Antidepressant use, pregnancy, depression, anxiety, neonatal withdrawal syndrome, developmental disorder.
Conditions
Interventions
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).
Sponsors
University Medical Center Utrecht, The Netherlands
Eligibility
Inclusion criteria
Inclusion criteria: Women who are pregnant and use one of the modern antidepressants (SSRI and non-SSRI) are included at 16 weeks of pregnancy, group A. Women who stopped taking atnidepressants 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.
Exclusion criteria
Exclusion criteria: 1. Co medication with a similar or higher pregnancy risk factor; 2. Alcohol or drug addiction.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The effects of antidepressants are evaluated through measurements of fetal movement and development, registration of withdrawal syndromes aftr birth and measurement of child behaviour and development till 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 staus (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 fetal 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 Finniganscore on withdrawal symptoms. Fetal 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| The positive effects of antidepressant use on the mental state of the mother during pregnancy and delivery versus the effects of discontinuation of pharmacotherapy. Pharmacokinetic changes of the different antidepressants in the three phases of pregnancy. | — |
Contacts
Public ContactF.F.T. (Tessa) Ververs
University Medical Center Utrecht (UMCU) Division of Perinatology and Gynaecology/ Division of Laboratory and Pharmacy Roomnumber D.00.218, P.O. Box 85500
Outcome results
None listed