The Nuvigil and Provigil Pregnancy Registry
- Conditions
- NarcolepsyObstructive Sleep ApneaShift Work Sleep Disorder
- Interventions
- Drug: Modafinil/armodafinil
- Registration Number
- NCT01792583
- Lead Sponsor
- Cephalon, Inc.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 191
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Prospective Cohort Modafinil/armodafinil Prospective is defined per protocol: prospective data of pregnancy exposure are data acquired prior to the knowledge of the pregnancy outcome or prior to the detection of a congenital malformation at prenatal examination (e.g. fetal ultrasound, serum markers). Retrospective Cohort Modafinil/armodafinil Retrospective is defined per protocol: retrospective data of pregnancy exposure are data acquired after the outcome of the pregnancy is known or after the detection of a congenital malformation on prenatal examination.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Incidence of minor birth defects End of pregnancy through the first year after delivery Incidence of Microcephaly End of pregnancy 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
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 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 fetal death (defined as >=20 weeks gestation Baseline and End of pregnancy Incidence of neurodevelopmental problems Baseline and End of pregnancy
Trial Locations
- Locations (1)
Teva Pregnancy Registry
🇺🇸West Chester, Pennsylvania, United States