|- candidate number||4758|
|- NTR Number||NTR1596|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||17-dec-2008|
|- Secondary IDs||NL 25268.068.08 azM/UM|
|- Public Title||Geheugenfunctie en doorbloeding van de hersenen na recente pre-eclampsie. |
|- Scientific Title||Cognitive function in relation to cerebral blood flow regulation after preeclampsia. |
|- hypothesis||Persistent cognitive complaints of part of the women who experienced severe preeclampsia 0.5-1.5 year ago can be objectified by neuropsychological as well as cerebral hemodynamic tests. |
|- Healt Condition(s) or Problem(s) studied||Pre-eclampsia, Cognition|
|- Inclusion criteria||1. Women who have been diagnosed with severe (clinical admission indispensable) early (< 34 weeks) preeclampsia 0.5-1.5 years ago in their first pregnancy; |
2. Age > 18 years;
3. Informed consent of the patient before participation into the study.
|- Exclusion criteria||1. Neurological or cerebrovascular disorders in case history;|
2. Kidney function disorder;
3. Use of statines;
4. Psychiatric case history or state (As I and II issues);
5. Use of anti-depression medicine;
6. Abuse of alcohol and/or drugs;
7. Smoking or refrained from smoking less than 2 years;
|- mec approval received||no|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||15-jan-2009|
|- planned closingdate||15-okt-2010|
|- Target number of participants||30|
|- Interventions||No interventions tested, but correlation between parameters (cerebral blood flow regulation and cognition) in a single patient group (former preeclamptics).|
Cerebral blood flow is measured non-invasively using transcranial Doppler ultasonography.
Cognition is objectified by neuropsychological test scores.
|- Primary outcome||Correlation between degree of disturbance of the cerebrovascular control system and cognitive function in former preeclamptic patients.|
|- Secondary outcome||Correlation between presence of cognitive complaints and cognitive function (NPO-scores).
Correlation between presence of cognitive complaints and cerebrovascular control parameters.
|- Timepoints||Single measurements within time span of 0.5-1.5 years after experience of preeeclampsia.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| E. Martens|
|- CONTACT for SCIENTIFIC QUERIES|| E. Martens|
|- Sponsor/Initiator ||University Hospital Maastricht (AZM)|
(Source(s) of Monetary or Material Support)
|University Hospital Maastricht (AZM), Eindhoven University of Technology|
|- Publications||Martens EGHJ, Peeters LLH, Gommer ED, Mess WH, Lima Passos V, van de Vosse FN, Reulen JPH. The visually-evoked cerebral blood flow response in women with a recent history of preeclampsia and/or Eclampsia. Ultrasound in Med an Biol. 2009, 35(1): 1-7|
|- Brief summary||Although the regulation of cerebral blood flow is known to be altered during preeclampsia, little is known about the state of the control mechanisms after the experience of preeclampsia. Nevertheless, several studies report evidence for formerly preeclamptics having a higher risk to die from stroke and a shorter life expectancy. Furthermore, our previous study shows that neurovascular coupling is abnormal in a subgroup of formerly preeclamptics. The question raised now is whether abnormalities in local blood flow regulation of formerly preeclamptics are related to cognitive function and to the persistent cognitive complaints which are regularly reported. |
A few studies show that cognitive function is disturbed after severe preeclampsia, but discuss that it is not known whether this effect is permanent or temporal and whether it is caused by organic damage. Our working hypothesis is that test-objectified cognitive function of formerly preeclamptics with or without subjective cognitive complaints is correlated with dynamic cerebrovascular control parameters measured by non-invasive techniques for recording cerebral autoregulation and neurovascular coupling. The major objective is to investigate whether cognitive complaints of formerly preeclamptics are caused by organic damage (measured by brain function) which may be used to predict an increased risk for future cerebrovascular complications such as stroke.
|- Main changes (audit trail)|
|- RECORD||17-dec-2008 - 3-feb-2009|