1. the primary objective of this study is to examen the incidence and prevalence of PTSDand depression in pre-eclampsia patients after delivery2. a secondary objective is to identify risk factors during pregnancy, durante partu and postpartum…
ID
Source
Brief title
Condition
- Other condition
- Psychiatric and behavioural symptoms NEC
- Lifestyle issues
Synonym
Health condition
PTSD, depressie, angst stoornissen en lichamelijke klachten als gevolg hiervan.
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
PTSD incidence and prevalence
depression incidence and prevalence
Secondary outcome
quality of life as experienced
functional disability
physical complaints
outcome/health of the child
anxiety
acute stress
Background summary
Early-onset pre-eclampsia is a serious complication of pregnancy before 34
weeks of gestational age. It is defined as hypertension (not existing before)
and proteinuria in the second half of the pregnancy. Late-onset pre-eclampsia
differs from early-onset pre-eclampsia by the onset, which is after 37 weeks of
gestational age. The perinatal and maternal mortality and morbidity rates are
considerably lower in late-onset pre-eclampsia. The pathophysiological changes
in patients with pre-eclampsia such as vascular dysfunction, activation of the
coagulation cascade and increased capillary permeability can be explained by a
generalized inflammatory response resulting in endothelial dysfunction.
Pre-eclampsia is a major cause of both perinatal and maternal morbidity and
mortality.
While somatic disorders will disappear in approximately 3 months after
delivery, the impact of psychological effects is much greater both for the
mother and the father. The great amount of stress of the (acute) delivery, the
disease itself and the worry about the premature born child can lead to
psychological disorders like PTSD, depression, anxiety disorders and chronic
physical complaints . Women with a history of pre-eclampsia have an increased
risk for developing psychological problems such as PTSD shortly and in the late
period after delivery.
Study objective
1. the primary objective of this study is to examen the incidence and
prevalence of PTSDand depression in pre-eclampsia patients after delivery
2. a secondary objective is to identify risk factors during pregnancy, durante
partu and postpartum predicting PTSD and depression in women who have a history
of pre-eclampsia
The objective of this study is to determine the incidence of PTSD and PPD in
preeclampsia patients in the first year postpartum, while taking into account
addition risk factors related to PTSD or PPD in order to develop a prognostic
model. This model is expected to be useful in clinical practice for the
prediction of the development of PTSD or PPD at an early stage enabling the
development of primary prevention.
Secondary objective
If these women with pre-eclampsia have an increased risk of developing
psychiatric disorders this justifies primary/secundary prevention of PTSD,
depression, anxiety disorders and physical complaints. Furthermore if these
women have an increased risk for psychological problems than early signs of
these problems could be evaluated early after delivery and treated if
necessary.
This could be organised in a long term follow-up of women with pre-eclampsia in
an multidisciplinairy outdoor patient department where patients are screened
for risk factors for psychological disorders and treated if necessary. This
could be performed in co-operation with several disciplines like internal
medicine, cardiology and psychology.
Study design
This proposed study is set up as an observational prospective cohort study and
will be carried out in the Wilhelmina Children Hospital as part of the
University Medical Centre in Utrecht. The duration of the study will be
approximately 3-4 years.
Study burden and risks
The burden for the women is minimal and is restricted to 5 moments of 1 hour
each for this study.
risk and burden is one step above "no risk ". so minimal exeding no risk is
what we counted for this study. it's a non invasive study, but asking questions
by interview and filling out questionnaires may exaggerate emotions and
feelings can worry the women.
If this is the case the researchers and the social workers always are standby.
Lundlaan 6
Utrecht 3508 AE
NL
Lundlaan 6
Utrecht 3508 AE
NL
Listed location countries
Age
Inclusion criteria
being 18 year's or older
be able to speak and understand well the Dutch language
diagnostic criterium preeclampsia or HELLP
Exclusion criteria
none
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 | NL31029.041.12 |