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NCT06744673 · ClinicalTrials.gov registry record
A Study to Assess the Pregnancy Outcome in Women Exposed to Dayvigo® During Pregnancy Compared to an Unexposed Control Population
A clinical trial of Pregnancy and Sleep Initiation and Maintenance Disorders, sponsored by Eisai.
- Active
- Registry status
- 861
- Enrollment target
- 1
- Study location
NCT06744673: Active study of Pregnancy and Sleep Initiation and Maintenance Disorders, sponsored by Eisai.
NCT06744673 is a study of Pregnancy and Sleep Initiation and Maintenance Disorders that is active but no longer recruiting, run by Eisai. The registered enrollment target is 861 participants, roughly in line with the 868-participant average among 191 other Pregnancy trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06744673, a study of Pregnancy and Sleep Initiation and Maintenance Disorders, is active but no longer recruiting, sponsored by Eisai.
- ACTIVE NOT RECRUITING
- Registry status
- 861 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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 great
Conditions Studied
Interventions
- OTHER No Intervention
Study Locations (1)
New Jersey
- Eisai Trial Site #1 - Nutley
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 861 participants |
| Start Date | 2025-01-03 |
| Est. Completion | 2025-12-30 |
What the registry record for NCT06744673 still lists
NCT06744673 is an observational study that tracks outcomes without assigning an intervention. The registered 861 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 868-participant average among 191 other Pregnancy trials with a reported enrollment target.
The record links to 2 conditions, with Pregnancy appearing as the primary indexed condition, and to 1 intervention - of which No Intervention is the first listed.
NCT06744673 reports a single indexed study location in New Jersey.
Frequently Asked Questions
What is clinical trial NCT06744673 about?
NCT06744673 is a clinical study titled "A Study 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 ...
What is the current status of trial NCT06744673?
This trial is currently active not recruiting. The enrollment target is 861 participants. The study started on 2025-01-03. Estimated completion is 2025-12-30.
What conditions does trial NCT06744673 study?
This clinical trial studies the following conditions: Pregnancy, Sleep Initiation and Maintenance Disorders.
What interventions are being tested in trial NCT06744673?
The interventions under investigation include: No Intervention (OTHER).
Who is sponsoring clinical trial NCT06744673?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06744673 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pregnancy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06744673's enrollment target sits among peer trials
861 30th of 191 higher than 162 of 191 other Pregnancy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pregnancy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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