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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: Netherlands Trial Register
Last refreshed on: 28 April 2013
Main ID:  NTR740
Date of registration: 18/10/2006
Primary sponsor: University Medical Center Groningen (UMCG)
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 - SMOK
Date of first enrolment: 15/4/2007
Target sample size: 120
Recruitment status: recruiting
URL:  http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=740
Study type:  intervention
Study design:  Randomised: No; Masking: Single; Control: Active; Group: Parallel; Type: -  
Countries of recruitment
The Netherlands
Contacts
Name: A.F.  Bos
Address:  University Medical Center Groningen (UMCG), Beatrix Children's Hospital, P.O. Box 30001 9700 RB Groningen The Netherlands
Telephone:
Email:
Affiliation: 
Name: C.N.  Veere, van der
Address:  University Medical Center Groningen (UMCG), Beatrix Children's Hospital, P.O. Box 30001 9700 RB Groningen The Netherlands
Telephone:
Email: c.n.van.der.veere@bkk.umcg.nl
Affiliation: 
Key inclusion & exclusion criteria
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.

Age minimum:
Age maximum:
Gender:
Health Condition(s) or Problem(s) studied
Pregnancy, Selective serotonin reuptake inhibitors (SSRIs)

Intervention(s)
SSRI
Primary Outcome(s)
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(s)
Secondary ID(s)
ISRCTN53506435
N/A
Source(s) of Monetary Support
University Medical Center Groningen (UMCG)
Secondary Sponsor(s)
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