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Pregnancy outcome after maternal exposure to modafinil or armodafinil – a collaborative case series by the European Network of Teratology Information Services (ENTIS)

Pregnancy outcome after maternal exposure to modafinil or armodafinil – a collaborative case series by the European Network of Teratology Information Services (ENTIS)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00021107
Enrollment
150
Registered
2020-06-18
Start date
2020-04-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Q89.9

Interventions

Group 1: Pregnant patients with modafinil exposure at any time during pregnancy. Data were prospectively and systematically documented by participating centres of the European Network of Teratology In

Sponsors

European Network of Teratology Information Services (ENTIS), c/o Pharmakovigilanzzentrum Embryonaltoxikologie Charité-Universitätsmedizin
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: All exposed pregnancies, which were documented since 1992, will be included in the analysis, if the estimated date of birth is before August 1st, 2019, and if sufficient follow-up data on pregnancy/neonatal outcome is available. Exposure is defined as any exposure with modafinil (or armodafinil) during pregnancy, beginning at 2+0 weeks after LMP (last menstrual period).

Exclusion criteria

Exclusion criteria: None.

Design outcomes

Primary

MeasureTime frame
The primary objective is to evaluate the rate of major birth defects and pregnancy loss (spontaneous abortions, stillbirths, elective terminations of pregnancy) after first trimester exposure to modafinil. Birth defects will be analyzed descriptively to assess whether any specific pattern can be detected.—

Secondary

MeasureTime frame
The secondary objective is to analyze specific neonatal characteristics such as infant growth including head circumference in pregnancies with modafinil exposure at any time during pregnancy.—

Countries

Australia, France, Germany, Israel, Italy, Japan, Netherlands, Spain, Switzerland, Turkey, United Kingdom, United States

Contacts

Public ContactMarlies Onken

Pharmakovigilanzzentrum Embryonaltoxikologie Charité-Universitätsmedizin

marlies.onken@charite.de030450525702

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026