The BLOOM Pregnancy Registry was created to collect information about the possible effects of medications containing elagolix, such as ORIAHNN® (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules), on pregnancy, delivery, and the health of babies.
The registry is looking for volunteers who were prescribed ORIAHNN by their doctor, but became pregnant while taking it. This registry is also looking for volunteers who are pregnant and have uterine fibroids. If you have uterine fibroids, you do not need to have taken ORIAHNN to take part in this registry. By sharing your experience, you could help doctors to better understand the possible effects of elagolix-containing medications on pregnancy, delivery, and the health of babies.
The BLOOM Pregnancy Registry will evaluate the pregnancy outcomes of the following 2 groups:
Participants will be followed throughout their pregnancy and 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, pregnant women who are exposed to ORIAHNN in the future may have more information about how their pregnancies and babies may or may not be affected.
Important Safety Information: ORIAHNN should not be taken by women who are pregnant or trying to become pregnant as they may increase the risk of early pregnancy loss. Women who become pregnant while taking ORIAHNN should stop taking it right away and call their healthcare provider.
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 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 uterine fibroids (if different than your regular obstetrician), and your baby’s healthcare provider. They will collect information about your general health, your 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:
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.
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