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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by Radboud University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00117546
First received: June 30, 2005
Last updated: June 7, 2010
Last verified: July 2007
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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:

U.S. FDA Resources

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.

  Eligibility

Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00117546     History of Changes
Other Study ID Numbers: 2004-155, P05.0007L
Study First Received: June 30, 2005
Last Updated: June 7, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on June 18, 2013