About this trial
The purpose of this registry study is to collect both prospective and retrospective data in women exposed to palopegteriparatide during pregnancy to assess risk of pregnancy and maternal complications, and adverse effects on the developing fetus, neonate, and infant and to assess infant outcomes through at least the first year of life.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants aged 15 to 50 years
Participants with exposure to at least one dose of YORVIPATH at any time within 15 days prior to conception and/or during pregnancy. The timeframe of 15 days prior to conception is calculated based on 5 times the YORVIPATH half life of ~ 60 hours
Participants providing written informed consent, verbal consent, or eConsent (depending on country regulations) and a Medical Release of Information. For adolescents under the age of majority, verbal or written informed assent by the pregnant minor (where applicable) and verbal or written informed consent by the parent/legal guardian will be obtained.
Disqualifiers
Pregnancies in which only the male partner is exposed to at least one dose of YORVIPATH.
Trial population
Participants with exposure to at least one dose of YORVIPATH at any time within 15 days prior to conception or during pregnancy. Prospective and retrospective pregnancies may be reported.
Trial design
Cohort
Other
Treatments tested in this trial
Palopegteriparatide
DrugPalopegteriparatide prescribed as per normal clinical practice
Treatment groups
Trial outcomes
Primary outcomes
The number of fetuses as reported by HCP
Pregnancy outcomes
* Live birth (preterm delivery, full-term delivery) * Spontaneous abortion * Pregnancy termination * Fetal death/stillbirth * Molar or ectopic pregnancy
Number of congenital malformations identified in the developing fetus, neonate, or infant
Descriptive statistics of adverse events (AEs), including serious adverse events (SAEs)
Sponsors and contacts
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