NCT00900458

Brief Summary

Primary objective:

  • To investigate whether physical exercise prior to pregnancy in formerly preeclamptic women results in a comparable improvement of vascular and endothelial functioning as in women who had an uneventful pregnancy. Secondary objectives:
  • Which cardiovascular and endothelial parameters are involved in the vascular adaptation to training in women with a history of preeclampsia.
  • To study the vascular adaptation in the (next) pregnancy in women with a history of preeclampsia compared with women with a history of an uncomplicated pregnancy, after improvement of their physical condition by exercise training. This study is important in order to get a better understanding of the vascular and endothelial factors involved in preeclampsia and the effects of training on this profile. Results of this study can contribute to the improvement of preventing hypertensive complications in pregnancy and reduction of life time risk of cardiovascular disease in formerly preeclamptic women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

May 7, 2015

Status Verified

May 1, 2015

Enrollment Period

5.8 years

First QC Date

May 11, 2009

Last Update Submit

May 6, 2015

Conditions

Preeclampsia

Keywords

preeclampsialow vs high plasma volume

Outcome Measures

Primary Outcomes (1)

  • Increase plasma volume

    3 months

Secondary Outcomes (4)

  • Venous Compliance

    3 months

  • Endothelial dysfunction

    3 months

  • Sympathetic resting activity

    3 months

  • Splanchnic blood flow

    3 months

Study Arms (3)

1

ACTIVE COMPARATOR

formerly preeclamptic women with low plasma volume

Behavioral: Aerobic Exercise training

2

ACTIVE COMPARATOR

formerly preeclamptic women with normal plasma volume

Behavioral: Aerobic Exercise training

3

OTHER

Healthy controls

Behavioral: Aerobic Exercise training

Interventions

Aerobic Exercise trainingBEHAVIORAL

aerobic exercise training (cycling)

123

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • patients: formerly preeclamptic women with history of preeclampsia (according to set criteria)
  • controls: women with history of an uneventful pregnancy All women are examined at least 5 months postpartum;

You may not qualify if:

  • pregnancy
  • insulin dependant diabetes mellitus
  • use of medication known to interfere with cardiovascular system
  • incapability to cope with physical exercise
  • auto immune disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Medical Center

Nijmegen, 6500HB, Netherlands

Location

Related Publications (3)

  • Scholten RR, Hopman MT, Lotgering FK, Spaanderman ME. Aerobic Exercise Training in Formerly Preeclamptic Women: Effects on Venous Reserve. Hypertension. 2015 Nov;66(5):1058-65. doi: 10.1161/HYPERTENSIONAHA.115.05786. Epub 2015 Sep 8.

    PMID: 26351026DERIVED

  • Scholten RR, Spaanderman ME, Green DJ, Hopman MT, Thijssen DH. Retrograde shear rate in formerly preeclamptic and healthy women before and after exercise training: relationship with endothelial function. Am J Physiol Heart Circ Physiol. 2014 Aug 1;307(3):H418-25. doi: 10.1152/ajpheart.00128.2014. Epub 2014 Jun 6.

    PMID: 24906915DERIVED

  • Scholten RR, Thijssen DJ, Lotgering FK, Hopman MT, Spaanderman ME. Cardiovascular effects of aerobic exercise training in formerly preeclamptic women and healthy parous control subjects. Am J Obstet Gynecol. 2014 Nov;211(5):516.e1-516.e11. doi: 10.1016/j.ajog.2014.04.025. Epub 2014 Apr 23.

    PMID: 24769012DERIVED

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

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

Study Officials

  • Marc Spaanderman, Dr

    Radboud University Medical Center Nijmegen

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Drs

Study Record Dates

First Submitted

May 11, 2009

First Posted

May 12, 2009

Study Start

March 1, 2009

Primary Completion

January 1, 2015

Study Completion

April 1, 2015

Last Updated

May 7, 2015

Record last verified: 2015-05

Locations

NL(1)