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NCT00117546 Clinical Trial

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

Preeclampsia Clinical Trial

Official title:
Cardiovascular Performance and Autonomic Reactivity in Formerly Preeclamptic Women With a Contracted Plasma Volume (CAPACITY Trial)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00117546
Other study ID # 2004-155
Secondary ID P05.0007L
Status Recruiting
Phase Phase 4
First received June 30, 2005
Last updated June 7, 2010
Start date September 2005
Est. completion date December 2008

Study information
Verified date July 2007
Source Radboud University
Contact M.E.A Spaanderman, MD, PhD
Phone +31 24 36 13401
Email m.spaanderman@obgyn.umcn.nl
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 35
Est. completion date December 2008
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

- Primiparous

- History of preeclampsia

- Low plasma volume

Exclusion Criteria:

- Thrombophilia

- Hypertension

- Auto-immune disorder

- Insulin dependent diabetes mellitus

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Drug:
• alpha methyldopa
500 mg twice a day

Locations
Country Name City State
Netherlands Radboud University Nijmegen Medical Center Nijmegen

Sponsors (1)
Lead Sponsor Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary normalized plasma volume 1 month
Secondary increased orthostatic tolerance 1 month
Secondary normalized cardiovascular balance 1 month
Secondary venous capacitance 1 month
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