The Nuvigil and Provigil Pregnancy Registry

Cephalon, Inc.191 enrolled

Overview

The primary objective of the Nuvigil/Provigil Pregnancy Registry is to characterize the pregnancy and fetal outcomes associated with Nuvigil and Provigil exposure during pregnancy.

Both the prospective and the retrospective data are captured.

Study Type

OBSERVATIONAL

Enrollment

191

Conditions

Narcolepsy Obstructive Sleep Apnea Shift Work Sleep Disorder

Interventions

Modafinil/armodafinilDRUG

Eligibility

Sex: FEMALEHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Reported exposure to brand or generic formulations of Nuvigil (armodafinil) and/or Provigil (modafinil) within 6 weeks prior to becoming pregnant, or during pregnancy * Patients who provide oral or written informed consent. * Infant up to 1 year of age born to a female with maternal exposure to armodafinil and/or modafinil within 6 weeks prior to becoming pregnant or during pregnancy. * Able and willing to provide healthcare professional and secondary contact information, and for the patient herself to be contacted periodically by Registry staff. Exclusion Criteria: * Patients who refuse to provide oral or written informed consent. * Patients not exposed to armodafinil or modafinil within 6 weeks prior to becoming pregnant or during pregnancy. * Infants whose mother was not exposed to armodafinil or modafinil within 6 weeks prior to becoming pregnant or during pregnancy.

Locations (1)

Teva Pregnancy Registry

West Chester, Pennsylvania, United States

Outcomes

Primary Outcomes

Incidence of major birth defects

Major birth defects using Metropolitan Atlanta Congenital Birth Defects Program (MACDP) definitions

Time frame: End of pregnancy through the first year after delivery

Secondary Outcomes

Incidence of minor birth defects

Time frame: End of pregnancy through the first year after delivery

Incidence of elective termination due to identified anomaly/birth defect or increased risk of anomaly/birth defect

Time frame: Baseline and End of pregnancy

Incidence of spontaneous abortion (defined as <20 weeks gestation)

Time frame: Baseline and End of pregnancy

Incidence of fetal death (defined as >=20 weeks gestation

Time frame: Baseline and End of pregnancy

Incidence of neurodevelopmental problems

Time frame: Baseline and End of pregnancy

Incidence of Microcephaly

Time frame: End of pregnancy

Incidence of small size for gestational age

defined as the observed weight of a live born infant or size of a fetus that is lower than expected on the basis of gestational age

Time frame: End of pregnancy

Incidence of intrauterine growth restriction (IUGR)

defined as observed fetal weight or birth weight below the 10th percentile for gestational age

Time frame: End of pregnancy

Data from ClinicalTrials.gov

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