The primary objective of this study is to determine the prevalence of white matter lesions and subjective/objective neurocognitive functioning in women several years after pregnancy compared to nulliparous women The secondary objective is to…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
- Pregnancy, labour, delivery and postpartum conditions
- Cognitive and attention disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the prevalence of white matter lesions assessed by
MRI using a 3 Tesla MRI.
Secondary outcome
Secundary study parameters are:
Scores on the questionnaires: cognitive failures questionnaire (CFQ), hospital
anxiety and depression questionnaire (HADS), Utrechtse coping lijst (UCL).
Scores on neurocognitive tests:
- Nederlandse Leestest voor Volwassenen (NLV)
- Wechsler Adult Intelligence Scale (WAIS) III letter-number sequencing and
digit span, digit-symbol coding, symbol search
- Corsi Block-Tapping Task
- 15-Word Learning test
- Location Learning test
- Grooved Pegboard
- Groningen Intelligence Test (GIT) II figure exploration
- Delis-Kaplan Executive Function System (D-KEFS) Trail Making test, Tower test
- STROOP Color Word test
- Verbal Fluency test
- Figure Fluency test
- Amsterdam Short-Term Memory (ASTM) test
Background summary
The incidence of brain white matter lesions (WML) in the longterm in formerly
(pre-)eclamptic women and women who had a normotensive pregnancy has recently
been investigated by our group. Neuroimaging (MRI) of women who experienced
eclampsia on average 7 years prior revealed WML*s in 41 %, following
preeclampsia this was 37 %, whereas women who experienced normotensive
pregnancies demonstrated WML*s in 21 % of the cases. Therefore, the exact
clinical importance of the presence of WML in this relatively young cohort
(average age 40 years) is unclear. The question arises whether these lesions
are a result of Posterior Reversible Encephalopathy Syndrome (PRES), in which
an acute increase in blood pressure exceeds the upper limit of cerebral
autoregulation, leading to forced dilatation, blood-brain barrier disruption
and cerebral edema formation. Another possibility is that they represent a risk
marker for future cardio/cerebrovascular disease. White matter lesions (WML)
are a frequent finding on T2-weighted MRI of the brain in elderly individuals,
but their prevalence and severity in younger asymptomatic populations is less
well studied. These lesions are seen commonly in individuals in their 50s and
60s, especially those with risk factors for small vessel disease such as
hypertension and diabetes. There is evidence that the presence and
particularly, the severity of WML are important risk factors for the
development of cognitive impairment, vascular dementia, Alzheimer*s disease and
stroke. In their 40s a significant number of otherwise healthy individuals have
small lesions, although the reported prevalence range is large (6-50%).
Pregnant women frequently report forgetfulness during pregnancy, but also in
the postpartum period. How long into the postpartum period these problems
persist is not clear. To our knowledge, no studies have been performed in women
several years after pregnancy compared to women who have never been pregnant.
The examination of WMLs and their neurocognitive sequelae in younger
individuals is important for a variety of reasons. If the pathogenesis of these
lesions is to be understood and potentially modifiable factors identified, then
the study of individuals in the earliest stages of development of the lesions
would be valuable. Moreover, the functional consequences of these lesions in
mid-life are of interest as many noncognitive neuropsychiatric syndromes have
been related to the lesions.
Study objective
The primary objective of this study is to determine the prevalence of white
matter lesions and subjective/objective neurocognitive functioning in women
several years after pregnancy compared to nulliparous women
The secondary objective is to determine the effect of educational level,
employment, marital status, age, cerebrovascular risk factors and anxiety and
depression on outcomes of questionnaires, neurocognitive tests and white matter
lesions
Study design
The proposed project is a retrospective cohort study, which will be performed
at the Department of Obstetrics and Gynecology of the University Medical Center
Groningen. The duration of this study will be approximately one year.
Study burden and risks
There are no risks from participation in this study. The extent of the burden
mainly exists of the time needed to make the MRI scan, do the neurocognitive
testen and fill out the questionnaires.
Hanzeplein 1, postbus 30001
9700 RB Groningen
NL
Hanzeplein 1, postbus 30001
9700 RB Groningen
NL
Listed location countries
Age
Inclusion criteria
One group of women who were never pregnant will be included in this study. Women will be recruited by means of an invitation which will be spread in local newspapers and on the internet. Women can reply to this invitation. From the repliers, 62 women will be matched for age and level of education with a healthy parous woman from a previous study.
Exclusion criteria
- Any pregnancy of more than 12 weeks gestation or current pregnancy
- Epilepsy or other neurologic disorder
- Pregnancy
- General MRI contraindications or claustrophobia
- Known cerebrovascular disease
- History of alcohol or substance abuse requiring therapy
- Insufficient comprehension of Dutch language
- Fertility treatment or diagnostic procedures
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 | NL38044.042.11 |