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A Study to Assess the Pregnancy Outcome in Women Exposed to Dayvigo® During Pregnancy Compared to an Unexposed Control Population

NCT06744673 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 861

Last updated 2025-06-19

No results posted yet for this 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.

Conditions

  • Sleep Initiation and Maintenance Disorders
  • Pregnancy

Interventions

OTHER

No Intervention

This is a non-interventional study.

Sponsors & Collaborators

  • Eisai Inc.

    lead INDUSTRY

Eligibility

Min Age
16 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-03
Primary Completion
2025-12-30
Completion
2025-12-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06744673 on ClinicalTrials.gov