Database Study to Provide Information on Pregnancy and Infant Outcomes Among Women Exposed to QUV… (NCT06393504) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Database Study to Provide Information on Pregnancy and Infant Outcomes Among Women Exposed to QUVIVIQ (Daridorexant)
United States2,095 participantsStarted 2023-11-30
Plain-language summary
Healthcare claims database study to provide safety information on maternal, fetal and infant outcomes among women exposed to QUVIVIQ (daridorexant) during pregnancy
Who can participate
Age range15 Years – 50 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
1. Evidence of a singleton end of pregnancy event during the intake period.
2. ≥ 1 insomnia diagnosis during the period which begins 12 months prior to the date of conception and ends at the end of pregnancy.
3. Continuous medical and pharmacy insurance coverage during the period which begins 6 months prior to the date of conception and ends at the date of conception plus 40 weeks (equivalent to 42 gestational weeks).
4. Age 15 to 50 years at the date of conception.
5. No dispensing of known or suspected teratogenic medications during the period which begins 5 half lives of that medication prior to the date of conception and ends at the end of pregnancy.
6. No exposure to other orexin receptor antagonists during the exposure period, i.e., suvorexant, lemborexant, and any orexin receptor antagonists newly approved during the intake period.
What they're measuring
1
Prevalence of major congenital malformations (MCMs)