Main objective:Have formerly preeclamptic women, 5 to 10 years post-partum, a higher prevalence of a cardiovascular riskprofile compared to women with uncomplicated pregancies in history.
ID
Source
Brief title
Condition
- Heart failures
- Glucose metabolism disorders (incl diabetes mellitus)
- Vascular hypertensive disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Diastolic dysfunction (echocardiographic/ NT-pro BNP)
Secondary outcome
1) Lifestyle (questionaire)
2) Metabolic syndrom or it's components (obesity, hypertension, dyslipidaemia,
insulin resistance)
3) Endothelial function (FMD)
4) Intima Media Thickness (IMT)
5) Baroreceptor sensitivity (during Head up Tilt)
6) Venous compliance
Background summary
Large retrospective studies demonstrated an increasd cardiovasculair risk in
women who had preeclampsia during one of their pregnancies, compared to women
with uncomplicated pregnancies. The exact pathway for this risk relation
between preeclampsia nad remote cardiovascular disease remains to be
elucidated. Even though preeclampsia is known to initiate endothelial damage,
it is considered to be more likely that preeclampsia and cardiovascular disease
have common underlying riskfactors. The metabolic syndrome, or its components
is possibly an important underlying profile. For most riskfactors are well
proven effective preventative strategies.
Current knowledge is mostly based on retrospective studies in women with
diagnosed cardiovascular disease. Structured case-control studies would give
more insight into the possible underlying mechanisms explaining the increased
cardiovascular risk in formerly preeclamptic women. Cardiovascular disease is
in the Netherlands the number 1 cause of death in women. In men incidence of
cardiovascular morbidity is slowly declining, in contrast in women this number
unfortunately increases. This observation stresses the importance of early
recognition of women at risk. Early enough to let these women benifit from
proven effective preventative strategies. Pregnancy outcome can therefore help
in risk stratification
In the current study we want assess cardiovascular riskprofile in formerly
preeclamtic women and healthy controls (women without hypertensive
complications in previous pregnancy) (case-control). The 2 groups are
age-matched (all between 30-50 years old) and interval after first preganncy
(5-10 years).
Diastolic dysfunction is regarded as one of the first circulatory markers of
imminent cardiovascular disease and will therefore serve as primary outcome.
parameter.
Study objective
Main objective:
Have formerly preeclamptic women, 5 to 10 years post-partum, a higher
prevalence of a cardiovascular riskprofile compared to women with uncomplicated
pregancies in history.
Study design
Observational case-control study (both classic and novel cardiovascular risk
factors will be evaluated)
Study burden and risks
Study will be performed during a one-stop visit. (duration: 3 hours). Invasive
procedures limited to only one venapuncture (taking 25 ml blood), with a small
risk of developing a small hematoma. No administration of medication.
Participants are not obliged to certain interventions, however in case of
certain risk profile, participants will receive explicit advise concerning
future cardiovascular risk and possible lifestyle changes in order to reduce
certain risks. Counseling will be done according to national standard:
"cardiovascular risk management". Based on experience with ultrasound studies,
it is known that participants are unlikely to experience any burdens as a
consequence of the ultrasound measurements. The cuff surrounding the forearm
during the flow-mediated dilation (FMD) measurement to evaluate endothelial
function, can be experiences as unpleasant but (based on previous experience)
this measurement is usually well withstanded by participants. Other
measurements (questionaires, bloodpressure measurements, weighing and
measurement of intima media thickness are cosidered to have no risks or burdens
for participants.
Time investment is considerd minimal for participants. On the other hand,
participants can have important health benefit by recognitionf of certain
cardiovascular risks and can initiate well targeted preventative strategies
when risk is increased by enhancinig healthy lifestyle.
Daalseweg 197
6521 GH Nijmegen
NL
Daalseweg 197
6521 GH Nijmegen
NL
Listed location countries
Age
Inclusion criteria
Patients:
- women aged 30-50
- 5 to 10 year post partum
- preeclampsia in a previous pregnancy ;Controls:
- women aged 30-50
- 5 to 10 year post partum
- history of vascular uncomplicated pregnancies
Exclusion criteria
- women with diagnosed hypertension in advance of first pregnancy
- diabetes mellitus
- auto immune disease
- pregnancy
- women who do not want to be informed about results of cardiovascular screening
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL32728.091.10 |