Registry to Collect Information on Pregnancy, Neonatal, and Infant Outcomes in Pregnant Women Exposed to QUVIVIQ®
Recruiting
Observational Study
Insomnia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 15 – 50
- Sex
- Female
- Study type
- Observational
- Participants needed
- 785 (estimated)
- Sponsor
- Idorsia Pharmaceuticals Ltd. · Industry
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About This Trial
This study will investigate pregnancy, neonatal, and infant outcomes in women exposed to QUVIVIQ during pregnancy compared to women unexposed to QUVIVIQ during pregnancy.
Trial Locations
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Eligibility Criteria
A) Eligibility criteria for prospective pregnancies:
Inclusion Criteria:
1. Diagnosis of insomnia disorder prior to pregnancy.
2. Pregnancy is ongoing and outcome of pregnancy (i.e., pregnancy loss or live birth) is not known.
3. One of the following:
1. Exposure to QUVIVIQ at any time during …
Contacts