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
• 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

• Pre-Eclampsia
• Preeclampsia

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