The primary objective of this pilot study is to assess the prevalence of visual field defects in formerly eclamptic women. The secondary objective is to compare the vision-related quality of life between formerly eclamptic and normotensive parous…
ID
Source
Brief title
Condition
- Vision disorders
- Congenital and peripartum neurological conditions
- Maternal complications of pregnancy
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the prevalence of visual field defects in formerly
eclamptic.
Secondary outcome
The secondary study parameter is the score on the vision-related quality of
life questionnaire of formerly eclamptic women and matched controls.
Background summary
Eclampsia is the occurrence of convulsions in a preeclamptic woman, which can
not be attributed to another cause. Prodromal symptoms include headache, visual
disturbances, nausea and altered mental state. Eclampsia is thought to be a
form 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. The reversibility of this syndrome has been questioned. In previous
studies eclamptic women, as well as a number of severely preeclamptic women,
showed persistent cerebral white matter lesions on MRI on both short and long
term follow-up. The location of these lesions as found in PRES and eclampsia is
mainly parieto-occipital. Therefore the most common visual abnormality during
the acute phase of PRES is transient cortical blindness but homonymous
hemianopsia, visual neglect, scotomata and blurred vision can also occur. In
general eclamptic patients regain their vision, however, incidental permanent
visual field abnormalities, in particular hemianopsia but also blindness, have
been described to persist years after the acute phase. It might be possible
that unconscious hemianopsia is present in a considerable number of the
formerly eclamptic patients. Therefore, this study proposal entails the
prevalence of visual field defects in formerly eclamptic women. Furthermore,
vision-related quality of life is compared between formerly eclamptic and
normotensive parous control subjects.
Study objective
The primary objective of this pilot study is to assess the prevalence of visual
field defects in formerly eclamptic women. The secondary objective is to
compare the vision-related quality of life between formerly eclamptic and
normotensive parous control subjects.
Study design
Pilot study
Study burden and risks
All participants will be asked to fill out a vision related quality of life
questionnaire. In addition, formerly eclamptic women are asked to undergo
visual field testing. In case of abnormal visual field testing, the test will
be repeated once. In case of repeated abnormal visual field testing the
participant will be referred for an ophthalmologic examination by an
ophthalmologist to rule out glaucoma. There are no risks associated with
participation. The burden mainly consists of the time it takes to undergo
visual field testing and/or to fill out the questionnaire. The main benefit for
formerly eclamptic women is the possible early detection of treatable
ophthalmologic conditions.
Postbus 30001
9700 RB Groningen
NL
Postbus 30001
9700 RB Groningen
NL
Listed location countries
Age
Inclusion criteria
One group of women over 18 years old, who were diagnosed with eclampsia between 1988 and 2008.
Eclampsia is defined according to the definition by the International Society for the Study of Hypertension in Pregnancy.
One group of healthy parous controls who have been matched for age and year of index pregnancy to the formerly eclamptic group.
Exclusion criteria
Glaucoma
Epilepsy or other neurologic disorders, including a known cerebrovascular accident, intracranial infections or a history of any neurosurgical procedure.
Pregnancy
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 | NL27489.042.09 |