Study to Evaluate the Safety of Repatha® in Pregnancy

Study Overview
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Brief Summary
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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
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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

Official Title
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A Multinational Observational Study to Evaluate the Safety of Repatha® in Pregnancy

Conditions
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Hypercholesterolaemia, Pregnancy

Participation Criteria
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Eligibility Criteria
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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 exclusion criteria
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Repatha® exposed<br>Females with familial hypercholesterolaemia (FH) exposed to Repatha® in the 15 weeks prior to or during pregnancy or during breastfeeding | |
| Non exposed to Repatha®<br>Pregnant females with familial hypercholesterolaemia (FH) not exposed to Repatha® and enrolled into this study, overall and stratified by lipid lowering therapy use | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Any incident of congenital anomaly | Any incidence of congenital anomaly recorded on the study specific eCRF | From birth up to 12 months of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | From pregnancy diagnosis through to birth | 
| Status of infant at delivery | Collection of data on gender; gestational age; Apgar score and birth weight | At delivery | 
| Details of any hospitalisations of infant, documented from delivery to 12 months of age. | Collection of hospitalisation reason, admission and discharge dates. | 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 | At delivery | 
| Growth of infant at 6 months post delivery | Data on infant growth measured by weight in kilograms. | 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 | 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. | 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 | At delivery | 
| Growth of infant at 12 months post delivery | Data on infant growth measured by weight in kilograms. | Between birth and 12 months of age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypercholesterolaemia, Lipid lowering therapies, Pregnancy