Study identification

EU PAS number

EUPAS50643

Study ID

50644

Official title and acronym

Birth defects after maternal exposure to GLP1 agonists in early pregnancy: a comparative ENTIS cohort study

DARWIN EU® study

No

Study countries

Australia
Germany
Israel
Italy
Switzerland
United Kingdom

Study description

The aim of this study is to assess the risks linked to Glucagon-like peptide 1 (GLP1) agonists’ exposure during pregnancy for which safety data is absent. There are indeed until today no published available human exposure data on GLP1 agonists during pregnancy. Only one case of exposure to liraglutide in the 1st trimester was published with favourable outcome of the newborn and 7 cases in a registry for exenatide, however without information on follow-up. To fill this gap of knowledge, an observational cohort study is planned among participating centres of the European Network of Teratogen Information Services (ENTIS). Prospectively ascertained patients that received a GLP1 agonist during the first trimester of pregnancy will be eligible for the study. For each case, patients will be selected for the reference groups including diabetic patients treated with metformin and obese patients without diabetes, identified within the same TIS prospective cohort and similar for year of TIS contact. The association between GLP-1 agonist exposure and the risk of major birth defects will be the primary objective and evaluated using multivariate logistic regression analysis to estimate odds ratios with 95% CI. The risks for pregnancy terminations will also 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.

Study status

Planned
Research institutions and networks

Institutions

Networks

Contact details

Ursula Winterfeld

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:

Study start date

Planned:

Date of final study report

Planned:
Sources of funding
Other

More details on funding

Swiss National Science Foundation
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable