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

June 7, 2010 updated by: Radboud University Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Preeclampsia

Intervention / Treatment

Drug: alpha methyldopa

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.

Study Type

Interventional

Enrollment (Anticipated)

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Netherlands
- - Nijmegen, Netherlands
    - Recruiting
    - Radboud University Nijmegen Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Primiparous
History of preeclampsia
Low plasma volume

Exclusion Criteria:

Thrombophilia
Hypertension
Auto-immune disorder
Insulin dependent diabetes mellitus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Interventional Model: Crossover Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
normalized plasma volume Time Frame: 1 month	1 month

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Study Completion (Anticipated)

December 1, 2008

Study Registration Dates

First Submitted

June 30, 2005

First Submitted That Met QC Criteria