Many pregnant women are prescribed antidepressants. There is inconsistent scientific evidence about the benefits of antidepressants during pregnancy or about long-term risk to unborn children. In animals, unborn babies exposed to antidepressants can have problems with brain development. Several recent studies have found that children whose mothers took antidepressants during pregnancy were more likely to be diagnosed with neurodevelopmental problems such as autism. However, whether such problems are caused by the medication, or the mothers depression is still unclear. Better evidence on the benefits and risks of antidepressants during pregnancy will help doctors and patients to make decisions about using these medicines. We will use CPRD data to carry out a detailed study of this topic. We will use several new methods to analyse the data, which will help us to disentangle the role of antidepressants from the underlying depression. Our research questions are: i) In women with depression, what are the benefits or harms of using antidepressants during pregnancy? ii) In women prescribed antidepressants before pregnancy, what are the benefits or harms associated with continuing these medicines during pregnancy? iii) Is antidepressant use during pregnancy associated with brain development problems in children?
Observational intergenerational cohort study using the Clinical Practice Research Datalink (CPRD) linked to the Hospital Episodes Statistics and ONS death records using regression methods, propensity score matching, instrumental variable analysis, negative controls, and exposure discordant sibling control design.
Setting: Representative sample of UK General practice patients
Target population: Pregnant women with depression or prescribed antidepressants up to 1 year
before or during pregnancy
Inclusion Criteria: Women in the CPRD pregnancy register, who were registered with the
same CPRD Practice for at least 1 year before pregnancy and throughout the pregnancy period, who have a history of depression or antidepressant prescriptions recorded up to 1 year before or during pregnancy. A sub-cohort will include the mother-child pairs identified using CPRDs mother-baby link for whom follow-up data is available until the child is at least 4 years old.
Health technologies being assessed: Benefits and risks of starting antidepressants vs no drug
treatment for depression during pregnancy; continuing antidepressants vs stopping antidepressants during pregnancy.
Outcomes: Maternal: number of GP consultations,consultations and referrals for mental health problems, self harm, inpatient admission. Child:diagnosis of autism spectrum disorder, attention deficit hyperactivity disorder, intellectual disability.
Dheeraj Rai - Chief Investigator - University of Bristol
Hein Heuvelman - Corresponding Applicant - University of Bristol
Alan Emond - Collaborator - University of Bristol
David Gunnell - Collaborator - University of Bristol
Jonathan Evans - Collaborator - University of Bristol
Neil Davies - Collaborator - University of Bristol
Rachel Liebling - Collaborator - University Hospitals Bristol NHS Trust
Richard Morris - Collaborator - University of Bristol
Rupert Payne - Collaborator - University of Bristol
Yoav Ben-Shlomo - Collaborator - University of Bristol
CPRD Mother-Baby Link;HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data;Patient Level Index of Multiple Deprivation;Pregnancy Register