A Global Pregnancy Registry to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to YORVIPATH® (Palopegteriparatide) During Pregnancy and Breastfeeding
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The number of fetuses as reported by HCP
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 15 Years 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Pregnancies in which only the male partner is exposed to at least one dose of YORVIPATH.
研究组 & 干预措施
Palopegteriparatide
Pregnant women exposed to palopegteriparatide during pregnancy
干预措施: Palopegteriparatide (Drug)
结局指标
主要结局
The number of fetuses as reported by HCP
时间窗: 21 months
Pregnancy outcomes
时间窗: 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
时间窗: 21 months
Descriptive statistics of adverse events (AEs), including serious adverse events (SAEs)
时间窗: 21 months
Number of hospitalizations including reasons for hospitalization
时间窗: 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
时间窗: 21 months
Number of signs of hypocalcemia or hypercalcemia
时间窗: 21 months
Descriptive statistics of infant developmental deficiency (CDC 2021)
时间窗: 21 months
Descriptive statistics of postnatal growth deficiency or failure to thrive (FTT)
时间窗: 21 months
Descriptive statistics of neonatal and infant mortality
时间窗: 21 months
Maternal complications of pregnancy
时间窗: 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
时间窗: 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
次要结局
未报告次要终点