[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07345494":3,"trial-entities:NCT07345494":97,"trial-summary:NCT07345494":100},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":16,"phases":21,"enrollment_info":22,"interventions":25,"primary_outcomes":31,"secondary_outcomes":60,"sex":61,"minimum_age":62,"maximum_age":63,"healthy_volunteers":14,"eligibility_criteria":64,"std_ages":72,"locations":75,"central_contacts":85,"overall_officials":91,"references":95,"see_also_links":96},"NCT07345494","ASND0043","A Global Pregnancy Registry to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to YORVIPATH® (Palopegteriparatide) During Pregnancy and Breastfeeding","RECRUITING","2036-01","2026-02","2026-03-02","2026-02-18","Ascendis Pharma A\u002FS","INDUSTRY",false,"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.",null,[18],"Hypoparathyroidism",[],"OBSERVATIONAL",[],{"count":23,"type":24},50,"ESTIMATED",[26],{"type":27,"name":28,"description":29,"armGroupLabels":30},"DRUG","Palopegteriparatide","Palopegteriparatide prescribed as per normal clinical practice",[28],[32,35,38,40,42,44,46,48,50,52,54,57],{"measure":33,"timeFrame":34},"The number of fetuses as reported by HCP","21 months",{"measure":36,"description":37,"timeFrame":34},"Pregnancy outcomes","* Live birth (preterm delivery, full-term delivery)\n* Spontaneous abortion\n* Pregnancy termination\n* Fetal death\u002Fstillbirth\n* Molar or ectopic pregnancy",{"measure":39,"timeFrame":34},"Number of congenital malformations identified in the developing fetus, neonate, or infant",{"measure":41,"timeFrame":34},"Descriptive statistics of adverse events (AEs), including serious adverse events (SAEs)",{"measure":43,"timeFrame":34},"Number of hospitalizations including reasons for hospitalization",{"measure":45,"timeFrame":34},"Descriptive statistics of growth and development milestones as described by the Centers for Disease Control and Prevention (CDC 2021) or other accepted standard assessment",{"measure":47,"timeFrame":34},"Number of signs of hypocalcemia or hypercalcemia",{"measure":49,"timeFrame":34},"Descriptive statistics of infant developmental deficiency (CDC 2021)",{"measure":51,"timeFrame":34},"Descriptive statistics of postnatal growth deficiency or failure to thrive (FTT)",{"measure":53,"timeFrame":34},"Descriptive statistics of neonatal and infant mortality",{"measure":55,"description":56,"timeFrame":34},"Maternal complications of pregnancy","Including but not limited to\n\n* Premature rupture of membranes (PROM)\n* Preterm PROM (PPROM)\n* Pre-eclampsia\n* Gestational hypertension\n* Eclampsia\n* Proteinuria\n* Gestational diabetes\n* Intrauterine growth restriction (IUGR)\n* Polyhydramnios\n* Preterm delivery\n* Measures of fetal growth deficiency (e.g., small for gestational age)",{"measure":58,"description":59,"timeFrame":34},"Other maternal events of interest","Number of\n\n* AEs, including SAEs\n* Events specific to hypoparathyroidism (e.g., hypercalcemia, hypocalcemia). Serum calcium concentrations at each trimester (if available) and at birth",[],"FEMALE","15 Years","50 Years",{"inclusion":65,"exclusion":69,"raw_text":71},[66,67,68],"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\u002For 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\u002Flegal guardian will be obtained.",[70],"Pregnancies in which only the male partner is exposed to at least one dose of YORVIPATH.","Inclusion Criteria:\n\n* Participants aged 15 to 50 years\n* Participants with exposure to at least one dose of YORVIPATH at any time within 15 days prior to conception and\u002For during pregnancy. The timeframe of 15 days prior to conception is calculated based on 5 times the YORVIPATH half life of \\~ 60 hours\n* 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\u002Flegal guardian will be obtained.\n\nExclusion Criteria:\n\n* Pregnancies in which only the male partner is exposed to at least one dose of YORVIPATH.",[73,74],"CHILD","ADULT",[76],{"facility":77,"status":7,"city":78,"state":79,"zip":80,"country":81,"geoPoint":82},"Ascendis Investigational Site","Morgantown","West Virginia","26508","United States",{"lat":83,"lon":84},39.62953,-79.9559,[86],{"name":87,"role":88,"phone":89,"email":90},"Yorvipath Pregnancy Inquiries","CONTACT","877-229-2184","yorvipathpregnancy@ubc.com",[92],{"name":93,"affiliation":12,"role":94},"Medical Director, MD","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":98,"biomarkers":99},[18],[],{"nct_id":4,"found":101,"summary":102,"prompt_version":112},true,{"design":103,"status":104,"heading":105,"summary":106,"follow_up":107,"word_count":108,"commitments":109,"compensation":110,"drugs_mentioned":111},"This is an observational study, meaning researchers will collect information without giving you a specific treatment. It plans to include 50 women.","completed","YORVIPATH® Pregnancy Registry for Hypoparathyroidism","This study is a registry to understand the effects of YORVIPATH® (Palopegteriparatide) when used by women with hypoparathyroidism (a condition where the body doesn't make enough parathyroid hormone) during pregnancy and breastfeeding. Researchers want to collect information on how YORVIPATH® affects the mother, the developing baby, and the infant after birth. They will look at pregnancy outcomes and any birth defects. You may be able to join if you are a woman between 15 and 50 years old and have been exposed to YORVIPATH® shortly before or during pregnancy. The study aims to enroll 50 participants. The success of this study will be measured by tracking the number of babies, pregnancy outcomes, and any birth defects identified up to 21 months.","Participants will be followed to assess pregnancy outcomes and congenital malformations up to 21 months.",121,"Not specified in the trial record.","Not stated in the trial record.",[28],"v2"]