Study type

Study topic

Disease /health condition
Human medicinal product

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness

Data collection methods

Secondary data collection
Non-interventional study

Non-interventional study design

Other

Non-interventional study design, other

Case-malformed control study
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(N03AX09) lamotrigine

Medical condition to be studied

Cleft lip and palate
Cleft palate
Population studied

Short description of the study population

Pregnant women who had first trimester exposure to the new anti-epileptic drug (AED) lamotrigine.

Age groups

Preterm newborn infants (0 – 27 days)
Term newborn infants (0 – 27 days)
Infants and toddlers (28 days – 23 months)

Special population of interest

Pregnant women

Estimated number of subjects

10061059
Study design details

Main study objective

To investigate more precisely whether first trimester exposure to lamotrigine (LTG) monotherapy is specifically associated with an increased risk of orofacial clefts (OCs) relative to other malformations, in a follow-up study involving 5 yearly updates (2009, 2010, 2011, 2012, and 2013).

Outcomes

Odds of lamotrigine exposure among OC registrations (cases) was compared with the odds of lamotrigine exposure among malformed non-OC registrations (controls). Explore whether lamotrigine exposure may be associated with other malformations, and in particularly, assess independent evidence for the association with club foot signalled in the original study.

Data analysis plan

Crude odds ratios (ORs) were calculated as well as ORs adjusted for maternal age, and adjusted for registry
Documents
Study publications
Janneke Jentink, Maria A Loane, Helen Dolk, Ingeborg Barisic, Ester Garne, Joan…
Jentink J, Dolk H, Loane MA, Morris JK, Wellesley D, Garne E, de Jong-van den B…
Dolk H, Jentink J, Loane M, Morris J, de Jong–van den Berg LT. Does lamotrigine…
Dolk H, Wang H, Loane M, Morris J, Garne E, Addor MC, Arriola L, Bakker M,Baris…