Sleep Initiation and Maintenance DisordersNCT06744673
A Study to Assess the Pregnancy Outcome in Women Exposed to Dayvigo® During Pregnancy Compared to an Unexposed Control Population
An observational study of Sleep Initiation and Maintenance Disorders and Pregnancy, run by Eisai Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep Initiation and Maintenance Disorders, Pregnancy
- How many people
- 861 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2025to 30 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: The study population will include pregnant women with insomnia.
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- No Intervention
- Keywords
- Insomnia, Pregnancy, Dayvigo, Lemborexant, E2006
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
This is a non-interventional study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At EDD/pregnancy outcome (up to 1 year 10 months)
Secondary outcomes (19)
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.
Measured: At EDD/pregnancy outcome (up to 1 year 10 months)
Percentage of Live Births and Fetal Losses 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 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.
Measured: At EDD/pregnancy outcome (up to 1 year 10 months)
Percentage of Participants With Spontaneous Abortion (SAB) in Cohort A and Cohort B Subsets
SAB is defined as an involuntary fetal loss or the expulsion of the products of conception occurring at less than (<) 20 gestational weeks. 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.
Measured: From enrollment up to pregnancy outcome (up to 1 year 10 months)
Percentage of Participants With SAB in Cohort A Subset and Cohort C
SAB is defined as an involuntary fetal loss or the expulsion of the products of conception occurring at <20 gestational weeks. Cohort A subset is defined as women with insomnia who are exposed to Dayvigo during the 1st trimester of pregnancy.
Measured: From enrollment up to pregnancy outcome (up to 1 year 10 months)
Percentage of Participants With Stillbirth in Cohort A and Cohort B Subsets
Stillbirth is defined by the American College of Obstetricians and Gynecologists (ACOG), an involuntary fetal loss occurring 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.
Measured: From 20 gestational weeks up to pregnancy outcome (up to 1 year 10 months)
Percentage of Participants With Stillbirth in Cohort A Subset and Cohort C
Stillbirth is defined by the ACOG, an involuntary fetal loss occurring 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.
Measured: From 20 gestational weeks up to EDD/ pregnancy outcome (up to 1 year 10 months)
Percentage of Participants With Preterm Birth in Cohort A and Cohort B Subsets
Preterm birth is defined as a live birth occurring at <37 gestational weeks. 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.
Measured: From enrollment up to pregnancy outcome (up to 1 year 10 months)
Percentage of Participants With Preterm Birth in Cohort A Subset and Cohort C
Preterm birth is defined as a live birth occurring at <37 gestational weeks. Cohort A subset is defined as women with insomnia who are exposed to Dayvigo during the 1st trimester of pregnancy.
Measured: From enrollment up to pregnancy outcome (up to 1 year 10 months)
Percentage of Participants With Induced Termination in Cohort A and Cohort B Subsets
Induced termination is defined as a pregnancy terminated according to the participant's decision (elective termination), with or without medical or therapeutic indication (therapeutic indication occurs when the pregnancy endangers the mother's health or the fetus has a condition incompatible with normal life). 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.
Measured: From enrollment up to date of induced termination (up to 1 year 10 months)
Percentage of Participants With Induced Termination in Cohort A Subset and Cohort C
Induced termination is defined as a pregnancy terminated according to the participant's decision (elective termination), with or without medical or therapeutic indication (therapeutic indication occurs when the pregnancy endangers the mother's health or the fetus has a condition incompatible with normal life). Cohort A subset is defined as women with insomnia who are exposed to Dayvigo during the 1st trimester of pregnancy.
Measured: From enrollment up to date of induced termination (up to 1 year 10 months)
Percentage of Infants With Small for Gestational Age (SGA) in Cohort A and Cohort B Subsets
SGA will be evaluated as weight at birth in <10th percentile for sex and gestational age using standard growth charts for full and preterm live-born infants. 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.
Measured: At EDD/pregnancy outcome (up to 1 year 10 months)
Percentage of Infants With SGA in Cohort A Subset and Cohort C
SGA will be evaluated as weight at birth in <10th percentile for sex and gestational age using standard growth charts for full and preterm live-born infants. Cohort A subset is defined as women with insomnia who are exposed to Dayvigo during the 1st trimester of pregnancy.
Measured: At EDD/pregnancy outcome (up to 1 year 10 months)
Percentage of Live Births and Fetal Losses With MCM in Women of Cohort A, B and 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 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.
Measured: At EDD/pregnancy outcome (up to 1 year 10 months)
Percentage of Participants With SAB in Cohort A, B and C
SAB is defined as an involuntary fetal loss or the expulsion of the products of conception occurring at less than (<) 20 gestational weeks.
Measured: From enrollment up to pregnancy outcome (up to 1 year 10 months)
Percentage of Participants With Stillbirth in Cohort A, B and C
Stillbirth is defined by the ACOG, an involuntary fetal loss occurring at >=20 gestational weeks or, if gestational age is unknown, a fetus weighing >=350 g.
Measured: From 20 gestational weeks up to EDD/ pregnancy outcome (up to 1 year 10 months)
Percentage of Participants With Preterm Birth in Cohort A, B and C
Preterm birth is defined as a live birth occurring at <37 gestational weeks.
Measured: From enrollment up to pregnancy outcome (up to 1 year 10 months)
Percentage of Participants With Induced Termination in Cohort A, B and C
Induced termination is defined as a pregnancy terminated according to the participant's decision (elective termination), with or without medical or therapeutic indication (therapeutic indication occurs when the pregnancy endangers the mother's health or the fetus has a condition incompatible with normal life).
