Primary objective: To investigate whether sleep disturbances during pregnancy and/or in the perinatal period will predict postpartum psychopathology in women with an established diagnosis of bipolar disorder and/or a history of postpartum psychosis.…
ID
Source
Brief title
Condition
- Pregnancy, labour, delivery and postpartum conditions
- Manic and bipolar mood disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
(1) the occurrence of psychiatric symptoms during the first four weeks
postpartum
(2) the number and type of any intervention started for impending psychiatric
symptoms during the first four weeks postpartum.
Secondary outcome
nvt
Background summary
Treatment of women with bipolar disorder during pregnancy and in the postpartum
period is a major challenge. Decisions must be made about whether or not to
take psychiatric medication while pregnant and after delivery, weighing the
risks for the mother and the (unborn) child. Especially the postpartum period
is associated with an increased risk for the onset or exacerbation of bipolar
disorder (Kendell et al, 1987; Leibenluft 1996, Jones et al 2002) and maternal
death (Jones et al 2005). In a study of Viguera et al (2011) 52 % of women with
bipolar disorder developed a mood episode in the postpartum period (479
pregnancies/283 women). Subsyndromal symptoms were not investigated. Death,
caused by a psychiatric illness (severe self-neglect or suicide), is highest
for women in the year following delivery (Oates 2003, Lewis et al, 2007). In
the first two weeks postpartum the risk of having an episode is highest: 25-30%
with medication, and 70% without medication (Sitsen et al, 2011, Yonkers et al,
2011). Literature about subsyndromal symptoms in the postpartum is very scarce.
There is a much evidence for a relationship between sleep disruption and mood
disorders. A recent review suggests that sleep disturbances frequently precede
the onset of a bipolar mood episode by years and could be a long-term
riskfactor for any kind of mood disorder (Ritter et al, 2011).
Sleep reduction has been postulated as the final common pathway in the onset of
mania (Wehr et al, 1987) and frequently a temporal relation between sleep
disruption and a mood change is seen (Bauer et al, 2006). Ross et al (2005)
reviewed the association between sleep and perinatal mood disorders. This
extensive review indicated that the interaction between sleep and perinatal
mood disorders is significant. Preventing or decreasing sleep disturbance could
be a cost-effective method for prevention and treatment of postpartum mood
disorders. The authors stated that studies measuring both sleep and mood during
the perinatal period will provide important information about causes,
prevention and treatment of perinatal mood disorders. Only few studies assessed
sleep disturbances in detail. In a prospective study (Bilzsta et al 2010), no
difference in sleep-wake rhythm was found between women with bipolar disorder
and healthy women. However, that study was limited by the very small sample
size (23 patients versus 15 controls).
Women with postpartum psychosis may have a longer duration of labour and may be
more likely to deliver at night than controls (Sharma et al 2004, 2003a). Sleep
loss has been suggested as a final common pathway in the development of
psychosis in vulnerable women (Sharma 2003b). In the various guidelines (APA
2002; CANMAT, update 2009, Yatham; NVvP, 2008; NICE 2006) there is no
information about possible importance of delivery during daytime. To our
knowledge there is no study addressing forced deliveries during daytime in
relationship to postpartum psychopathology in bipolar disorder.
A better understanding of the impact of sleep disturbances during pregnancy and
in the perinatal period on postpartum psychopathology could help the
development of additional guidelines for prevention (and treatment) of
postpartum psychosis in women at risk.
The aim of this prospective study is to investigate the role of altered sleep
patterns during pregnancy and the perinatal period in women with bipolar
disorder and/or a history of postpartum psychosis, whether such
sleep-disturbances serve as a potential indicator and warning sign for
psychopathology later in pregnancy and during the perinatal and postpartum
periods, and whether early detection and management of sleep disturbances
improves the subsequent course of psychopathology up to the end of the
postpartum period.
In addition, the significance of mood symptoms (either syndromal or
subsyndromal) during pregnancy as predictors of postpartum psychopathology will
be investigated, as well as the influence of pharmacotherapy during pregnancy
and/or the postpartum period on postpartum psychopathology, and the
relationship between daytime delivery and postpartum psychopathology.
Study objective
Primary objective:
To investigate whether sleep disturbances during pregnancy and/or in the
perinatal period will predict postpartum psychopathology in women with an
established diagnosis of bipolar disorder and/or a history of postpartum
psychosis.
To investigate whether psychiatric symptoms, either syndromal or subsyndromal,
during pregnancy predict postpartum psychopathology.
Secondary objectives:
To investigate whether the use of psychotropic medication during pregnancy and
the perinatal period is associated with a decreased risk of postpartum
psychopathology
To investigate whether daytime labour/delivery is associated with a decreased
risk of postpartum psychopathology
To investigate whether the use of the Edinburgh Postnatal Depression Scale
predicts postpartum psychopathology in a population of pregnant women with
bipolar disorder.
To investigate whether sleep disturbances early in pregnancy predicts the
occurrence of subsyndromal mood symptoms or syndrome mood episodes later in
pregnancy.
Study design
This is a prospective, observational, naturalistic, non-interventional study.
Study burden and risks
Participants will have to make one extra visit at entry of the study. They will
have to complete a simple mood chart (Lifechart) via internet on a daily or
nearly-daily basis during the entire study (in some patients this may already
be part of routine monitoring during treatment).
In week 13 and week 26 of pregnancy and from week 38 of pregnancy to week 4
postpartum they have to complete a sleep-diary. At week 13 and week 26 of
pregnancy and from week 38 of pregnancy to week 4 postpartum and in week 12
postpartum they will have to complete various questionnaires. Participants will
have to wear an actimeter in week 13 and 26 of pregnancy and from week 38 of
pregnancy till week 4 postpartum.
Psychiatric and medical treatment will be given as usual. The study imposes no
additional risks to the participant and her child.
Hanzelaan 1
7607 NL Almelo
NL
Hanzelaan 1
7607 NL Almelo
NL
Listed location countries
Age
Inclusion criteria
bipolar disorder and/or postpartum psychosis in history
AND
pregnancy
Exclusion criteria
patients without informed consent
patients with current severe substance abuse
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 | NL37319.029.11 |