To evaluate pregnancy and infant outcomes among females diagnosed with familial hypercholesterolaemia (FH), exposed to Repatha® during pregnancy. This includes follow-up of their infants to the age of 12 months
Women diagnosed with familial hypercholesterolaemia (FH), treated at centres in Europe, South Africa and Australia, with pregnancy confirmed during the study observation period and who provide informed consent to participate in the study. Exposed subjects are women who received Repatha® during pregnancy and/or breastfeeding; unexposed subjects are women who have not received Repatha® during pregnancy and/or breast-feeding. In infants, exposure may occur in utero and/or via breast milk, within 15 weeks following the date of Repatha® dosing in the mother
Study Type
OBSERVATIONAL
Enrollment
4
Any incident of congenital anomaly
Any incidence of congenital anomaly recorded on the study specific eCRF
Time frame: From birth up to 12 months of age
End product of pregnancy summarised within 3 main categories: Fetal death, termination of pregnancy and live birth
Live birth(s), still birth, spontaneous loss, elective termination, ectopic pregnancy, complication of pregnancy (pre-eclampsia, gestational diabetes)
Time frame: From pregnancy diagnosis through to birth
Status of infant at delivery
Collection of data on gender; gestational age; Apgar score and birth weight
Time frame: At delivery
Details of any hospitalisations of infant, documented from delivery to 12 months of age.
Collection of hospitalisation reason, admission and discharge dates.
Time frame: From delivery to 12 months of age
Mode of delivery of infant
Collection of delivery mode classified by caesarian section, normal vaginal delivery, operative vaginal delivery and vaginal breech delivery
Time frame: At delivery
Growth of infant at 6 months post delivery
Data on infant growth measured by weight in kilograms.
Time frame: Between birth and 6 months of age
Details of any chronic medication taken by infant from birth to 12 months of age
Details of any chronic medication prescribed to infant from birth to 12 months of age
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Research Site
Camperdown, New South Wales, Australia
Research Site
Clayton, Victoria, Australia
Research Site
Graz, Austria
Research Site
Aalst, Belgium
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Edegem, Belgium
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La Louvière, Belgium
Research Site
Leuven, Belgium
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Liège, Belgium
Research Site
Hradec Králové, Czechia
Research Site
Liberec, Czechia
...and 38 more locations
Time frame: From birth to 12 months of age
Developmental milestones measured at 6 and 12 months of age
A check of developmental milestones made at 6 and 12 months of age. Details collected where expected milestones were not met.
Time frame: At 6 and 12 months of age of infant
Details of any complication of delivery
Recording the occurence of any complications of delivery as listed; requirement for blood transfusion, thromboembolism, fetal distress and amniotic fluid abnormality
Time frame: At delivery
Growth of infant at 12 months post delivery
Data on infant growth measured by weight in kilograms.
Time frame: Between birth and 12 months of age