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

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ClinicalTrials.gov Identifier: NCT00117546
Recruitment Status : Unknown
Verified July 2007 by Radboud University.
Recruitment status was:  Recruiting
First Posted : July 7, 2005
Last Update Posted : June 8, 2010
Sponsor:
Information provided by:
Radboud University

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.

Condition or disease Intervention/treatment Phase
Preeclampsia Drug: alpha methyldopa Phase 4

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  (Clinical Trial)
Estimated Enrollment : 35 participants
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)
Study Start Date : September 2005
Estimated Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Drug: alpha methyldopa
    500 mg twice a day
    Other Name: Aldomet


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

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


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

Inclusion Criteria:

  • Primiparous
  • History of preeclampsia
  • Low plasma volume

Exclusion Criteria:

  • Thrombophilia
  • Hypertension
  • Auto-immune disorder
  • Insulin dependent diabetes mellitus

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


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

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

ClinicalTrials.gov Identifier: NCT00117546     History of Changes
Other Study ID Numbers: 2004-155
P05.0007L
First Posted: July 7, 2005    Key Record Dates
Last Update Posted: June 8, 2010
Last Verified: July 2007

Keywords provided by Radboud University:
CAPACITY trial
preeclampsia
plasma volume
sympathetic activity
hypertension
cardiovascular system

Additional relevant MeSH terms:
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Methyldopa
Antihypertensive Agents
Sympatholytics
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