NCT05046613
Recruiting
N/A
A Prospective, Registry-based, Observational Study to Assess Maternal, Fetal and Infant Outcomes Following Exposure to Rimegepant: The Migraine Observational Nurtec Pregnancy Registry (MONITOR)
ConditionsMigraine
Overview
- Phase
- N/A
- Intervention
- Rimegepant
- Conditions
- Migraine
- Sponsor
- Pfizer
- Enrollment
- 780
- Locations
- 1
- Primary Endpoint
- Major congenital malformation (birth defect)
- Status
- Recruiting
- Last Updated
- 3 months ago
Overview
Brief Summary
The purpose of the study is to evaluate fetal, maternal, and infant outcomes through 12 months of age.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
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)
Intervention: Rimegepant
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
Intervention: Not taking Rimegepant
Outcomes
Primary Outcomes
Major congenital malformation (birth defect)
Time Frame: Annually beginning April 2022
Healthcare provider report through the registry
Secondary Outcomes
- 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)
Study Sites (1)
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