National postpartum psychosis prevention study

Women with a history of bipolar disorder or postpartum psychosis are at
extremely high risk (22 - 75%) of relapse peripartum (during pregnancy or
within 3 months postpartum). Some small studies demonstrated that prophylactic
pharmacotherapy peripartum is associated with a lower chance of relapse.
However, this needs to be balanced against the risk for potential negative
effects associated with the neonate.
Furthermore, there is a lack of studies on the development of infants born to
women with bipolar disorder.

The primary aim of this study is to investigate if prophylactic pharmacotherapy
peripartum is associated with a lower chance of relapse peripartum. In more
detail, we will investigate if there is a difference in relapse between
patients that used psychopharmaca during pregnancy and postpartum, and patients
that only used medication postpartum. We hypothesize that psychopharmaca use
during pregnancy and postpartum is associated with the lowest chance of
relapse.

The secondary aims of the study are:
1. Investigate what psychopharmaca in particular is associated with the lowest
chance of relapse. Antipsychotics (e.g. quetiapine, olanzapine or haloperidol)
and mood stabilizers (lithium, depakine, carbamazepine or lamotrigine) are most
commonly used (separate or a combination of a moodstabilizer and antipsychotic
medication) to reduce peripartum relapse. With respect to the present
literature, we hypothesize that a monotherapy with the mood stabilizer lithium
is associated with the lowest chance of relapse peripartum.
2. Investigate the timing, dosage and duration of pharmacotherapy in relation
to the chance of relapse peripartum. We hypothesize that more extensive use
(longer/higher dosage) of prophylactic pharmacotherapy is associated with a
lower chance of relapse.
3. Investigate obstetric complications and neonatal outcome in relation to
psychiatric illness and pharmacotherapy. We hypothesize that pharmacotherapy
peripartum is associated with a higher incidence of obstetric complications and
adverse neonatal outcome.
4. Investigate blood cells and serum biomarkers to predict peripartum relapse.
We hypothesize that auto-immune thyroid disease, and abnormalities of
angiogenic factors are more common in relapse patients compared to non-relapse
patients and women without a psychiatric history.
5. Investigate recovery (e.g. experience of mild mood complains and somatic
complains) twelve months after a pregnancy. We hypothesize that patients with a
history of bipolar disorder and/or a postpartum psychosis experience a more
slow recovery pattern after pregnancy.
6. To assess children*s neurodevelopment between 2 and 5 years of age. We
hypothesize that due to pharmacotherapy peripartum and the psychiatric illness
of the mother the development will be delayed compared to the controls.
7. To assess the mental and general health women with a history of bipolar
disorder or postpartum psychosis between 2 and 5 years postpartum.

A prospective naturalistic cohort study, enrolled pregnant women will be
treated as usual. Patients and controls will fill in a digital questionnaire at
32 weeks pregnancy and five time points postpartum (estimate time investment:
10 minutes each time). Furthermore, additional blood tubes will be taken off
once during regular blood assessment, which occurs between 26 and 30 weeks of
to investigate blood cells and serum biomarkers predictive for relapse.

No risks associated with participation. We estimate that participation will
take in total 4 hours.