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SMOK-study: SSRI Medication in pregnant women: Effect on development of children.


- candidate number2282
- NTR NumberNTR740
- ISRCTNISRCTN53506435
- Date ISRCTN created22-nov-2006
- date ISRCTN requested8-nov-2006
- Date Registered NTR18-okt-2006
- Secondary IDsN/A 
- Public TitleSMOK-study: SSRI Medication in pregnant women: Effect on development of children.
- Scientific TitleSMOK-study: SSRI Medication in pregnant women: Effect on development of children
- ACRONYMSMOK
- hypothesisRegarding 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) studiedPregnancy, Selective serotonin reuptake inhibitors (SSRIs)
- Inclusion criteriaNewborn child exposed to an SSRI in utero.
- Exclusion criteriaNewborn child exposed to a non-SSRI antidepressant in utero. Newborn child exposed to anti-epileptic drugs in utero.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 15-apr-2007
- planned closingdate15-apr-2015
- Target number of participants120
- InterventionsSSRI
- Primary outcomeIn 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 outcomeN/A
- Timepoints
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. C.N. Veere, van der
- CONTACT for SCIENTIFIC QUERIESProf. Dr. A.F. Bos
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- PublicationsPlanned: 4 manuscripts. One manuscript each on: otcome after 1 week; after 3 months; after 2 years; after 6 years.
- Brief summaryInfants 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)
- RECORD10-okt-2006 - 5-jun-2007


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