Condition category
Pregnancy and Childbirth
Date applied
22/11/2006
Date assigned
22/11/2006
Last edited
28/06/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.umcg.nl/azg/nl/english/azg/

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

Results - basic reporting

Publication summary

1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23785389

Publication citations

  1. 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.

Additional files

Editorial Notes