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

Information source: Radboud University
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Preeclampsia

Intervention: alpha methyldopa (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Radboud University

Official(s) and/or principal investigator(s):
Ineke Krabbendam, MD, Principal Investigator, Affiliation: Department of Obstetrics and Gynaecology, Radboud University Nijmegen Medical Centre

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

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Diagnostic

Primary outcome: normalized plasma volume

Secondary outcome:

increased orthostatic tolerance

normalized cardiovascular balance

venous capacitance

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

Minimum age: N/A. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Primiparous

- History of preeclampsia

- Low plasma volume

Exclusion Criteria:

- Thrombophilia

- Hypertension

- Auto-immune disorder

- Insulin dependent diabetes mellitus

Locations and Contacts

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

Radboud University Nijmegen Medical Center, Nijmegen, Netherlands; Recruiting
Additional Information

Starting date: September 2005
Last updated: June 7, 2010

Page last updated: February 07, 2013

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