|- candidate number||2282|
|- NTR Number||NTR740|
|- Date ISRCTN created||22-nov-2006|
|- date ISRCTN requested||8-nov-2006|
|- Date Registered NTR||18-okt-2006|
|- Secondary IDs||N/A |
|- Public Title||SMOK-study:
SSRI Medication in pregnant women: Effect on development of children.|
|- Scientific Title||SMOK-study:
SSRI Medication in pregnant women: Effect on development of children|
|- hypothesis||Regarding the facts that in the fetus serotonin is involved in the 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 (selective serotonin reuptake inhibitor) 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. |
|- Healt Condition(s) or Problem(s) studied||Pregnancy, Selective serotonin reuptake inhibitors (SSRIs)|
|- Inclusion criteria||Newborn child exposed to an SSRI in utero.|
|- Exclusion criteria||Newborn child exposed to a non-SSRI antidepressant in utero.
Newborn child exposed to anti-epileptic drugs in utero.|
|- mec approval received||yes|
|- multicenter trial||yes|
|- planned startdate ||15-apr-2007|
|- planned closingdate||15-apr-2015|
|- Target number of participants||120|
|- Primary outcome||In the first week after birth and at 3 months post-term: Quality of general movements.
At the age of 2 years and 6 years: Motor and cognitive development.|
|- Secondary outcome||N/A|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr. C.N. Veere, van der|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. A.F. Bos|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG)|
(Source(s) of Monetary or Material Support)
|University Medical Center Groningen (UMCG)|
|- Publications||Planned: 4 manuscripts.
One manuscript each on: otcome after 1 week; after 3 months; after 2 years; after 6 years.|
|- Brief summary||Infants of depressed mothers are at 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, withdrawal symptoms, convulsions, low Apgar score and prematurity. Long-term effects are insufficiently examined.
Serotonin in detectable in the embryo very early, before the neurons are differentiated. It is involved in the morphogenesis of brain, heart, craniofacial epithelium and other structures. Both a deficiency as well as an excessive amount of serotonin changes the amount and development of neurons in the brain in animal models.
Hypothesis: The use of SSRI in pregnancy could lead to developmental problems in the fetus.
Objective of the study: To examine the consequences of the use of SSRI in pregnancy for motor and cognitive development of the child, in the short and long term.
Study-design: Prospective case-controlled.
Study population: 120 healthy newborn babies, of whom 60 have been exposed to SSRI in pregnancy; 30 normal controls and 30 infants of depressed mothers who did not use medication during pregnancy.|
|- Main changes (audit trail)|
|- RECORD||10-okt-2006 - 5-jun-2007|