Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(A10BJ) Glucagon-like peptide-1 (GLP-1) analogues
Population studied

Age groups

Adults (18 to < 46 years)

Special population of interest

Pregnant women

Estimated number of subjects

200
Study design details

Main study objective

The aim of the study is to assess the risks linked to GLP1 agonists’ exposure during pregnancy. The primary objective is to prospectively evaluate the risk of major birth defects and to evaluate risks of spontaneous pregnancy losses (abortions and stillbirths) and pregnancy terminations after first trimester exposure to one GLP1 agonist compared to two reference groups.

Outcomes

The primary outcome of interest include the risk of major birth defects and the risks of spontaneous pregnancy losses (abortions or stillbirths) and pregnancy terminations. Secondary outcomes include: minor birth defects, neonatal outcomes including gestational age at birth and birth weight (sex and gestational age adapted) and preterm births.

Data analysis plan

Dataset description: Baseline demographic data will be presented using numbers and proportions for each group of key characteristics. Inferential measure such as standard errors, confidence intervals or significance tests will be avoided, since even small differences in a confounder may have a strong effect on the outcome. Primary outcome: The association between GLP-1 agonist exposure and the risk of major birth defects will be evaluated using multivariate logistic regression analysis to estimate odds ratios (OR) with 95% CI. The risks for pregnancy terminations will be considered competing risks and their frequency will be presented as cumulative incidence functions. A Cox regression model will be used to estimate the adjusted hazard ratios of these pregnancy outcomes associated with GLP-1 agonist exposure during the first trimester.