RecruitingOBSERVATIONAL

Registry to Collect Information on Pregnancy, Neonatal, and Infant Outcomes in Pregnant Women Exposed to QUVIVIQ®

This study, called a registry, is collecting important information about pregnancy, newborn babies, and infants. It's for women who have had trouble sleeping (insomnia) and were pregnant. We are specifically looking at women who took a medicine called QUVIVIQ during their pregnancy, or shortly before getting pregnant. We want to compare their experiences and their babies' health with women who took different insomnia medicines, or no medication at all, during pregnancy. The main goal is to understand if taking QUVIVIQ during pregnancy has any specific effects on the mother or the baby. This helps us gather real-world information to make sure medicines are as safe as possible for everyone.

At a glance

Status

Recruiting

Sponsor

Idorsia Pharmaceuticals Ltd.

Enrolment target

785

Start

21 Nov 2024

Estimated completion

01 Mar 2033

Insomnia

What is this study about?

This study is a bit like gathering stories to understand a bigger picture. If you're a woman who has experienced insomnia and has been pregnant, this study is collecting information about your pregnancy journey and the health of your baby.

The main purpose is to learn more about how a specific insomnia medicine called QUVIVIQ might affect pregnancy. We're looking at details like the health of the baby when they are born, and their development as an infant. We compare this information from women who used QUVIVIQ with women who used other types of insomnia medicines, or even women who didn't take any insomnia medicine during pregnancy.

By collecting this information from many women, we can build a better understanding of how different treatments for insomnia during pregnancy might relate to the health of mothers and their babies. This kind of study helps doctors and patients make informed decisions about managing insomnia during pregnancy in the future.

Key takeaways

This study is gathering information about QUVIVIQ and pregnancy.
It's for women who had insomnia before or during pregnancy.
It compares outcomes for mothers and babies who used different insomnia treatments.
It helps doctors understand how QUVIVIQ affects pregnancy.
Your participation contributes to important medical knowledge.
You won't be given new medication as part of the study.

Who may be eligible?

This study is looking for women who are between 15 and 50 years old and have experienced insomnia before or during pregnancy.

If you are currently pregnant, you might be able to join if you took QUVIVIQ, another type of insomnia medicine (but not other 'orexin receptor antagonist' medicines like BELSOMRA or DAYVIGO), or no insomnia medicine at all, either during this pregnancy or just before getting pregnant.

If your pregnancy has already ended, you might be able to join if you took QUVIVIQ during that pregnancy or just before. Again, you shouldn't have taken other 'orexin receptor antagonist' medicines during that time.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a woman between 15 and 50 years old?
Did you have insomnia before or during your pregnancy?
Did you take QUVIVIQ, another insomnia medicine (not BELSOMRA/DAYVIGO), or no insomnia medicine while pregnant or just before?
If your pregnancy is ongoing, is the outcome (e.g., live birth or pregnancy loss) still unknown to the researchers?
If your pregnancy has ended, did you take QUVIVIQ during or just before that pregnancy?

Answer every question to see your result.

What does participation involve?

If you decide to take part, this study will mostly involve collecting information about your pregnancy and your baby's health. You won't be given any new medication as part of the study. Instead, the researchers will ask you questions about your health, any medicines you took, and the details of your pregnancy and your baby's health after birth. This information might be gathered through questionnaires or by looking at your medical records. The study is collecting information, not giving treatments. The total time you'd be involved largely depends on when you join and what information needs to be collected, but it focuses on gathering existing health details.

Potential risks and benefits

The main benefit of taking part is helping to improve medical knowledge. By sharing your experience, you'll contribute to a better understanding of how insomnia medicines like QUVIVIQ affect pregnancy, which can help future mothers. There are very few direct risks, as you won't be taking any new medicines or undergoing new procedures for the study. Your information will be kept private. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time without giving a reason, and it won't affect your medical care.

Locations (7)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

IQVIA US Office
Verified postcode
Durham, United States· Recruiting
Jodha Tishon
Verified postcode
Toronto, Canada· Not yet recruiting
Hôpital Gui de Chauliac
Verified postcode
Montpellier, France· Not yet recruiting
Charité - Universitätsmedizin Berlin
Verified postcode
Berlin, Germany· Not yet recruiting
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Verified postcode
Rome, Italy· Not yet recruiting
Hospital Txagorritxu
Verified postcode
Vitoria-Gasteiz, Spain· Not yet recruiting
University College London Hospitals
Verified postcode
London, United Kingdom· Not yet recruiting

Common questions

What is QUVIVIQ?

QUVIVIQ is a medicine prescribed to help people with insomnia (trouble sleeping).

Will I have to stop my current medication if I join?

No, this study is observing or collecting information about your existing medication use; it won't ask you to change or stop any medicines.

How will my personal information be kept private?

All your personal and medical information will be kept confidential and handled according to strict privacy rules to protect your identity.

What does 'insomnia disorder' mean?

Insomnia disorder means you regularly have trouble falling or staying asleep, and this affects your daytime life.

Do I need to live near a hospital to join?

Not necessarily. This study primarily collects information, often through questionnaires or reviewing existing medical records, so you might not need to visit a specific study site frequently.

How to find out more

Clinical Trial Information USA

idorsiaclinicaltrials@idorsia.com +1 856 661 37 21 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.