The BLOOM Pregnancy Registry is a North American registry for pregnant women who have endometriosis and who may or may not have taken Orilissa® (elagolix) during pregnancy. By sharing your experience, you could help doctors to better understand Orilissa use before and during pregnancy. Doctors have questions about whether it has any effect on pregnancy, delivery, or the health of babies of women who were taking it when they became pregnant. The possible effects will be compared with outcomes for women who were not taking Orilissa when they became pregnant but who also have endometriosis. Participants will be followed throughout their pregnancy; information on the health of participants’ babies will also be collected until the baby is 12 months old.
By joining this registry and sharing your information, in the future, pregnant women who are exposed to Orilissa may have more information about how their pregnancies and babies may or may not be affected.
You may be able to take part in this registry if you are pregnant, and:
To take part in this pregnancy registry, you will first be asked to give verbal informed consent during a telephone interview with a registry representative. This means that you will receive information about the registry and what it will involve, have a chance to ask any questions, and decide if you want to take part.
If you decide to participate and verbally give your informed consent, then a registry representative will:
If you would like to have further information to discuss with a family member or your regular doctor, or to share with others, you can download a copy of the BLOOM Pregnancy Registry Patient Brochure.
With your permission, a registry representative will contact the healthcare provider caring for you during your pregnancy, the healthcare provider who is treating your condition (if different than your regular obstetrician), and your baby’s healthcare provider. They will collect information about your general health during pregnancy and your baby’s health. Following your enrollment, a registry representative will:
The contact you and your healthcare providers will receive is summarized in the diagram below.
If you participate in the registry, you will not need to:
After you enroll in the registry, we will send you a welcome message by email. With your consent, we will also send you occasional emails and text messages to remind you about upcoming telephone interviews. You can choose to stop receiving these communications at any time. This will not affect your participation in the study.
Our FAQs contain answers to many frequently asked questions.
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