The objective of the study is to investigate the long-termeffects of lithium on the development of children who are exposed to lithium during pregnancy.
ID
Source
Brief title
Condition
- Neurological disorders congenital
- Foetal complications
- Manic and bipolar mood disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Differences in physical and psychological development between children who are
exposed to lithium in utero, and children who are not.
Secondary outcome
Not applicable
Background summary
Since 1950 lithium is used as a drug against bipolar disorder because of its
antimanic and antidepressive effect. Bipolar disorder is common in women in the
fertile phase, so a lot of research has been done about the influence of the
use of lithium on pregnancy and on the foetus. Especially congenital disorders
have been studied. Recent studies suggest that lithium would enlarge the risk
on congenital heart disorders and a large birth weight. Besides that there are
a lot of case reports that report other complications, like rythm disturbances
and thyroid dysfunction, but a significant difference could never be proved.
Animal studies suggest that lithium could influence the developing brain badly.
There has been almost no research after possible long-term effects of lithium.
The only publication, that did not show differences, was based on incomplete
data. Still lithium could have an effect on the motoric and/or psychologic
development of a child. This is why a more reliable study will be done after
the possible long-term effects of lithiumexposure during pregnancy.
Study objective
The objective of the study is to investigate the long-termeffects of lithium on
the development of children who are exposed to lithium during pregnancy.
Study design
Het onderzoek bestaat uit een vragenlijst voor de ouders en een bezoek van
ouder en kind aan het Leids Universitair Medisch Centrum. De enquĂȘte bevat
vragen over de sociale situatie van het kind, de lichamelijke en de
psychosociale ontwikkeling van het kind. Tijdens het bezoek aan het LUMC zal
het kind lichamelijk en psychologisch onderzocht worden.
Study burden and risks
The visit will take about 2 hours. The examination is not invasive and there
are no risks associated with participation.
Albinusdreef 2
2300 RC Leiden
Nederland
Albinusdreef 2
2300 RC Leiden
Nederland
Listed location countries
Age
Inclusion criteria
Lithiumexposure during pregnancy
Birth in the LUMC
Exclusion criteria
Not being exposes to lithium during pregnancy
Not being born in the LUMC
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 | NL20063.058.07 |