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...
Date First Received: June 30, 2005
Last Updated: July 30, 2007
Verified by: Radboud University, July 2007
Clinical Trial Phase: Phase 4 | Start Date: September 2005
Overall Status: Recruiting
Estimated Enrollment: 35
Brief Summary
Official Title: “Cardiovascular Performance and Autonomic Reactivity in Formerly Preeclamptic Women With a Contracted Plasma Volume (CAPACITY Trial)”
Condition Keyword(s):
Intervention(s):
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 Type: Interventional
Study Design: Diagnostic, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Drug: alpha methyldopa
Outcome Measures for this Clinical Trial
Primary Measures
- normalized plasma volume
- Time Frame: 1 month
- Time Frame: 1 month
Secondary Measures
- increased orthostatic tolerance
- Time Frame: 1 month
- Time Frame: 1 month
- normalized cardiovascular balance
- Time Frame: 1 month
- Time Frame: 1 month
- venous capacitance
- Time Frame: 1 month
- Time Frame: 1 month
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Primiparous
- History of preeclampsia
- Low plasma volume
Exclusion Criteria:
- Thrombophilia
- Hypertension
- Auto-immune disorder
- Insulin dependent diabetes mellitus
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: N/A
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Radboud University
Overall Clinical Trial Officials and Contacts
Ineke Krabbendam, MD Principal Investigator Department of Obstetrics and Gynaecology, Radboud University Nijmegen Medical Centre
Overall Contact: M.E.A Spaanderman, MD, PhD +31 24 36 13401 m.spaanderman@obgyn.umcn.nl
Additional Information
Information obtained from ClinicalTrials.gov on November 18, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00117546
Study ID Number: 2004-155
ClinicalTrials.gov Identifier: NCT00117546
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Clinical Trials Authorship and Review
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