Clinical trial NCT06744673: A Study to Assess the Pregnancy Outcome in Women Exposed to Dayvigo® During Pregnancy Compared to an Unexposed Control Population
Official title: A Retrospective, Observational Study Using a Healthcare Database to Assess the Pregnancy Outcome in Women Exposed to Dayvigo® During Pregnancy Compared to an Unexposed Control Population
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Sleep Initiation and Maintenance Disorders
Pregnancy
Keywords: Insomnia
Pregnancy
Dayvigo
Lemborexant
E2006
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2024-12-20
Enrollment: 861
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include pregnant women with insomnia.

Brief summary: The primary purpose of the study is to compare the occurrence of major congenital malformations (MCMs) among live births between women with insomnia who are exposed to Dayvigo during the 1st trimester of pregnancy and women with insomnia who are not exposed to any prescription insomnia drugs at any time during the pregnancy and to compare the occurrence of MCMs among live births between women with insomnia who are exposed to Dayvigo during the 1st trimester of pregnancy and women with insomnia who are exposed to a prescription insomnia drug other than Dayvigo during the 1st trimester of pregnancy.

Detailed description: As this is a Retrospective Database study, the Study Start Date for this study references the date at which data will become available

Eligibility criteria: Inclusion Criteria:

1. Must be female.
2. Must be 16 to 49 years of age
3. Has a clinically recognized pregnancy that overlaps with the data collection period between 01 Jun 2020 and the end of the data collection period
4. Has continuous medical and pharmacy benefit coverage for a minimum of 6 months (Baseline Period) before the estimated date of conception and through the date of pregnancy outcome.

Cohort A:

1. Exposed to at least 1 dose of Dayvigo at any time from 10 days after the LMP, that is, approximately 4 days prior to the estimated DOC, defined as 14 days after the LMP, based on the product's half-life, until the pregnancy outcome
2. Has a diagnosis of insomnia recorded in her electronic healthcare data within 6 months before the estimated DOC, insomnia defined as an International Classification of Disease (ICD) 10-CM code G47.0x Insomnia or ICD 10 CM code F51.0x Insomnia not due to a substance or known physiological condition or Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) code 780.52. Or if the first exposure to Dayvigo occurs after the DOC, then must have a diagnostic code for insomnia prior to or on the first exposure to this drug.

Cohort B:

1. Exposed to at least 1 dose of prescription medication for insomnia other than Dayvigo from 5 times the product's half-life prior to the estimated DOC until the pregnancy outcome (that is, any trimester)
2. Has a diagnosis of insomnia recorded in her electronic healthcare data within 6 months before the estimated DOC, insomnia defined as an ICD 10-CM code G47.0x Insomnia or ICD 10 CM code F51.0x Insomnia not due to a substance or known physiological condition or DSM-5 code 780.52. Or if the first exposure to the prescription insomnia medication occurs after the DOC, then must have a diagnostic code for insomnia prior to or on the first exposure to this drug

Cohort C:

1. Not exposed to any prescription medication for the treatment of insomnia during pregnancy that is, from 5 times the product's half-life prior to the estimated DOC until the pregnancy outcome (that is, any trimester). NB: May be exposed during pregnancy to other drugs (that is, not for insomnia), but only provided that these are not associated with potential or known teratogenicity
2. Has a diagnosis of insomnia recorded in her electronic healthcare data within 6 months before the estimated DOC, insomnia defined as an ICD 10-CM code G47.0x Insomnia or ICD 10 CM code F51.0x Insomnia not due to a substance or known physiological condition or DSM-5 code 780.52

Exclusion Criteria:

1. Identified pregnancies with exposure to known teratogens during pregnancy, that is, from 14 days after the LMP to pregnancy outcome (any trimester) or to dual orexin receptor antagonists other than lemborexant (this includes, but it is not limited to, exclusion of suvorexant and daridorexant) from 5 times the product's half-life prior to the estimated DOC until the pregnancy outcome (any trimester) will be excluded
2. Pregnancies not associated with a known pregnancy outcome.

