Clinical trial NCT06498128: Registry to Collect Information on Pregnancy, Neonatal, and Infant Outcomes in Pregnant Women Exposed to QUVIVIQ®
Official title: QUVIVIQ® Pregnancy Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Insomnia
Keywords: Pregnancy
Lead sponsor: Idorsia Pharmaceuticals Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Iqvia Pty Ltd
First posted: 2024-07-12
Enrollment: 785
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with insomnia disorder, monitored in a standard-of-care setting, and pregnant at time of enrollment (prospective pregnancies) will be assigned to a specific cohort according to the insomnia medication received. Women with insomnia disorder for whom the outcome of pregnancy is known prior to enrollment (retrospective pregnancies) will be analyzed in a separate case series.

Brief 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.


Eligibility criteria: A) Eligibility criteria for prospective pregnancies:

Inclusion Criteria:

1. Diagnosis of insomnia disorder prior to pregnancy.
2. Pregnancy is ongoing and outcome of pregnancy (i.e., pregnancy loss or live birth) is not known.
3. One of the following:

   1. Exposure to QUVIVIQ at any time during the current pregnancy or within 5 half-lives prior to conception.
   2. 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.
   3. 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:

1. Diagnosis of insomnia disorder prior to pregnancy.
2. Pregnancy has ended.
3. 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.

Primary outcomes:
measure: Major congenital malformations classified according to MACDP
timeFrame: Start of pregnancy up to 1 year of infant age
Secondary outcomes:
measure: Pregnancy complications - number of participants with pre-eclampsia
timeFrame: 20 weeks gestation until delivery/birth/labor
measure: Pregnancy complications - number of participants with pregnancy-induced hypertension
timeFrame: 20 weeks gestation until delivery/birth/labor
measure: Pregnancy complications - number of participants with pre-term labor
timeFrame: Start of pregnancy up to 37 weeks gestation
measure: Pregnancy complications - number of participants with gestational diabetes
timeFrame: Start of pregnancy until delivery/birth/labor
measure: Pregnancy outcomes - number of participants with pregnancy outcome of elective or therapeutic pregnancy termination
timeFrame: Start of pregnancy until delivery/birth/labor
measure: Pregnancy outcomes - number of participants with pregnancy outcome of spontaneous abortion
timeFrame: Start of pregnancy up to 20 weeks gestation
measure: Pregnancy outcomes - number of participants with pregnancy outcome of fetal death or stillbirth
timeFrame: 20 weeks gestation up to birth
measure: Pregnancy outcomes - number of participants with pregnancy outcome of live birth
timeFrame: 37 weeks gestation up to 40 weeks gestation
measure: Pregnancy outcomes - number of participants with pregnancy outcome of pre-term birth
timeFrame: Less than 34 weeks gestation up to 37 weeks gestation
measure: Infant outcomes - number of infants with outcome of minor congenital malformations classified according to MACDP
timeFrame: Start of pregnancy up to 1 year of infant age
measure: Infant outcomes - infants categorized according to size for gestational age
timeFrame: At birth of infant
measure: Infant outcomes - number of infants with outcome of low birth weight
timeFrame: At birth of infant
measure: Infant outcomes - number of infants with outcome of infant death
timeFrame: Birth of infant up to 1 year of infant age
measure: Infant outcomes - number of infants with outcome of hospitalization for serious illness
timeFrame: Birth of infant up to 1 year of infant age
measure: Infant outcomes - postnatal growth and development - weight-for-length
timeFrame: Birth of infant up to 1 year of infant age
measure: Infant outcomes - postnatal growth and development - head circumference-for-age
timeFrame: Birth of infant up to 1 year of infant age
measure: Infant outcomes - postnatal growth and development - length-for-age
timeFrame: Birth of infant up to 1 year of infant age
measure: Infant outcomes - postnatal growth and development - weight-for-age
timeFrame: Birth of infant up to 1 year of infant age
Other outcomes:
Locations:
city: Durham
country: United States
facility: IQVIA US Office
state: North Carolina
city: Toronto
country: Canada
facility: Jodha Tishon
state: Ontario
city: Montpellier
country: France
facility: Hôpital Gui de Chauliac
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Rome
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata
city: Vitoria
country: Spain
facility: Hospital Txagorritxu
city: London
country: United Kingdom
facility: University College London Hospitals
Study officials:
affiliation: Idorsia Pharmaceuticals Ltd.
name: Clinical Trials Study Director
role: STUDY_DIRECTOR
References: