A Study to Assess the Pregnancy Outcome in Women Exposed... | NCT06744673

NCT06744673

Protocol Section

Identification Module

Results Section

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Annotation Section

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Document Section

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Derived Section

Miscellaneous Info Module

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
Cohort A: Dayvigo-exposed Cohort	Pregnant women participants with a diagnosis of insomnia within the 6 months before the estimated date of conception (DOC) and who have received at least 1 dose of Dayvigo at any time from 10 days after the last menstrual period (LMP) that is, 4 days prior to the DOC, which is 5 times the product's half-life, until the pregnancy outcome (that is, any trimester) will be observed retrospectively.	Other: No Intervention
Cohort B: Comparator-exposed Cohort	Pregnant women participants with a diagnosis of insomnia within the 6 months before the estimated DOC and who have received at least 1 dose of drug indicated for the treatment of insomnia other than Dayvigo from 5 times the product's half-life prior to the estimated DOC until the pregnancy outcome, and no exposure to Dayvigo between 10 days after the LMP and the pregnancy outcome (that is, any trimester) will be observed retrospectively.	Other: No Intervention
Cohort C: Untreated Unexposed Comparator Cohort	Pregnant women participants with a diagnosis of insomnia within the 6 months before the estimated DOC and who were not exposed to any prescribed 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) will be observed retrospectively.	Other: No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No Intervention	Other	This is a non-interventional study.	Cohort A: Dayvigo-exposed Cohort Cohort B: Comparator-exposed Cohort Cohort C: Untreated Unexposed Comparator Cohort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Live Births Reported With MCM in Women of Cohort A Subset and Cohort C	MCM will be defined as an abnormality of body structure or function that is present at birth, is of prenatal origin (that is, birth defect), has significant medical, social, or cosmetic consequences for the affected individual, and typically requires medical intervention. Congenital anomalies will be classified using the Centers for Disease Control and Prevention (CDC)'s Metropolitan Atlanta Congenital Defects Program (MACDP) system. Live birth will be defined as birth of a living fetus at greater than or equal to (>=) 20 gestational weeks or, if gestational age is unknown, a fetus weighing >=350 grams (g). Cohort A subset is defined as women with insomnia who are exposed to Dayvigo during the 1st trimester of pregnancy.	At estimated date of delivery (EDD)/pregnancy outcome (up to 1 year 10 months)
Percentage of Live Births Reported With MCM in Women of Cohort A and Cohort B Subsets	MCM will be defined as an abnormality of body structure or function that is present at birth, is of prenatal origin (that is, birth defect), has significant medical, social, or cosmetic consequences for the affected individual, and typically requires medical intervention. Cohort A subset is defined as women with insomnia who are exposed to Dayvigo during the 1st trimester of pregnancy and Cohort B subset is defined as women with insomnia who are exposed to a prescription insomnia drug other than Dayvigo during the 1st trimester of pregnancy.	At EDD/pregnancy outcome (up to 1 year 10 months)

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Live Births and Fetal Losses With MCM in Women of Cohort A and Cohort B Subsets	MCM will be defined as an abnormality of body structure or function that is present at birth, is of prenatal origin (that is, birth defect), has significant medical, social, or cosmetic consequences for the affected individual, and typically requires medical intervention. Congenital anomalies will be classified using the CDC's MACDP system. Live birth will be defined as birth of a living fetus at >=20 gestational weeks or, if gestational age is unknown, a fetus weighing >=350 g. Cohort A subset is defined as women with insomnia who are exposed to Dayvigo during the 1st trimester of pregnancy and Cohort B subset is defined as women with insomnia who are exposed to a prescription insomnia drug other than Dayvigo during the 1st trimester of pregnancy.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Must be female.
Must be 16 to 49 years of age
Has a clinically recognized pregnancy that overlaps with the data collection period between 01 Jun 2020 and the end of the data collection period
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:

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
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:

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)
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:

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
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:

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
Pregnancies not associated with a known pregnancy outcome.

ID	Term
D020919	Sleep Disorders, Intrinsic
D020920	Dyssomnias
D012893	Sleep Wake Disorders
D009422	Nervous System Diseases