Narcolepsy, Obstructive Sleep Apnea, Shift Work Sleep Disorder
Conditions
Keywords
pregnancy
Brief summary
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.
Detailed description
Both the prospective and the retrospective data are captured.
Interventions
DRUGModafinil/armodafinil
Sponsors
Cephalon, Inc.
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of major birth defects | End of pregnancy through the first year after delivery | Major birth defects using Metropolitan Atlanta Congenital Birth Defects Program (MACDP) definitions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Microcephaly | End of pregnancy | — |
| Incidence of fetal death (defined as >=20 weeks gestation | Baseline and End of pregnancy | — |
| Incidence of minor birth defects | 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 | Baseline and End of pregnancy | — |
| Incidence of spontaneous abortion (defined as <20 weeks gestation) | Baseline and End of pregnancy | — |
| Incidence of neurodevelopmental problems | Baseline and End of pregnancy | — |
| Incidence of intrauterine growth restriction (IUGR) | End of pregnancy | defined as observed fetal weight or birth weight below the 10th percentile for gestational age |
| Incidence of Low/very low birth weight (LBW/VLBW) | End of pregnancy | Defines as - Low birth weight: \<2500 g, regardless of gestational age and - Very low birth weight: birth weight \<1500 g, regardless of gestational age |
| Incidence of Preterm delivery | End of pregnancy | — |
| Incidence of Preeclampsia/pregnancy-induced hypertension (PIH) | Baseline through End of pregnancy | — |
| Maternal breastmilk feeding practices | End of pregnancy through the first year after delivery | — |
| Incidence of small size for gestational age | End of pregnancy | 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 |
Countries
United States
Outcome results
None listed