This is a North American registry sponsored by AbbVie Inc. for pregnant women. Some women taking part in this registry will have taken Orilissa® (elagolix) during early pregnancy, before realizing they were pregnant. Other women taking part will not have taken Orilissa when they became pregnant but will have endometriosis. The purpose of this pregnancy registry is to learn more about the health of pregnant women who have received Orilissa and the health of their babies, compared with those who have not received Orilissa. Women can help by sharing their experiences throughout their pregnancy and information onthe health of their babies until they are 12 months old.
You will be contacted by a registry representative when you join the registry, and then once during each trimester of your pregnancy. After you have given birth, you will be contacted about 4 weeks after your delivery and again when your baby is 6 and 12 months old. Your healthcare providers will also be contacted 2 times during your pregnancy, and after you deliver. Your baby’s healthcare provider will be contacted when your baby is 6 and 12 months old. You will not be asked to attend extra visits at a healthcare provider’s office, change anything you usually do, or change any treatments that you currently receive for the duration of your participation in the registry.
If you would like 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.
This registry is a research study. For the protection of all participants, research studies are reviewed by an Institutional Review Board (IRB). An IRB is a group of scientific and non-scientific individuals who perform an ongoing ethical review of the registry with the participant’s rights and welfare in mind. An IRB has approved this study. The consent form (also approved by the IRB) that the registry representative will read and review with you, explains the study in detail and lets you know your rights. It also outlines your role as a participant in the study. You will be provided with a copy of the consent form.
The BLOOM Pregnancy Registry has been set up to collect information from pregnant women who have taken Orilissa® (elagolix) during pregnancy, and/or who have endometriosis. By sharing your experience, you could help doctors to better understand if Orilissa has any effect on pregnancy, delivery, or the baby for other women who may be taking it when they became pregnant.
No. Participation in this registry does not offer direct access to any medical services or advice. It also does not endorse or provide any healthcare product or service. If you have any questions about your healthcare, please talk to your healthcare provider.
Women with endometriosis who are pregnant and have received Orilissa® (elagolix) at any time during pregnancy may be eligible. You may also join the registry if you have endometriosis, are pregnant but have not received Orilissa. Your eligibility for participation will be confirmed by a registry representative before you join the registry.
After you decide that you want to join the BLOOM pregnancy registry and give your verbal informed consent, you will need to answer a few questions to see if you are eligible for participation.
If you are eligible to take part, you will be asked to provide additional information about yourself, your health and your pregnancy. You will be contacted when you first consent to be a part of the registry, and then once during each trimester of your pregnancy. After you have given birth, you will be contacted about 4 weeks after your delivery and when your baby is 6 and 12 months old. Your healthcare providers will also be contacted after you consent to be part of the registry, 2 times during your pregnancy, and once after your delivery. Your baby’s healthcare provider will be contacted when your baby is 6 and 12 months old. You will not be asked to attend extra visits at a healthcare provider’s office, change anything you usually do, or change any treatments that you currently receive for the duration of your participation in the registry.
If you join this registry, your involvement will last for the duration of your pregnancy and until your baby is at least 12 months old.
Your initial telephone interview upon consenting for the registry may last approximately 45 minutes. The follow-up telephone calls that will be made once per trimester and after your delivery will last approximately 10–15 minutes each.
There is no cost to you for joining the registry. Please check with your service provider about any charges that may be associated with receiving text messages if you decide you want to receive text message reminders from the registry team.
You will not be paid for taking part in the registry.
Although it is a good idea to notify your healthcare provider about your participation in the registry, their permission is not required. As part of your agreement to be in the study, you will give your and your baby’s healthcare providers permission to share information about you and your baby.
We must collect your personal contact information so that we can send you emails and call you to complete the telephone assessments. Your personal contact information will be stored separately from your medical information. This means that researchers reviewing the data will not have access to your personal contact information.
We will use your information for research purposes. We will collect information about your identity, health, and the health of your baby. The information you provide may help researchers gain insight into the use of Orilissa® (elagolix) during pregnancy.
The information you provide in telephone interviews will not be associated with your name, your baby’s name, or your contact details. Your personally identifying information will not be shared with AbbVie Inc., the Sponsor of this registry. In any presentation of results from this registry, your identity will remain anonymous and confidential. The information is expected to be kept for 15 years after the completion of the registry, and may be kept for longer.
Your participation in this registry is voluntary; you may withdraw your consent at any time. If you decide you no longer want to participate, please contact us on the registry’s toll-free number
Please contact your healthcare provider with any questions about your pregnancy.
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