Primary outcomes:
measure: Percentage of Live Births Reported With MCM in Women of Cohort A Subset and Cohort C
timeFrame: At estimated date of delivery (EDD)/pregnancy outcome (up to 1 year 10 months)
measure: Percentage of Live Births Reported With MCM in Women of Cohort A and Cohort B Subsets
timeFrame: At EDD/pregnancy outcome (up to 1 year 10 months)
Secondary outcomes:
measure: Percentage of Live Births and Fetal Losses With MCM in Women of Cohort A and Cohort B Subsets
timeFrame: At EDD/pregnancy outcome (up to 1 year 10 months)
measure: Percentage of Live Births and Fetal Losses With MCM in Women of Cohort A Subset and Cohort C
timeFrame: At EDD/pregnancy outcome (up to 1 year 10 months)
measure: Percentage of Participants With Spontaneous Abortion (SAB) in Cohort A and Cohort B Subsets
timeFrame: From enrollment up to pregnancy outcome (up to 1 year 10 months)
measure: Percentage of Participants With SAB in Cohort A Subset and Cohort C
timeFrame: From enrollment up to pregnancy outcome (up to 1 year 10 months)
measure: Percentage of Participants With Stillbirth in Cohort A and Cohort B Subsets
timeFrame: From 20 gestational weeks up to pregnancy outcome (up to 1 year 10 months)
measure: Percentage of Participants With Stillbirth in Cohort A Subset and Cohort C
timeFrame: From 20 gestational weeks up to EDD/ pregnancy outcome (up to 1 year 10 months)
measure: Percentage of Participants With Preterm Birth in Cohort A and Cohort B Subsets
timeFrame: From enrollment up to pregnancy outcome (up to 1 year 10 months)
measure: Percentage of Participants With Preterm Birth in Cohort A Subset and Cohort C
timeFrame: From enrollment up to pregnancy outcome (up to 1 year 10 months)
measure: Percentage of Participants With Induced Termination in Cohort A and Cohort B Subsets
timeFrame: From enrollment up to date of induced termination (up to 1 year 10 months)
measure: Percentage of Participants With Induced Termination in Cohort A Subset and Cohort C
timeFrame: From enrollment up to date of induced termination (up to 1 year 10 months)
measure: Percentage of Infants With Small for Gestational Age (SGA) in Cohort A and Cohort B Subsets
timeFrame: At EDD/pregnancy outcome (up to 1 year 10 months)
measure: Percentage of Infants With SGA in Cohort A Subset and Cohort C
timeFrame: At EDD/pregnancy outcome (up to 1 year 10 months)
measure: Percentage of Live Births and Fetal Losses With MCM in Women of Cohort A, B and C
timeFrame: At EDD/pregnancy outcome (up to 1 year 10 months)
measure: Percentage of Participants With SAB in Cohort A, B and C
timeFrame: From enrollment up to pregnancy outcome (up to 1 year 10 months)
measure: Percentage of Participants With Stillbirth in Cohort A, B and C
timeFrame: From 20 gestational weeks up to EDD/ pregnancy outcome (up to 1 year 10 months)
measure: Percentage of Participants With Preterm Birth in Cohort A, B and C
timeFrame: From enrollment up to pregnancy outcome (up to 1 year 10 months)
measure: Percentage of Participants With Induced Termination in Cohort A, B and C
timeFrame: From enrollment up to date of induced termination (up to 1 year 10 months)
measure: Percentage of Infants With SGA in Cohort A, B and C
timeFrame: At EDD/pregnancy outcome (up to 1 year 10 months)
measure: Number of MCM From Postmortem With Non-live Birth in Cohort A and Cohort B
timeFrame: From enrollment up to pregnancy outcome (up to 1 year 10 months)
Other outcomes:
Locations:
city: Nutley
country: United States
facility: Eisai Trial Site #1
state: New Jersey
Study officials:
References: