The objective of this study is to examine the consequences of the use of an SSRI in pregnancy for motor and cognitive development of the child, in the short and long term.
ID
Source
Brief title
SSRI Medication in pregnant women: Effect on Development of Children.
Condition
- Movement disorders (incl parkinsonism)
- Neonatal and perinatal conditions
- Developmental disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
In the first week after birth and at 3 months post-term: Quality of general
movements.
At the age of 2 and 6 years: Motor and cognitive development.
Secondary outcome
Not applicable.
Background summary
Infants of depressed mothers are at increased risk for developing cognitive and
motor problems. A major depression often is treated with drugs, also in
pregnant women, although the risk of the drug for the fetus is unknown.
Approximately 2% of the Dutch pregnant women is using an SSRI (selective
serotonin reuptake inhibitor) as antidepressant drug.
SSRI*s cross the placenta easily. The consequences of the use of an SSRI by the
mother for the child remain to be determined. Short-term consequences are,
among other things, an increased incidence of birth defects, withdrawal
symptoms, convulsions, low Apgar score, low birth weight, prematurity, and
admission to a neonatal intensive care unit. Long-term effects are
insufficiently examined.
Neurotransmitters, especially the ontogenetic *old *ones like serotonin, are
detectable in the embryo before the neurons are differentiated. Serotonin is
present in the fertilized egg and is involved in the morphogenesis of brain,
heart, craniofacial epithelium and other structures. In MAO- knockout mice in
which an excessive amount of serotonin is present, normal development of the
somatosensor cortex is absent. Both a deficiency as well as an excessive amount
of serotonin changes the amount and development of neurons in the brain.
Hypothesis: Regarding the facts that serotonin is involved in synthesis of
serotonergic neurons (autoregulation) as well as in the development of target
tissues such as specific parts of the brain, the use of SSRI in pregnancy could
lead to problems in the development of the fetus, both structurally as in the
case of morphogenesis, and in motor and cognitive development.
Study objective
The objective of this study is to examine the consequences of the use of an
SSRI in pregnancy for motor and cognitive development of the child, in the
short and long term.
Study design
A prospective controlled design.
Study burden and risks
The tests at the age of 1 week and 3 months concern the observation of
spontaneous movements and carry no burden for the child.
The test at the age of 2 years can be judged as a play situation in which the
child is invited to show certain skills.
The tests at the age of 6 years are divers and can easily be performed by
children of this age.
This research can only be performed with children because it concerns the
development of children. These tests carry no risks for the child.
Postbus 30.001
9700 RB Groningen
NL
Postbus 30.001
9700 RB Groningen
NL
Listed location countries
Age
Inclusion criteria
Newborn baby exposed to a SSRI in utero.
Exclusion criteria
1. Exposure to an anti-epileptic drug in utero.
2. Simultaneous exposure to a non-SSRI antidepressant as well as a SSRI in utero.
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 |
---|---|
ISRCTN | ISRCTN53506435 |
CCMO | NL13159.042.06 |