Hypercholesterolaemia, Pregnancy
Conditions
Keywords
hypercholesterolaemia, Lipid lowering therapies, Pregnancy
Brief summary
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
Detailed description
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
Interventions
None listed
Sponsors
Amgen
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Females diagnosed with Familial hypercholesterolaemia (FH). * Confirmed pregnancy during the study observation period. * Pregnancies identified retrospectively but within the study period will be included * Multiple pregnancies, occurring in the same woman within the study period, will all be included (as separate pregnancies) * Provided informed consent to follow-up in this study, for subject and their infant(s) born during the study observation period
Exclusion criteria
There are no
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Any incident of congenital anomaly | From birth up to 12 months of age | Any incidence of congenital anomaly recorded on the study specific eCRF |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Status of infant at delivery | At delivery | Collection of data on gender; gestational age; Apgar score and birth weight |
| Details of any hospitalisations of infant, documented from delivery to 12 months of age. | From delivery to 12 months of age | Collection of hospitalisation reason, admission and discharge dates. |
| Mode of delivery of infant | At delivery | Collection of delivery mode classified by caesarian section, normal vaginal delivery, operative vaginal delivery and vaginal breech delivery |
| Growth of infant at 6 months post delivery | Between birth and 6 months of age | Data on infant growth measured by weight in kilograms. |
| End product of pregnancy summarised within 3 main categories: Fetal death, termination of pregnancy and live birth | From pregnancy diagnosis through to birth | Live birth(s), still birth, spontaneous loss, elective termination, ectopic pregnancy, complication of pregnancy (pre-eclampsia, gestational diabetes) |
| Developmental milestones measured at 6 and 12 months of age | At 6 and 12 months of age of infant | A check of developmental milestones made at 6 and 12 months of age. Details collected where expected milestones were not met. |
| Growth of infant at 12 months post delivery | Between birth and 12 months of age | Data on infant growth measured by weight in kilograms. |
| Details of any complication of delivery | At delivery | Recording the occurence of any complications of delivery as listed; requirement for blood transfusion, thromboembolism, fetal distress and amniotic fluid abnormality |
| Details of any chronic medication taken by infant from birth to 12 months of age | From birth to 12 months of age | Details of any chronic medication prescribed to infant from birth to 12 months of age |
Countries
Australia, Austria, Belgium, Czechia, Denmark, Greece, Italy, Netherlands, Norway, Slovakia, Spain, Sweden, Switzerland, United Kingdom
Outcome results
None listed