D012893	Sleep Wake Disorders

Browse Leaves

Not provided

Browse Branches

Not provided