The Nuvigil (Armodafinil) Tablets [C-IV]/Provigil (Modafinil) Tablets [C-IV] Pregnancy Registry
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 191
- 试验地点
- 1
- 主要终点
- Incidence of major birth defects
研究概览
简要总结
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.
详细描述
Both the prospective and the retrospective data are captured.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Prospective Cohort
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).
干预措施: Modafinil/armodafinil (Drug)
Retrospective Cohort
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.
干预措施: Modafinil/armodafinil (Drug)
结局指标
主要结局
Incidence of major birth defects
时间窗: End of pregnancy through the first year after delivery
Major birth defects using Metropolitan Atlanta Congenital Birth Defects Program (MACDP) definitions
次要结局
- 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)
- Incidence of intrauterine growth restriction (IUGR)(End of pregnancy)
- Incidence of Low/very low birth weight (LBW/VLBW)(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)
- 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)