To comply with protection guidelines for the participants, research studies are reviewed by an Institutional Review Board (IRB), who has approved this study. An IRB is an administrative body that governs the rights and welfare of research subjects recruited for the studies. A safety study representative will assist you in reviewing the consent form, which provides an outline of the study details and describes your role and rights as a participant in the study. A copy of the consent form will be provided to you.
No. Participating in this safety study does not propose any medical services or advice. It also does not provide any healthcare product or service. Please contact your healthcare provider for any related questions.
The initial enrollment call may last around 30- 45 minutes. The follow-up calls that will be made once per trimester will last approximately 10-12 minutes each.
There is no cost to you for joining the safety study.
Participation in the study is voluntary. No compensation will be provided.
It is always advised to notify your healthcare provider about your participation in the study, however, their approval is not required.
Personal contact information is required so that the study representative can send you emails and call you to complete telephone assessments. Your personal contact information will be archived separately from your medical information and researchers assessing the medical data will not have access to your personal contact information.
Your information will be used for research purposes. Information about your identity, health, and the health of your baby will be collected which may help researchers gain knowledge on the use of BREXAFEMME during pregnancy.
Your personal / identifying information will not be shared with the sponsor of this registry. In any presentation of results from this safety study, your identity will remain anonymous and confidential. The information will be deleted from the database at the completion of the study.
Your participation in this safety study is voluntary and you may withdraw your consent at any time. If you decide to no longer participate, please contact the study representative at 1‑888‑982‑7299. You will be asked a brief series of questions in an exit interview to determine the pregnancy status and to document the reason for withdrawal.
Please contact your healthcare provider with any questions about your pregnancy.