Cardiovascular and Autonomic Reactivity in Women With a H... | NCT00117546

Studies
Cardiovascular and Autonomic Reactivity in Women With a History of Pre-eclampsia

NCT00117546

Sponsor

Radboud University Medical Center

Status

Unknown status

Last Update Posted

Jun 8, 2010Estimated

Enrollment

35Estimated

Phase

Phase 4

Conditions

Preeclampsia

Interventions

alpha methyldopa

Countries

Netherlands

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

ID	Type	Description	Link
P05.0007L

Status Module

Record Verification Date

Jul 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2005

Primary Completion Date

Not provided

Completion Date

Dec 2008Estimated

First Submitted Date

Jun 30, 2005

First Submission Date that Met QC Criteria

Jun 30, 2005

First Posted Date

Jul 7, 2005Estimated

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

Jun 7, 2010

Last Update Posted Date

Jun 8, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

A history of preeclampsia is associated with a low plasma volume and higher sympathetic activity. Methyldopa will suppress sympathetic activity to normal values. In this study, the researchers will test that effect on the total cardiovascular balance.

Detailed Description

This is a randomized double-blind placebo controlled cross-over study in formerly preeclamptic women with a contracted plasma volume. The researchers will test the effect of methyldopa on the cardiovascular balance and orthostatic tolerance in women with a history of preeclampsia and healthy controls.

Design Module

Study Type

Interventional

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Estimated

Name	Type	Description	Arm Group Labels	Other Names
alpha methyldopa	Drug	500 mg twice a day		Aldomet

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
normalized plasma volume		1 month

Secondary Outcomes

Measure	Description	Time Frame
increased orthostatic tolerance		1 month
normalized cardiovascular balance		1 month
venous capacitance

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Primiparous
History of preeclampsia
Low plasma volume

Exclusion Criteria:

Thrombophilia
Hypertension
Auto-immune disorder
Insulin dependent diabetes mellitus

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
M.E.A Spaanderman, MD, PhD	Contact	+31 24 36 13401		m.spaanderman@obgyn.umcn.nl

Overall Officials

Name	Affiliation	Role
Ineke Krabbendam, MD	Department of Obstetrics and Gynaecology, Radboud University Nijmegen Medical Centre	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Radboud University Nijmegen Medical Center	Recruiting	Nijmegen			Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D011225	Pre-Eclampsia
D006973	Hypertension

Ancestor Terms

ID	Term
D046110	Hypertension, Pregnancy-Induced
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008750	Methyldopa

Ancestor Terms

ID	Term
D004295	Dihydroxyphenylalanine
D002395	Catecholamines
D000588	Amines
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided