Recruiting NCT06498128
Registry to Collect Information on Pregnancy, Neonatal, and Infant Outcomes in Pregnant Women Exposed to QUVIVIQ®
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Daridorexant, Non-orexin receptor antagonist medications for insomnia, No insomnia medication.
- Who it may be relevant to
- Registry conditions: Insomnia. Basic parameters: 15 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada, France, Germany, Italy +2
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
QUVIVIQ® Pregnancy Registry
Overview
This study will investigate pregnancy, neonatal, and infant outcomes in women exposed to QUVIVIQ during pregnancy compared to women unexposed to QUVIVIQ during pregnancy.
Interventions
- Drug 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. - Drug 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. - Other No insomnia medication
No insomnia medication was administered.
Primary outcome measures
- Major congenital malformations classified according to MACDP [Time frame: Start of pregnancy up to 1 year of infant age]
Secondary outcome measures (12)
- Pregnancy complications - number of participants with pre-eclampsia [Time frame: 20 weeks gestation until delivery/birth/labor]
- Pregnancy complications - number of participants with pregnancy-induced hypertension [Time frame: 20 weeks gestation until delivery/birth/labor]
- Pregnancy complications - number of participants with pre-term labor [Time frame: Start of pregnancy up to 37 weeks gestation]
- Pregnancy complications - number of participants with gestational diabetes [Time frame: Start of pregnancy until delivery/birth/labor]
- Pregnancy outcomes - number of participants with pregnancy outcome of elective or therapeutic pregnancy termination [Time frame: Start of pregnancy until delivery/birth/labor]
- Pregnancy outcomes - number of participants with pregnancy outcome of spontaneous abortion [Time frame: Start of pregnancy up to 20 weeks gestation]
- Pregnancy outcomes - number of participants with pregnancy outcome of fetal death or stillbirth [Time frame: 20 weeks gestation up to birth]
- Pregnancy outcomes - number of participants with pregnancy outcome of live birth [Time frame: 37 weeks gestation up to 40 weeks gestation]
- Pregnancy outcomes - number of participants with pregnancy outcome of pre-term birth [Time frame: Less than 34 weeks gestation up to 37 weeks gestation]
- Infant outcomes - number of infants with outcome of minor congenital malformations classified according to MACDP [Time frame: Start of pregnancy up to 1 year of infant age]
- Infant outcomes - infants categorized according to size for gestational age [Time frame: At birth of infant]
- Infant outcomes - number of infants with outcome of low birth weight [Time frame: At birth of infant]
Eligibility criteria
A) Eligibility criteria for prospective pregnancies:
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
- Exposure to any orexin receptor antagonist other than QUVIVIQ - including BELSOMRA® (suvorexant), DAYVIGO® (lemborexant), any orexin receptor antagonist newly approved during the study period, or any orexin receptor antagonist in pre-market clinical studies - during the current pregnancy or within 5 half-lives of the respective medication prior to conception.
B) Eligibility criteria for retrospective pregnancies:
Inclusion criteria
- Diagnosis of insomnia disorder prior to pregnancy.
- Pregnancy has ended.
- Exposure to QUVIVIQ during pregnancy or within 5 half-lives prior to conception.
Exclusion criteria
- Exposure to any orexin receptor antagonist other than QUVIVIQ - including suvorexant, lemborexant, any orexin receptor antagonist newly approved during the study period, or any orexin receptor antagonist in pre-market clinical studies - during pregnancy or within 5 half-lives of the respective medication prior to conception.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- IQVIA US Office — Durham
Canada · 1 center
- Jodha Tishon — Toronto
France · 1 center
- Hôpital Gui de Chauliac — Montpellier
Germany · 1 center
- Charité - Universitätsmedizin Berlin — Berlin
Italy · 1 center
- Azienda Ospedaliera Universitaria Policlinico Tor Vergata — Rome
Spain · 1 center
- Hospital Txagorritxu — Vitoria-Gasteiz
United Kingdom · 1 center
- University College London Hospitals — London
Identifiers
NCT: NCT06498128 · ID-078A403 · 1000000033