SMOK-study: selective serotonin reuptake inhibitor medication in pregnant women - effect on development of children

ISRCTN	ISRCTN53506435
DOI	https://doi.org/10.1186/ISRCTN53506435
Secondary identifying numbers	NTR740

Submission date: 22/11/2006
Registration date: 22/11/2006
Last edited: 28/06/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr C N van der Veere
Scientific

University Medical Centre Groningen (UMCG)
Beatrix Children's Hospital
P.O. Box 30001
Groningen
9700 RB
Netherlands

Email	c.n.van.der.veere@bkk.umcg.nl

Study information

Study design	Multicentre, prospective case-controlled parallel group trial
Primary study design	Observational
Secondary study design	Case-control study
Study setting(s)	Hospital
Study type	Screening
Scientific title
Study acronym	SMOK
Study objectives	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(s)	Received from the "Medisch Ethische Toetsings Commissie (METc) of the UMCG (Universitair Medisch Centrum Groningen)" on the 22nd January 2007.
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	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 study start date	15/04/2007
Completion date	30/11/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	120
Key inclusion criteria	Newborn child exposed to an SSRI in utero
Key exclusion criteria	1. Newborn child exposed to a non-SSRI antidepressant in utero 2. Newborn child exposed to anti-epileptic drugs in utero
Date of first enrolment	15/04/2007
Date of final enrolment	30/11/2014

Locations

Countries of recruitment

Netherlands

Study participating centre

University Medical Centre Groningen (UMCG)

Groningen
9700 RB
Netherlands

Sponsor information

University Medical Centre Groningen (UMCG) (The Netherlands)
Hospital/treatment centre

P.O. Box 30001
Groningen
9700 RB
Netherlands

Website	http://www.umcg.nl/azg/nl/english/azg/
"ROR"	https://ror.org/03cv38k47

Funders

Funder type

Hospital/treatment centre

University Medical Centre Groningen (UMCG) (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	28/05/2013		Yes	No