Measured: From enrollment up to date of induced termination (up to 1 year 10 months)
Percentage of Infants With SGA in Cohort A, B and C
SGA will be evaluated as weight at birth in <10th percentile for sex and gestational age using standard growth charts for full and preterm live-born infants.
Measured: At EDD/pregnancy outcome (up to 1 year 10 months)
Number of MCM From Postmortem With Non-live Birth in Cohort A and Cohort B
Any findings of MCMs from postmortem examination of pregnancies with non-live birth outcomes (that is, abortions, fetal deaths/stillbirths) will be reported separately.
Measured: From enrollment up to pregnancy outcome (up to 1 year 10 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start3 Jan 2025
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Initiation and Maintenance DisordersStudies of the same condition, open and under way.
- More trials run by Eisai Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 861 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06744673
- Sponsor's protocol ID
- E2006-A001-604
- Status last verified
- Jun 2025
- First submitted
- 17 Dec 2024
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06744673
- Acronym / sponsor ID
- E2006-A001-604
- Keywords
- Insomnia, Pregnancy, Dayvigo, Lemborexant, E2006
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 861 participants (estimated)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Jan 2025 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 20 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort A: Dayvigo-exposed Cohort | – | Other: No InterventionPregnant 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. |
| Cohort B: Comparator-exposed Cohort | – | Other: No InterventionPregnant 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. |
| Cohort C: Untreated Unexposed Comparator Cohort | – | Other: No InterventionPregnant 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. |
Who may qualify
- Ages
- 16 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The study population will include pregnant women with insomnia.
Key inclusion criteria (13 listed)
- 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.
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionThis is a non-interventional study. | Other | Cohort A: Dayvigo-exposed Cohort, Cohort B: Comparator-exposed Cohort, Cohort C: Untreated Unexposed Comparator Cohort |
Primary outcome
Percentage of Live Births Reported With MCM in Women of Cohort A Subset and Cohort C
Time frame: At estimated date of delivery (EDD)/pregnancy outcome (up to 1 year 10 months)
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.
Percentage of Live Births Reported With MCM in Women of Cohort A and Cohort B Subsets
Time frame: At EDD/pregnancy outcome (up to 1 year 10 months)
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.
19 secondary outcomes
Percentage of Live Births and Fetal Losses With MCM in Women of Cohort A and Cohort B Subsets
Time frame: At EDD/pregnancy outcome (up to 1 year 10 months)
Percentage of Live Births and Fetal Losses With MCM in Women of Cohort A Subset and Cohort C
Time frame: At EDD/pregnancy outcome (up to 1 year 10 months)
Percentage of Participants With Spontaneous Abortion (SAB) in Cohort A and Cohort B Subsets
Time frame: From enrollment up to pregnancy outcome (up to 1 year 10 months)
Percentage of Participants With SAB in Cohort A Subset and Cohort C
Time frame: From enrollment up to pregnancy outcome (up to 1 year 10 months)
Percentage of Participants With Stillbirth in Cohort A and Cohort B Subsets
Time frame: From 20 gestational weeks up to pregnancy outcome (up to 1 year 10 months)
Percentage of Participants With Stillbirth in Cohort A Subset and Cohort C
Time frame: From 20 gestational weeks up to EDD/ pregnancy outcome (up to 1 year 10 months)
Percentage of Participants With Preterm Birth in Cohort A and Cohort B Subsets
Time frame: From enrollment up to pregnancy outcome (up to 1 year 10 months)
Percentage of Participants With Preterm Birth in Cohort A Subset and Cohort C
Time frame: From enrollment up to pregnancy outcome (up to 1 year 10 months)
Percentage of Participants With Induced Termination in Cohort A and Cohort B Subsets
Time frame: From enrollment up to date of induced termination (up to 1 year 10 months)
Percentage of Participants With Induced Termination in Cohort A Subset and Cohort C
Time frame: From enrollment up to date of induced termination (up to 1 year 10 months)
Percentage of Infants With Small for Gestational Age (SGA) in Cohort A and Cohort B Subsets
Time frame: At EDD/pregnancy outcome (up to 1 year 10 months)
Percentage of Infants With SGA in Cohort A Subset and Cohort C
Time frame: At EDD/pregnancy outcome (up to 1 year 10 months)
Percentage of Live Births and Fetal Losses With MCM in Women of Cohort A, B and C
Time frame: At EDD/pregnancy outcome (up to 1 year 10 months)
Percentage of Participants With SAB in Cohort A, B and C
Time frame: From enrollment up to pregnancy outcome (up to 1 year 10 months)
Percentage of Participants With Stillbirth in Cohort A, B and C
Time frame: From 20 gestational weeks up to EDD/ pregnancy outcome (up to 1 year 10 months)
Percentage of Participants With Preterm Birth in Cohort A, B and C
Time frame: From enrollment up to pregnancy outcome (up to 1 year 10 months)
Percentage of Participants With Induced Termination in Cohort A, B and C
Time frame: From enrollment up to date of induced termination (up to 1 year 10 months)
Percentage of Infants With SGA in Cohort A, B and C
Time frame: At EDD/pregnancy outcome (up to 1 year 10 months)
Number of MCM From Postmortem With Non-live Birth in Cohort A and Cohort B
Time frame: From enrollment up to pregnancy outcome (up to 1 year 10 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
- Individual participant dataSharing planned: Yes. Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Initiation and Maintenance Disorders and Pregnancy, run by Eisai Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Live Births Reported With MCM in Women of Cohort A Subset and Cohort C (time frame: At estimated date of delivery (EDD)/pregnancy outcome (up to 1 year 10 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.