NCT00117546

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2005

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 7, 2005

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2005

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

June 8, 2010

Status Verified

July 1, 2007

First QC Date

June 30, 2005

Last Update Submit

June 7, 2010

Conditions

Preeclampsia

Keywords

CAPACITY trialpreeclampsiaplasma volumesympathetic activityhypertensioncardiovascular system

Outcome Measures

Primary Outcomes (1)

  • normalized plasma volume

    1 month

Secondary Outcomes (3)

  • increased orthostatic tolerance

    1 month

  • normalized cardiovascular balance

    1 month

  • venous capacitance

    1 month

Interventions

alpha methyldopaDRUG

500 mg twice a day

Also known as: Aldomet

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Primiparous
  • History of preeclampsia
  • Low plasma volume

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Nijmegen Medical Center

Nijmegen, Netherlands

RECRUITING

MeSH Terms

Conditions

Pre-EclampsiaHypertension

Interventions

Methyldopa

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

DihydroxyphenylalanineCatecholaminesAminesOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsTyrosine

Study Officials

  • Ineke Krabbendam, MD

    Department of Obstetrics and Gynaecology, Radboud University Nijmegen Medical Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

M.E.A Spaanderman, MD, PhD

CONTACT

+31 24 36 13401m.spaanderman@obgyn.umcn.nl

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 30, 2005

First Posted

July 7, 2005

Study Start

September 1, 2005

Study Completion

December 1, 2008

Last Updated

June 8, 2010

Record last verified: 2007-07

Locations

NL(1)