Hypoparathyroidism
Conditions
Brief summary
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.
Interventions
Palopegteriparatide prescribed as per normal clinical practice
Sponsors
Ascendis Pharma A/S
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Pregnancies in which only the male partner is exposed to at least one dose of YORVIPATH.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The number of fetuses as reported by HCP | 21 months | — |
| Pregnancy outcomes | 21 months | * 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 | 21 months | — |
| Descriptive statistics of adverse events (AEs), including serious adverse events (SAEs) | 21 months | — |
| Number of hospitalizations including reasons for hospitalization | 21 months | — |
| Descriptive statistics of growth and development milestones as described by the Centers for Disease Control and Prevention (CDC 2021) or other accepted standard assessment | 21 months | — |
| Number of signs of hypocalcemia or hypercalcemia | 21 months | — |
| Descriptive statistics of infant developmental deficiency (CDC 2021) | 21 months | — |
| Descriptive statistics of postnatal growth deficiency or failure to thrive (FTT) | 21 months | — |
| Descriptive statistics of neonatal and infant mortality | 21 months | — |
| Maternal complications of pregnancy | 21 months | Including but not limited to * Premature rupture of membranes (PROM) * Preterm PROM (PPROM) * Pre-eclampsia * Gestational hypertension * Eclampsia * Proteinuria * Gestational diabetes * Intrauterine growth restriction (IUGR) * Polyhydramnios * Preterm delivery * Measures of fetal growth deficiency (e.g., small for gestational age) |
| Other maternal events of interest | 21 months | Number of * AEs, including SAEs * Events specific to hypoparathyroidism (e.g., hypercalcemia, hypocalcemia). Serum calcium concentrations at each trimester (if available) and at birth |
Countries
United States
Contacts
CONTACTYorvipath Pregnancy Inquiries
STUDY_DIRECTORMedical Director, MD
Ascendis Pharma A/S
Outcome results
None listed