QUVIVIQ® Pregnancy Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 785
- 试验地点
- 7
- 主要终点
- Major congenital malformations classified according to MACDP
研究概览
简要总结
This study will investigate pregnancy, neonatal, and infant outcomes in women exposed to QUVIVIQ during pregnancy compared to women unexposed to QUVIVIQ during pregnancy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 15 Years 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
QUIVIQ (Cohort A)
Women with insomnia exposed to QUVIVIQ during pregnancy or within 5 half-lives prior to conception.
干预措施: Daridorexant (Drug)
Non-orexin receptor antagonist medications for insomnia (Cohort B1)
Women exposed to other, non-orexin receptor antagonist medications for insomnia during pregnancy or within 5 half-lives of the respective insomnia medication prior to conception.
干预措施: Non-orexin receptor antagonist medications for insomnia (Drug)
No insomnia medications (Cohort B2)
Women who had no exposure to any insomnia medication during pregnancy and within 5 half-lives of any insomnia medication taken prior to conception.
干预措施: No insomnia medication (Other)
结局指标
主要结局
Major congenital malformations classified according to MACDP
时间窗: Start of pregnancy up to 1 year of infant age
Congenital malformations will be classified according to the Metropolitan Atlanta Congenital Defects Program (MACDP) classification system. All potential major congenital malformations identified by the participant's or the infant's healthcare providers will be evaluated by a qualified, independent committee of at least 3 teratologists using all available medical records. Classification will be based upon the teratologists' adjudication, who will be blinded to participant exposure status.
次要结局
- Pregnancy complications - number of participants with pre-eclampsia(20 weeks gestation until delivery/birth/labor)
- Pregnancy complications - number of participants with pregnancy-induced hypertension(20 weeks gestation until delivery/birth/labor)
- Pregnancy complications - number of participants with pre-term labor(Start of pregnancy up to 37 weeks gestation)
- Pregnancy complications - number of participants with gestational diabetes(Start of pregnancy until delivery/birth/labor)
- Pregnancy outcomes - number of participants with pregnancy outcome of elective or therapeutic pregnancy termination(Start of pregnancy until delivery/birth/labor)
- Pregnancy outcomes - number of participants with pregnancy outcome of spontaneous abortion(Start of pregnancy up to 20 weeks gestation)
- Pregnancy outcomes - number of participants with pregnancy outcome of fetal death or stillbirth(20 weeks gestation up to birth)
- Pregnancy outcomes - number of participants with pregnancy outcome of live birth(37 weeks gestation up to 40 weeks gestation)
- Pregnancy outcomes - number of participants with pregnancy outcome of pre-term birth(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(Start of pregnancy up to 1 year of infant age)
- Infant outcomes - infants categorized according to size for gestational age(At birth of infant)
- Infant outcomes - number of infants with outcome of low birth weight(At birth of infant)
- Infant outcomes - number of infants with outcome of infant death(Birth of infant up to 1 year of infant age)
- Infant outcomes - number of infants with outcome of hospitalization for serious illness(Birth of infant up to 1 year of infant age)
- Infant outcomes - postnatal growth and development - weight-for-length(Birth of infant up to 1 year of infant age)
- Infant outcomes - postnatal growth and development - head circumference-for-age(Birth of infant up to 1 year of infant age)
- Infant outcomes - postnatal growth and development - length-for-age(Birth of infant up to 1 year of infant age)
- Infant outcomes - postnatal growth and development - weight-for-age(Birth of infant up to 1 year of infant age)