Back to resultsCardiovascular and Autonomic Reactivity in Women With a History of Pre-eclampsia
Primary Purpose
Preeclampsia
Status
Unknown status
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
alpha methyldopa
Sponsored by
About this trial
This is an interventional diagnostic trial for Preeclampsia focused on measuring CAPACITY trial, preeclampsia, plasma volume, sympathetic activity, hypertension, cardiovascular system
Eligibility Criteria
Inclusion Criteria: Primiparous History of preeclampsia Low plasma volume Exclusion Criteria: Thrombophilia Hypertension Auto-immune disorder Insulin dependent diabetes mellitus
Sites / Locations
- Radboud University Nijmegen Medical CenterRecruiting
Outcomes
Primary Outcome Measures
normalized plasma volume
Secondary Outcome Measures
increased orthostatic tolerance
normalized cardiovascular balance
venous capacitance
Full Information
NCT ID
NCT00117546
First Posted
June 30, 2005
Last Updated
June 7, 2010
Sponsor
Radboud University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00117546
Brief Title
Cardiovascular and Autonomic Reactivity in Women With a History of Pre-eclampsia
Official Title
Cardiovascular Performance and Autonomic Reactivity in Formerly Preeclamptic Women With a Contracted Plasma Volume (CAPACITY Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2007
Overall Recruitment Status
Unknown status
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Radboud University Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preeclampsia
Keywords
CAPACITY trial, preeclampsia, plasma volume, sympathetic activity, hypertension, cardiovascular system
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
alpha methyldopa
Other Intervention Name(s)
Aldomet
Intervention Description
500 mg twice a day
Primary Outcome Measure Information:
Title
normalized plasma volume
Time Frame
1 month
Secondary Outcome Measure Information:
Title
increased orthostatic tolerance
Time Frame
1 month
Title
normalized cardiovascular balance
Time Frame
1 month
Title
venous capacitance
Time Frame
1 month
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Primiparous
History of preeclampsia
Low plasma volume
Exclusion Criteria:
Thrombophilia
Hypertension
Auto-immune disorder
Insulin dependent diabetes mellitus
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
M.E.A Spaanderman, MD, PhD
Phone
+31 24 36 13401
Email
m.spaanderman@obgyn.umcn.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ineke Krabbendam, MD
Organizational Affiliation
Department of Obstetrics and Gynaecology, Radboud University Nijmegen Medical Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radboud University Nijmegen Medical Center
City
Nijmegen
Country
Netherlands
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Cardiovascular and Autonomic Reactivity in Women With a History of Pre-eclampsia
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