EMPRESSSafety of Ubrelvy and Qulipta During Pregnancy
The study aims to observe the safety of taking Ubrelvy and Qulipta during pregnancy by monitoring for major congenital malformations in infants.
Data Collection
Collected from today forward - ProspectiveBrain Diseases+3
+ Central Nervous System Diseases
+ Migraine Disorders
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: January 10, 2023
Actual date on which the first participant was enrolled.This study focuses on understanding the safety of two migraine medications, Ubrelvy and Qulipta, when taken during pregnancy. It looks at how these medications might affect pregnant women, their unborn babies, and the infants after they are born, up to the age of 12 months. The study is important because migraines are common, and understanding the effects of these treatments during pregnancy can help ensure the safety of both mothers and their children. The study includes a total of about 1,884 pregnant women in the United States, divided into three groups: those taking Ubrelvy, those taking Qulipta, and a comparator group not using these drugs. Participants in this study will continue taking their medication as prescribed by their doctors. The study will track and assess any major birth defects or chromosomal issues that may arise in the infants. These outcomes will help researchers understand if the medications have any significant risks during pregnancy. By comparing the health of infants from all three groups, the study aims to provide clear information on the safety of using Ubrelvy and Qulipta during pregnancy.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.1884 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Within the United States or Canada. * Qualify as a prospective enrollment, defined as currently pregnant. * A diagnosis of migraine by the patient's health care provider (HCP). * Provide contact information for the participant and her and her infant(s)', if applicable, HCPs. * Authorize their HCP(s) to release maternal and infant medical information to the registry, upon request. * Provide sufficient information to confirm eligibility for 1 of following: * Ubrelvy-exposed women with migraine: documented information indicating that at least 1 dose of Ubrelvy was taken during pregnancy, including the estimated number of administrations per trimester. * Qulipta-exposed women with migraine: documented information to indicating that at least 1 dose of Qulipta was taken during pregnancy, including start and stop date(s) of administration. * Internal comparator: Ubrelvy/Qulipta-unexposed pregnant women with migraine: documented information indicating that they have, a) never taken Ubrelvy and/or Qulipta, or b) discontinued Ubrelvy 2 days prior or Qulipta 5 days prior to conception. Exclusion Criteria: * Documentation of exposure to any gepants (acute or preventive) other than Ubrelvy and Qulipta, or CGRP monoclonal antibodies, from 5 halflives of the respective treatment prior to conception or at any point during pregnancy before enrollment. * Women who are no longer pregnant (retrospective cases women for whom the pregnancy has already ended, and the outcome of pregnancy is known at the time of enrollment). * For further clarification of inclusion/exclusion please contact the investigator to the end of this section in case anything is unclear to a potential patient, etc
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Ottawa Hospital Research Institute /ID# 280174
Ottawa, Canada