Observational Study to Assess Adverse Events When Adult Female Participants Are Treated With Ubrelvy (Ubrogepant) or Qulipta (Atogepant) During Pregnancy
This study is for pregnant women with migraines who are considering or have taken specific migraine medications called Ubrelvy (ubrogepant) or Qulipta (atogepant). Migraine is a common condition causing severe headaches. The main goal is to understand how these medicines affect the health of expectant mothers, their unborn babies, and the children once they are born, up to 12 months of age. Researchers will also look at two other groups: pregnant women with migraine who took neither of these drugs, or who stopped them before becoming pregnant. This will help doctors learn more about the safety of these treatments during pregnancy and assist in making informed choices for future patients.
At a glance
What is this study about?
Migraines can be very challenging, especially during pregnancy when many women worry about how their medication might affect their baby. This research study, called an "observational study," aims to gather important information about two specific migraine medicines, Ubrelvy and Qulipta, when used during pregnancy.
Researchers will carefully follow pregnant women who have migraines and are taking or have taken either Ubrelvy or Qulipta. They will collect information on the health of the mother during pregnancy and the health of the baby from birth up to their first birthday. To get a clear picture, they will also compare these women to two similar groups: pregnant women with migraines who haven't taken these medicines, or who stopped them before becoming pregnant. This approach helps the researchers understand if there are any differences in health outcomes that might be linked to the medications.
By gathering this real-world information, the study hopes to provide clearer guidance for doctors and pregnant women with migraines. The goal is to build our understanding of how these treatments might affect mothers and babies, so that women can make the best decisions about managing their migraines during pregnancy.
Key takeaways
- This study helps understand migraine medicine use in pregnancy.
- It's for pregnant women with migraines in the US or Canada.
- You might be using Ubrelvy, Qulipta, or neither.
- Researchers will track mother and baby health up to one year.
- You continue your usual medical care and medications.
- Your participation helps future pregnant women with migraines.
Who may be eligible?
This study is looking for pregnant women living in the United States or Canada who have been diagnosed with migraines by their doctor. To join, you must be currently pregnant when you enrol in the study.
You could be in one of three groups: you've taken Ubrelvy during your current pregnancy, you've taken Qulipta during your current pregnancy, or you have migraines but haven't taken either Ubrelvy or Qulipta during this pregnancy (or you stopped them well before becoming pregnant).
You can't join if you've taken other similar migraine medications (called "gepants" or "CGRP monoclonal antibodies") around the time you became pregnant or at any point during your current pregnancy. Also, if your pregnancy has already ended and you know the outcome, you won't be able to join this particular study.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I live in the United States or Canada.
- I am currently pregnant.
- My doctor has diagnosed me with migraines.
- I am willing to allow my and my baby's doctors to share health information with the study team.
- I have not taken other similar migraine medications (gepants or CGRP monoclonal antibodies) for a few weeks before or during this pregnancy.
- My pregnancy has not yet ended.
What does participation involve?
If you decide to take part, you will be asked to provide some contact information for yourself and your doctors (for both you and your baby, once born). You would also need to agree to let your doctors share your and your baby's medical information with the study researchers when they ask for it. This helps the researchers understand your medical history and track the health of you and your baby.
The study is observational, which means you will not be given any study medication. You'll continue to take any prescribed medication, like Ubrelvy or Qulipta, as your own doctor has advised. The researchers will simply collect information about your health and your baby's health through medical records. They will track outcomes for you during pregnancy and for your baby's health up to 12 months after birth. The total duration of your participation would therefore be from when you enrol until your baby is one year old.
Potential risks and benefits
Locations (2)
- Iqvia /Id# 266904Verified postcodeDurham, United States· Recruiting
- Ottawa Hospital Research Institute /ID# 280174Verified postcodeOttawa, Canada· Recruiting
Common questions
What is an 'observational study'?
It means researchers will watch and collect information about what naturally happens during your pregnancy without asking you to take any specific treatment or change your usual medical care.
Do I need to take Ubrelvy or Qulipta to join?
Not necessarily. You can join if you've taken one of these drugs during pregnancy, or if you have migraines but haven't taken them (or stopped them before pregnancy).
Will this study change my migraine treatment?
No. You will continue to receive all your medical care and treatments, including for your migraines, exactly as your own doctor recommends.
What information will the study collect?
The study will collect health information about you during your pregnancy and about your baby's health from birth until they are one year old, mainly from your medical records.
Can I leave the study if I change my mind?
Yes, you are free to stop participating in the study at any time, and it will not affect your medical care.
How to find out more
EMPRESS Pregnancy Call Center
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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