Antidepressants during pregnancy: risk-benefit study for mother and child
| ISRCTN | ISRCTN25383361 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25383361 |
| Secondary identifying numbers | CCMO P03.0335, UMC U 03-024; NTR346 |
- 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
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 |
|---|---|
| f.f.t.ververs@apoth.azu.nl |
Study information
| Study design | Multicentre, non-randomised, two armed, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Antidepressants |
| Primary outcome measure | 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. |
| Secondary outcome measures | 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 |
| Overall study start date | 12/07/2003 |
| Completion date | 23/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
3508 GA
Netherlands
Sponsor information
University Medical Centre Utrecht (UMCU) (Netherlands)
University/education
University/education
PO Box 85500
Utrecht
3508 GA
Netherlands
| Website | http://www.umcutrecht.nl/zorg/ |
|---|---|
"ROR" |
https://ror.org/04pp8hn57 |
Funders
Funder type
Industry
Eli Lilly Nederland BV (The Netherlands)
No information available
Pfizer Netherlands (The Netherlands)
No information available
The Netherlands Brain Foundation (Hersenstichting Nederland) (The Netherlands)
No information available
Stichting Doelmatig Geneesmiddelengebruik Midden Nederland (The Netherlands)
No information available
Arijan Porsius Fonds (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
