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van CCT (UK)

van CCT (UK)

Antidepressants during pregnancy. Risk-benefit study for mother and child.

- candidate number1682
- NTR NumberNTR346
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR12-okt-2005
- Secondary IDsCCMO P03.0335, UMC U 03-024 
- Public TitleAntidepressants during pregnancy. Risk-benefit study for mother and child.
- Scientific TitleAntidepressants during pregnancy. Risk-benefit study for mother and child.
- ACRONYMOAZE (Dutch: Onderzoek Antidepressiva tijdens Zwangerschap, een Evaluatie)
- hypothesisThe use of modern antidepressants during pregnancy is associated with changes in fetal movement and development and can lead to seroius 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.
- Healt Condition(s) or Problem(s) studiedDepression, Pregnancy, Anxiety, Neonatal withdrawal syndrome, Developmental disorder
- Inclusion criteriaWomen 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 criteria1. Co medication with a similar or higher pregnancy risk factor;
2. Alcohol or drug addiction.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 12-jul-2003
- planned closingdate1-jun-2010
- Target number of participants400
- InterventionsThe 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).
- Primary outcomeThe 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 outcomeThe 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.
- TimepointsN/A
- Trial web site
- statusinclusion stopped: follow-up
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
Pfizer, Hersenstichting Nederland, Eli Lilly Nederland B.V., Arijan Porsius Fonds, Stichting doelmatig Geneesmiddelengebruik Midden Nederland
- PublicationsN/A
- Brief summaryThe use of modern antidepressants (SSRIs and non-SSRIs) is expandig, also in pregnant women. Although until now no increased risk for pregnancy loss or major structural malformations are documented, risk for neurobehavioal disorders or long term side effects are not jet established.
Antidepressant use during pregnancy can cause neonatal withdrawal effects. Discontinuation of antidepressants during pregancy on the other had can lead to re-emergence of the psychiatric disorder. Stress and anxiety are known for their harmful effects on the fetus. They may impair development and account for behaviour abnormalities of the child. To stop or continue treatment when a patient is pregnant is a great dilemma health care workers are facing. Moreover because they are lacking scientifical knowledge to make a profound risk-benefit decision. The OAZE-study is a prospective observational study among 400 women on the effects of continuation versus discontinuation of modern antidepressants during pregnancy.
By means of standardised questionaires the mental and physical sate of the mother and child are followed after the first trimester of pregnancy until 2 years after delivery. Using ultrasounc and blood samples additional data are collected on fetal behaviour, level of drug exposure and pharmacokinetics. With the rsults of the OAZE-study policies can be made regarding the use of antidepressants during pregnancy and regarding the required extra neonatal care after birth.
- Main changes (audit trail)
- RECORD12-okt-2005 - 14-sep-2009

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