The BLOOM Pregnancy Registry (NCT04464187), sponsored by AbbVie Inc., was created to collect information about the possible effects of elagolix-containing medications, like ORIAHNN® (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules), on pregnancy, delivery, and the health of infants. Information from the following 2 groups will be evaluated:
If you have a patient who is interested in learning more about the registry and agrees to be contacted by a registry representative, please register their interest now using the button below.Register a Patient View eligibility criteria
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 a medication containing ORIAHNN should stop taking it right away and call their healthcare provider.
If you have been given login details for the healthcare provider section of this website, please enter them below. You will receive login details when one of your patients is registered.
The BLOOM Pregnancy Registry was established to help determine the frequency of major congenital malformations at birth and through the first year of life in infants of women who were exposed to an elagolix-containing medication during pregnancy.
Literature suggests that uterine fibroids may affect more than half of women under 50 years.1 Many of the available treatments taken by women with uterine fibroids, ORIAHNN® (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules) included, are not approved for use during pregnancy.2,3 Often, the effect of these medications or treatments on pregnancy, or the health of an unborn infant, is not known because pregnant women are often excluded from research studies.
It is hoped that this registry will help doctors to better understand if ORIAHNN has any effect on pregnancy, delivery, or the health of infants, since women may have taken ORIAHNN before realizing they were pregnant.
ORIAHNN is contraindicated in women who are pregnant. Exposure to ORIAHNN early in pregnancy may increase the risk of early pregnancy loss.
Information about this registry is available at clincialtrials.gov (NCT04464187). You may also search for ORIAHNN on the US Food and Drug Administration (FDA) pregnancy exposure registries website.
Please call a registry representative at 1-(833)-782-7241 for more information
Your patient is potentially eligible to participate in this registry if she is pregnant, and:
As the HCP of a study participant, you will be contacted:
As the HCP of a participant’s infant, you will be contacted when the infant is about:
At each contact point, you or your staff will be requested to:
The worksheets should take no more than 10–15 minutes to complete. The information requested will be obtained from your patient’s medical record.
If your patient consents and is eligible to take part, she will be asked to share information on her health, lifestyle, and pregnancy, and will be contacted:
At each time point, your patient will be asked to confirm her contact information.
You will not be compensated for your time. However, the information that you provide will help us learn more about the possible effects of ORIAHNN on pregnancy, delivery, and the health of infants whose mothers were exposed to ORIAHNN during pregnancy. In the future, it is hoped that the results of the registry will help you and your colleagues, along with your patients, make more informed decisions about the use of ORIAHNN.
Women who join the BLOOM Pregnancy Registry will provide a release of information form that will allow the Registry Coordinating Center to contact their healthcare providers. These contacts are necessary to obtain information on the participant’s pregnancy and delivery, and/or the health of her infant.
When asked by the Registry Coordinating Center (RCC), please download, complete, and submit the applicable worksheet for your patient by fax 1-(833)-318-1043 or email to BloomPregnancyRegistry@IQVIA.com .
For the latest important safety information, please refer to the full Prescribing Information.
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