Registry to Collect Information on Pregnancy, Neonatal, and Infant Outcomes in Pregnant Women Exposed to QUVIVIQ®
Condition(s) studied
Investigational drug(s) / intervention(s)
Daridorexant: Dosing and treatment duration of QUVIVIQ as part of this observational study is at the discretion of the healthcare provider in accordance with local clinical practice and local labeling.
Non-orexin receptor antagonist medications for insomnia: Dosing and treatment duration of non-orexin receptor antagonist medications for insomnia as part of this observational study is at the discretion of the healthcare provider in accordance with local clinical practice and local labeling.
No insomnia medication: No insomnia medication was administered.
Study summary
This study will investigate pregnancy, neonatal, and infant outcomes in women exposed to QUVIVIQ during pregnancy compared to women unexposed to QUVIVIQ during pregnancy.
Eligibility
Primary outcome measure(s)
- Major congenital malformations classified according to MACDP — Start of pregnancy up to 1 year of infant age
Congenital malformations will be classified according to the Metropolitan Atlanta Congenital Defects Program (MACDP) classification system. All potential major congenital malformations identified by the participant's or the infant's healthcare providers will be evaluated by a qualified, independent committee of at least 3 teratologists using all available medical records. Classification will be based upon the teratologists' adjudication, who will be blinded to participant exposure status.
Trial sites (7)
| Facility | City | Region | Status |
|---|---|---|---|
| IQVIA US Office | Durham | North Carolina | Recruiting |
| Jodha Tishon | Toronto | Ontario | Not Yet Recruiting |
| Hôpital Gui de Chauliac | Montpellier | France | Not Yet Recruiting |
| Charité - Universitätsmedizin Berlin | Berlin | Germany | Not Yet Recruiting |
| Azienda Ospedaliera Universitaria Policlinico Tor Vergata | Rome | Italy | Not Yet Recruiting |
| Hospital Txagorritxu | Vitoria-Gasteiz | Spain | Not Yet Recruiting |
| University College London Hospitals | London | United Kingdom | Not Yet Recruiting |
More Idorsia Pharmaceuticals Ltd. trials in Spain
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06498128 on ClinicalTrials.gov ↗ ← All trials in Spain