Registry to Collect Information on Pregnancy, Neonatal, and Infant Outcomes in Pregnant Women Exp… (NCT06498128) | Clinical Trial Compass
RecruitingNot Applicable
Registry to Collect Information on Pregnancy, Neonatal, and Infant Outcomes in Pregnant Women Exposed to QUVIVIQ®
United States, Canada, France785 participantsStarted 2024-11-21
Plain-language 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.
Who can participate
Age range
15 Years – 50 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Diagnosis of insomnia disorder prior to pregnancy.
. Pregnancy is ongoing and outcome of pregnancy (i.e., pregnancy loss or live birth) is not known.
. One of the following:
. Exposure to QUVIVIQ at any time during the current pregnancy or within 5 half-lives prior to conception.
. Exposure to other, non-orexin receptor antagonist medications for insomnia during pregnancy or within 5 half-lives of the respective insomnia medication prior to conception.
. No exposure to any insomnia medication during pregnancy and within 5 half-lives of any insomnia medication taken prior to conception.
Exclusion criteria
. Diagnosis of insomnia disorder prior to pregnancy.
. Pregnancy has ended.
. Exposure to QUVIVIQ during pregnancy or within 5 half-lives prior to conception.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Major congenital malformations classified according to MACDP
Timeframe: Start of pregnancy up to 1 year of infant age