NCT05046613招募中不适用
A Prospective, Registry-based, Observational Study to Assess Maternal, Fetal and Infant Outcomes Following Exposure to Rimegepant: The Migraine Observational Nurtec Pregnancy Registry (MONITOR)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Pfizer
- 入组人数
- 780
- 试验地点
- 1
- 主要终点
- Major congenital malformation (birth defect)
研究概览
简要总结
The purpose of the study is to evaluate fetal, maternal, and infant outcomes through 12 months of age.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women with migraine exposed to rimegepant: a diagnosis of migraine and at least 1 dose of rimegepant during pregnancy or just prior to pregnancy (up to 3 days prior to conception)
- •Pregnant women with migraine unexposed to rimegepant: a diagnosis of migraine and no exposure to Rimegepant before or during pregnancy
排除标准
- •Women exposed to other calcitonin gene-related peptide (CGRP)antagonists (e.g., ubrogepant), CGRP monoclonal antibodies, or ditans (e.g., lasmiditan) at any time during pregnancy or just prior to pregnancy
研究组 & 干预措施
Pregnant women with migraine exposed to Rimegepant
Pregnant women with a diagnosis of migraine who are exposed to rimegepant at any time during pregnancy or just prior to pregnancy (up to 3 days prior to conception)
干预措施: Rimegepant (Other)
Pregnant women with migraine not exposed to Rimegepant
Pregnant women with a diagnosis of migraine who are not exposed to rimegepant (up to 5 product half-lives prior to conception) but who may be exposed to other products for the treatment/prevention of migraine at any time during pregnancy or just prior to pregnancy
干预措施: Not taking Rimegepant (Other)
结局指标
主要结局
Major congenital malformation (birth defect)
时间窗: Annually beginning April 2022
Healthcare provider report through the registry
次要结局
- Elective termination(Annually beginning April 2022)
- Gestational hypertension(Annually beginning April 2022)
- Spontaneous abortion(Annually beginning April 2022)
- Postnatal growth deficiency(Annually beginning April 2022)
- Eclampsia(Annually beginning April 2022)
- Pre-eclampsia(Annually beginning April 2022)
- Stillbirth(Annually beginning April 2022)
- Minor congenital malformation(Annually beginning April 2022)
- Gestational diabetes(Annually beginning April 2022)
- Preterm birth(Annually beginning April 2022)
- Small for gestational age(Annually beginning April 2022)
- Infant developmental delay(Annually beginning April 2022)
研究者
研究点 (1)
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