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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2007 by Radboud University.
Recruitment status was:  Recruiting
ClinicalTrials.gov Identifier:
First Posted: July 7, 2005
Last Update Posted: June 8, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Radboud University
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.

Condition Intervention Phase
Preeclampsia Drug: alpha methyldopa Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Diagnostic
Official Title: Cardiovascular Performance and Autonomic Reactivity in Formerly Preeclamptic Women With a Contracted Plasma Volume (CAPACITY Trial)

Resource links provided by NLM:

Further study details as provided by Radboud University:

Primary Outcome Measures:
  • normalized plasma volume [ Time Frame: 1 month ]

Secondary Outcome Measures:
  • increased orthostatic tolerance [ Time Frame: 1 month ]
  • normalized cardiovascular balance [ Time Frame: 1 month ]
  • venous capacitance [ Time Frame: 1 month ]

Estimated Enrollment: 35
Study Start Date: September 2005
Estimated Study Completion Date: December 2008
Intervention Details:
    Drug: alpha methyldopa
    500 mg twice a day
    Other Name: Aldomet
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.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Primiparous
  • History of preeclampsia
  • Low plasma volume

Exclusion Criteria:

  • Thrombophilia
  • Hypertension
  • Auto-immune disorder
  • Insulin dependent diabetes mellitus
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00117546

Contact: M.E.A Spaanderman, MD, PhD +31 24 36 13401 m.spaanderman@obgyn.umcn.nl

Radboud University Nijmegen Medical Center Recruiting
Nijmegen, Netherlands
Sponsors and Collaborators
Radboud University
Principal Investigator: Ineke Krabbendam, MD Department of Obstetrics and Gynaecology, Radboud University Nijmegen Medical Centre
  More Information

ClinicalTrials.gov Identifier: NCT00117546     History of Changes
Other Study ID Numbers: 2004-155
First Submitted: June 30, 2005
First Posted: July 7, 2005
Last Update Posted: June 8, 2010
Last Verified: July 2007

Keywords provided by Radboud University:
plasma volume
sympathetic activity
cardiovascular system

Additional relevant MeSH terms:
Hypertension, Pregnancy-Induced
Pregnancy Complications
Antihypertensive Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

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