The study will include participants who were exposed to at least one dose of elafibranor either within the three weeks before conception or at any time during pregnancy (based on estimated last menstrual period \[LMP\]).
Information will be collected from participants, their healthcare providers, published studies, and safety databases. Reports of pregnancy linked to elafibranor from clinical trials, spontaneous reports, or literature will also be included, with steps taken to avoid duplicates.
The study begins once the first participant is enrolled and ends after the last mother and child data are collected. It is planned to run for about 10 years, with infant follow-up lasting up to 2 years, for a maximum total duration of 12 years and 9 months.
The program is strictly observational. All medical care, visit schedules, and treatment decisions remain with healthcare providers. Only routine medical record data will be collected, and no extra tests or procedures are required.
Participation is voluntary, and written informed consent will be obtained before enrollment.
Maternal exposure to at least one dose of elafibranor, either: Within three weeks prior to conception (based on the estimated date of LMP) or At any time during pregnancy (from the estimated date of conception through pregnancy outcome).
Participants who were previously enrolled in this program during a past pregnancy and who meet inclusion criteria #1 for the subsequent pregnancy are eligible to enroll again.
Informed consent or IRB/IEC-approved waiver of informed consent (not applicable if reported by Ipsen PV according to usual pharmacovigilance practices).
Participant with mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain.
The participants of this study will be of any age who are exposed to at least one dose of elafibranor at any time during pregnancy, or since 3 weeks prior to the conception (based on estimated last menstrual period \[LMP\])
Other
Prospective
Elafibranor
DrugThe medicinal product elafibranor is prescribed in the usual manner in accordance with the terms of the marketing authorization of the participants' country.
Prevalence of congenital malformations at birth
Prevalence of major congenital malformations at birth
An abnormality of body structure or function that is present at birth; is of prenatal origin (i.e. birth defect); has significant medical, social, or cosmetic consequences for the affected individual; and typically requires medical intervention
Prevalence of minor congenital malformations at birth
An anomaly or abnormality of body structure that is present at birth, is of prenatal origin (i.e. birth defect), poses no significant health problem in the neonatal period, and tends to have limited social or cosmetic consequences for the affected individual
Prevalence of molar/ectopic pregnancy
Molar pregnancy is defined as an abnormal pregnancy that happens when a sperm fertilizes an egg that does not contain any genetic material. Ectopic pregnancy is defined as a pregnancy that occurs outside of the uterine cavity, usually in one of the fallopian tubes.
Prevalence of fetal loss
A fetal loss that occurs for any reason at any time during pregnancy. This includes spontaneous abortion (SAB), stillbirth, elective or therapeutic abortion, fetal loss (type not specified).
