The Nuvigil and Provigil Pregnancy Registry

Study Overview
=================
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.

Official Title
-----------------
The Nuvigil (Armodafinil) Tablets [C-IV]/Provigil (Modafinil) Tablets [C-IV] Pregnancy Registry

Conditions
-----------------
Narcolepsy, Obstructive Sleep Apnea, Shift Work Sleep Disorder

Intervention / Treatment
-----------------
* Drug: Modafinil/armodafinil


Participation Criteria
=================
Eligibility Criteria
-----------------
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.
Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prospective Cohort<br>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). | Drug: Modafinil/armodafinil<br> <br> * Other names: Nuvigil;|
| Retrospective Cohort<br>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 test. | Drug: Modafinil/armodafinil<br> <br> * Other names: Nuvigil;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of major birth defects | Major birth defects using Metropolitan Atlanta Congenital Birth Defects Program (MACDP) definitions | End of pregnancy through the first year after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 fetal death (defined as >=20 weeks gestation |  | Baseline and End of pregnancy | 
| Incidence of neurodevelopmental problems |  | Baseline and End of pregnancy | 
| Incidence of Microcephaly |  | 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 | End of pregnancy | 
| Incidence of intrauterine growth restriction (IUGR) | defined as observed fetal weight or birth weight below the 10th percentile for gestational age | End of pregnancy | 
| Incidence of Low/very low birth weight (LBW/VLBW) | Defines as - Low birth weight: <2500 g, regardless of gestational age and - Very low birth weight: birth weight <1500 g, regardless of gestational age | End of pregnancy | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pregnancy