SMOK-study: selective serotonin reuptake inhibitor medication in pregnant women - effect on development of children
| ISRCTN | ISRCTN53506435 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53506435 |
| Protocol serial number | NTR740 |
| Sponsor | University Medical Centre Groningen (UMCG) (The Netherlands) |
| Funder | University Medical Centre Groningen (UMCG) (The Netherlands) |
- 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
Scientific
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 |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Multicentre, prospective case-controlled parallel group trial |
| Secondary study design | Case-control study |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Selective serotonin reuptake inhibitor |
| Primary outcome measure(s) |
1. In the first week after birth and at three months post-term: quality of general movements |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 30/11/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 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
9700 RB
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
