Contact information
Type
Scientific
Primary contact
Dr C N van der Veere
ORCID ID
Contact details
University Medical Centre Groningen (UMCG)
Beatrix Children's Hospital
P.O. Box 30001
Groningen
9700 RB
Netherlands
c.n.van.der.veere@bkk.umcg.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR740
Study information
Scientific title
Acronym
SMOK
Study hypothesis
Regarding the facts that in the foetus 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 selective serotonin reuptake inhibitor (SSRI) in pregnancy could lead to problems in the development of the foetus, both structurally as in the case of morphogenesis, and in motor and cognitive development.
Ethics approval
Received from the "Medisch Ethische Toetsings Commissie (METc) of the UMCG (Universitair Medisch Centrum Groningen)" on the 22nd January 2007.
Study design
Multicentre, prospective case-controlled parallel group trial
Primary study design
Observational
Secondary study design
Case-control study
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Condition
SSRI (selective serotonin reuptake inhibitor), pregnancy
Intervention
120 healthy newborn babies were examined, 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.
Added as of 29/05/2007:
This study officially started recruiting patients on the 15th April 2007. The initial anticipated start date of this trial was 30/11/2006.
Intervention type
Drug
Phase
Not Specified
Drug names
Selective serotonin reuptake inhibitor
Primary outcome measure
1. In the first week after birth and at three months post-term: quality of general movements
2. At the age of 2 years and 6 years: motor and cognitive development
Secondary outcome measures
No secondary outcome measures
Overall trial start date
15/04/2007
Overall trial end date
30/11/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Newborn child exposed to an SSRI in utero
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
120
Participant exclusion criteria
1. Newborn child exposed to a non-SSRI antidepressant in utero
2. Newborn child exposed to anti-epileptic drugs in utero
Recruitment start date
15/04/2007
Recruitment end date
30/11/2014
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Medical Centre Groningen (UMCG)
Groningen
9700 RB
Netherlands
Sponsor information
Organisation
University Medical Centre Groningen (UMCG) (The Netherlands)
Sponsor details
P.O. Box 30001
Groningen
9700 RB
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
University Medical Centre Groningen (UMCG) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23785389
Publication citations
-
Results
de Vries NK, van der Veere CN, Reijneveld SA, Bos AF, Early neurological outcome of young infants exposed to selective serotonin reuptake inhibitors during pregnancy: results from the observational SMOK study., PLoS ONE, 2013, 8, 5, e64654, doi: 10.1371/journal.pone.0064654.