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

Официальное название

QUVIVIQ® Pregnancy Registry

Обзор

This study will investigate pregnancy, neonatal, and infant outcomes in women exposed to QUVIVIQ during pregnancy compared to women unexposed to QUVIVIQ during pregnancy.

Вмешательства

• Препарат 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.
• Препарат 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.
• Другое No insomnia medication
  No insomnia medication was administered.

Первичные конечные точки

• Major congenital malformations classified according to MACDP [Срок оценки: Start of pregnancy up to 1 year of infant age]

Вторичные конечные точки (12)

• Pregnancy complications - number of participants with pre-eclampsia [Срок оценки: 20 weeks gestation until delivery/birth/labor]
• Pregnancy complications - number of participants with pregnancy-induced hypertension [Срок оценки: 20 weeks gestation until delivery/birth/labor]
• Pregnancy complications - number of participants with pre-term labor [Срок оценки: Start of pregnancy up to 37 weeks gestation]
• Pregnancy complications - number of participants with gestational diabetes [Срок оценки: Start of pregnancy until delivery/birth/labor]
• Pregnancy outcomes - number of participants with pregnancy outcome of elective or therapeutic pregnancy termination [Срок оценки: Start of pregnancy until delivery/birth/labor]
• Pregnancy outcomes - number of participants with pregnancy outcome of spontaneous abortion [Срок оценки: Start of pregnancy up to 20 weeks gestation]
• Pregnancy outcomes - number of participants with pregnancy outcome of fetal death or stillbirth [Срок оценки: 20 weeks gestation up to birth]
• Pregnancy outcomes - number of participants with pregnancy outcome of live birth [Срок оценки: 37 weeks gestation up to 40 weeks gestation]
• Pregnancy outcomes - number of participants with pregnancy outcome of pre-term birth [Срок оценки: 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 [Срок оценки: Start of pregnancy up to 1 year of infant age]
• Infant outcomes - infants categorized according to size for gestational age [Срок оценки: At birth of infant]
• Infant outcomes - number of infants with outcome of low birth weight [Срок оценки: At birth of infant]

Критерии участия

A) Eligibility criteria for prospective pregnancies:

Критерии включения

• 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.

Критерии исключения

• 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:

Критерии включения

• Diagnosis of insomnia disorder prior to pregnancy.
• Pregnancy has ended.
• Exposure to QUVIVIQ during pregnancy or within 5 half-lives prior to conception.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• IQVIA US Office — Durham

Канада · 1 центр

• Jodha Tishon — Toronto

Франция · 1 центр

• Hôpital Gui de Chauliac — Montpellier

Германия · 1 центр

• Charité - Universitätsmedizin Berlin — Berlin

Италия · 1 центр

• Azienda Ospedaliera Universitaria Policlinico Tor Vergata — Rome

Испания · 1 центр

• Hospital Txagorritxu — Vitoria-Gasteiz

Великобритания · 1 центр

• University College London Hospitals — London

Идентификаторы

NCT: NCT06498128 · ID-078A403 · 1000000033

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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