Effect of Antenatal SSRI Exposure on the QT interval of neonates (1)
Research type
Research Study
Full title
Is Antenatal Exposure to Selective Serotonin Reuptake Inhibitors (SSRIs) Associated with Prolongation of the QT Interval in Term Neonates (37 Complete Weeks Gestation or Greater)?
IRAS ID
148564
Contact name
Marie Lindsay-Sutherland
Contact email
Sponsor organisation
University of Southampton
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
Is Antenatal Exposure to Selective Serotonin Reuptake Inhibitors (SSRIs) Associated with Prolongation of the QT Interval in Term Neonates (37 Complete Weeks Gestation or Greater)?
SSRIs are a group of antidepressants that suppress the re-absorbtion of a chemical called Serotonin in the brain, and improve mood. SSRI use in the treatment of mental health problems has increased greatly since their introduction in the 1980's. When given in pregnancy they cause less fetal effects than other antidepressants. However they are still known to cause premature birth, heart defects and withdrawal symptoms in the baby. Withdrawal symptoms can occur in up to 30% of exposed babies, where as heart defects have been found to increase by 2-3 times against the normal rate of 1%. There is very limited information available for babies, but it is also thought it may cause lengthening of a certain portion of the heart beat, the QT interval, which has been shown to lead to sudden death in adults. The QT interval will be looked at in this study, comparing babies exposed to SSRIs in pregnancy with unexposed babies.
The study will be based in the UK, at the Maternity Unit of a District General Hospital, and will be carried out over 18-24 months.
A group of babies whose mothers took SSRIs whilst pregnant will have an Electrocardiogram (ECG) done when they are 2-3 days old. These will be compared with babies whose mothers did not, but whose babies were still in hospital because they were at risk of having an infection, but were found to be healthy.
The study hopes to see whether there is a link between SSRI use in pregnancy and lengthening of the QT interval and if so, extra surveillance may be considered for this group of babies.
This self funded study forms part of a Doctorate.
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
15/SW/0310
Date of REC Opinion
16 Dec 2015
REC opinion
Further Information Favourable Opinion