Antidepressants during pregnancy: risk-benefit study for mother and child

ISRCTN	ISRCTN25383361
DOI	https://doi.org/10.1186/ISRCTN25383361
Protocol serial number	CCMO P03.0335, UMC U 03-024; NTR346
Sponsor	University Medical Centre Utrecht (UMCU) (Netherlands)
Funders	Eli Lilly Nederland BV (The Netherlands), Pfizer Netherlands (The Netherlands), The Netherlands Brain Foundation (Hersenstichting Nederland) (The Netherlands), Stichting Doelmatig Geneesmiddelengebruik Midden Nederland (The Netherlands), Arijan Porsius Fonds (The Netherlands)

Submission date: 20/12/2005
Registration date: 20/12/2005
Last edited: 05/01/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr F.F.T. (Tessa) Ververs
Scientific

University Medical Center Utrecht
Division of Perinatology and Gynaecology/Division of Laboratory and Pharmacy
Room D.00.218
P.O. Box 85500
Utrecht
3508 GA
Netherlands

Phone	+31 (0)30 250 7190
Email	f.f.t.ververs@apoth.azu.nl

Study information

Primary study design	Interventional
Study design	Multicentre, non-randomised, two armed, parallel group trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	OAZE (Dutch: Onderzoek Antidepressiva tijdens Zwangerschap, een Evaluatie)
Study objectives	The use of modern antidepressants during pregnancy is associated with changes in foetal movement and development and can lead to serious withdrawal syndromes after birth. Antidepressant use as well as discontinuation of medication during pregnancy will have an effect on the mental development of the child.
Ethics approval(s)	Received from the local medical ethics committee
Health condition(s) or problem(s) studied	Depression and pregnancy
Intervention	The study is a prospective observational study and therefore there are no interventions. Subjects enter the study as antidepressant user (group A) or as having stopped taking medication (group B).
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Antidepressants
Primary outcome measure(s)	The effects of antidepressants are evaluated through measurements of foetal movement and development, registration of withdrawal syndromes after birth and measurement of child behaviour and development until the age of 2 years. Of 200 women who are on antidepressants during pregnancy (group A) and 200 women who stopped medication in the first trimester (group B) the social-economical status, smoking/drinking habits, co-medication, mental status (Edinburgh Depression Scale and State Trait Anxiety Inventory), specific pregnancy anxiety and blood level of the antidepressant are registered at 17, 28 and 37 weeks of pregnancy. Ultrasound recording of the foetal movements is also planned around these three time points. after delivery pregnancy outcome and observations of the baby during the first 10 days after birth are registered using the Finnigan score on withdrawal symptoms. Foetal drug exposure and neonatal drug elimination kinetics are estimated using umbilical cord blood and a blood sample of the child several hours after birth. At 3 months, 8 months and 2 years after birth, behaviour and mental development are tested using the CBCL, child behaviour list and the IBQ infant behaviour questionnaire. The results of the two study groups A and B are compared. Dose-effect relations and level of exposure-effect relations are evaluated in relation to the severity of the withdrawal symptoms.
Key secondary outcome measure(s)	1. The positive effects of antidepressant use on the mental state of the mother during pregnancy and delivery versus the effects of discontinuation of pharmacotherapy 2. Pharmacokinetic changes of the different antidepressants in the three phases of pregnancy
Completion date	23/12/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	400
Key inclusion criteria	Women who are pregnant and use one of the modern antidepressants (selective serotonin re-uptake inhibitor [SSRI] and non-SSRI) are included at 16 weeks of pregnancy, group A. Women who stopped taking antidepressants in the first trimester or just before pregnancy are included in group B. Women must be willing and give informed consent and must be able to read in Dutch in order to fill in the questionnaires.
Key exclusion criteria	1. Co-medication with a similar or higher pregnancy risk factor 2. Alcohol or drug addiction
Date of first enrolment	12/07/2003
Date of final enrolment	23/12/2006

Locations

Countries of recruitment

Netherlands

Study participating centre

University Medical Center Utrecht

Utrecht
3508 GA
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	01/07/2009		Yes	No