B1412 - Psychotropic medication use during pregnancy Impact on obstetric neonatal and early childhood outcomes - 02/08/2012

B number: 
B1412
Principal applicant name: 
Dr Sam Cartwright-Hatton (University of Sussex, UK)
Co-applicants: 
Prof Andy Field (University of Sussex, UK), Dr Andrea Malizia (University of Bristol, UK)
Title of project: 
Psychotropic medication use during pregnancy: Impact on obstetric, neonatal and early childhood outcomes.
Proposal summary: 

Aims

There is a body of research examining the impacts of medication for depression and anxiety in pregnancy. This suggests that maternal use of SSRIs and Tricyclic Antidepressants may have a negative impact on obstetric outcomes and on child development, when these mothers are compared with those who are unexposed. However, other research, including from the ALSPAC cohort, suggests that maternal depression and anxiety also have negative outcomes for the neonate and young child. Therefore, it is unclear whether the negative outcomes from the medication studies have arisen as a result of the medication, or because of the underlying condition that the medication was intended to treat. For ethical reasons, it has not been possible to conduct a randomised trial, comparing treated and untreated depressed and anxious pregnant women, therefore, databases and naturalistic studies have been used to tease out these relationships.

We plan to carry out a case control study using the ALSPAC data set because:

1. to date, there are only four studies that have managed to compare pregnant women who are and are not receiving medication for their mental health condition. Each of these studies has been very small, and substantially underpowered to detect small group differences or rare events.

2. All of the studies have focused on maternal depression, whereas the literature suggests that maternal stress and anxiety is just as problematic for the developing fetus.

3. None of the existing studies have focussed on outcomes that extend beyond the immediate neonatal period.

The ALSPAC dataset is ideally placed to address these difficulties, given its exceptionally large sample size, its detailed data on both maternal anxiety and depression, and its follow up into childhood and beyond.

Questions / Hypotheses

Do pregnant women using medication for the treatment of anxiety / depression have poorer outcomes on obstetric, neonatal, and early childhood variables than matched depressed / anxious pregnant women who do not use medication, and than a healthy, unmedicated control group?:

Exposure Variables

* Maternal self-reported use of medication for anxiety or depression during pregnancy.

* Maternal anxiety and depression during pregnancy.

* Maternal exposure to other psychotropic medicines

Outcome Variables

Neonatal outcomes:

* Fetal loss

* Neonatal death

* Length of gestation

* Birth weight

* Birth length

* Head circumference

* APGAR score at 1 and 5 minutes

* Length of hospital stay for newborn

* Special Care Baby Unit admission

Early childhood outcomes:

* Mother's bonding with baby

* Child growth

* Colic

* Jitteriness

* Child development

* Child temperament

Confounding Variables

* Maternal socio-economic status

* Maternal ethnicity

* Maternal age

* Maternal use of other agents known to affect development (alcohol, tobacco, street drugs, other prescription and non-prescription drugs).

Date proposal received: 
Thursday, 2 August, 2012
Date proposal approved: 
Thursday, 2 August, 2012
Keywords: 
Drugs, Pregnancy
Primary keyword: