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.
Study Type
OBSERVATIONAL
Enrollment
3
Prevalence of congenital malformations at birth
Time frame: 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
Time frame: At birth
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
Time frame: At birth
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.
Time frame: Throughout pregnancy, an average of 9 months
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).
Time frame: Throughout pregnancy, an average of 9 months
Prevalence of live birth
The birth of a living fetus at ≥ 20 gestational weeks or, if gestational age is unknown, weighing ≥ 350g.
Time frame: At birth
Prevalence rate of premature delivery
A live birth occurring at \<37 gestational weeks.
Time frame: At birth
Prevalence of infants born small for gestational age (SGA) at birth
Birth weight \<10th percentile for sex and gestational age using standard growth charts for full and preterm live-born infants.
Time frame: At birth
Prevalence of neonatal death
Time frame: Within the first 28 days of life
Prevalence infant death
Time frame: Throughout the first year of life
Prevalence of postnatal growth deficiency
Weight, length, or head circumference in \<10th percentile for sex and age using standard growth charts
Time frame: Throughout the two years of life
Prevalence of infant developmental delay
Failure to achieve the developmental milestones for chronological age, as defined by the Centers for Disease Control and Prevention (CDC)
Time frame: Throughout the two years of life
Prevalence of infant healthcare requirements and interventions not considered standard
including but not limited to: * Infant hospitalization due to serious illness * Emergency department visits * Specialist or other healthcare professional consultations * Developmental assessments and interventions * Therapeutic services * Educational support and adaptations
Time frame: Throughout the two years of life
Incidence and nature of all adverse events in pregnant participants
Time frame: Throughout pregnancy, an average of 9 months
Changes from baseline in Alkaline phosphatase (ALP)
Time frame: From the time of first elafibranor exposure throughout pregnancy and postpartum, an average of 2 years and 9 months
Changes from baseline in Bilirubin
Time frame: From the time of first elafibranor exposure throughout pregnancy and postpartum, an average of 2 years and 9 months
Changes from baseline in Alanine aminotransferase (ALT)
Time frame: From the time of first elafibranor exposure throughout pregnancy and postpartum, an average of 2 years and 9 months
Changes from baseline in Aspartate aminotransferase (AST)
Time frame: From the time of first elafibranor exposure throughout pregnancy and postpartum, an average of 2 years and 9 months
Changes from baseline in Gamma-glutamyl transferase (GGT)
Time frame: From the time of first elafibranor exposure throughout pregnancy and postpartum, an average of 2 years and 9 months
Changes from baseline in Albumin
Time frame: From the time of first elafibranor exposure throughout pregnancy and postpartum, an average of 2 years and 9 months
Changes from baselinein Bile Acids
Time frame: From the time of first elafibranor exposure throughout pregnancy and postpartum, an average of 2 years and 9 months
Changes from baseline in Creatine phosphokinase (CPK)
Time frame: From the time of first elafibranor exposure throughout pregnancy and postpartum, an average of 2 years and 9 months
Changes from baseline in Lipid Profile
Lipid profile includes total cholesterol, low density lipoproteins (LDL-C), high density lipoprotein (HDL-C), very low density lipoprotein and triglycerides
Time frame: From the time of first elafibranor exposure throughout pregnancy and postpartum, an average of 2 years and 9 months
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