Women who have taken at least one dose of ADDYI at any time during their pregnancy, who are willing to provide verbal or electronic consent and a written release of medical records may be eligible to participate. In addition, women who are pregnant, who have never taken ADDYI or who stopped taking ADDYI at least one month before pregnancy and are willing to provide verbal or electronic consent and a written release of medical records, may be eligible to participate.
If you are eligible and decide to participate in this study, you will be asked to provide health information about your pregnancy and your infant's health up to their first birthday.
During the development of pharmaceutical products, women who are pregnant are typically excluded from clinical trials, and therefore, limited information is available on the use of ADDYI during pregnancy.
The information collected in this study will be provided to health regulatory agencies so that other women who become pregnant while being treated with ADDYI can better understand the effects of ADDYI on their pregnancy and their infants.
By participating in this study, you and your infant will provide important information that will help Sprout Pharmaceuticals, Inc. evaluate pregnancy-related health outcomes of women who took at least 1 dose of ADDYI while pregnant and their infant's growth and development up to their first birthday.
Your decision to participate in this study is entirely voluntary. Information about your health while you are enrolled in the Study will be kept strictly confidential and anonymous, and any identifying information will not be used.
BY PHONE - Call the ADDYI Pregnancy Coordinating Center at 855-265-6954 between the hours of 8:00am-5:00pm, M-F Eastern Time
ONLINE - "Click" on the link to Report a Pregnancy [Report a Pregnancy]
After you provide your contact information, a study representative from the Pregnancy Coordinating Center will contact you to answer any of your questions and confirm your eligibility to participate in the Study. If you prefer you may also ask your healthcare provider to refer you to the Study.
If you are eligible and would like to participate in the Study, a study representative will ask for your verbal or electronic consent along with a written release of medical records. Your consent acknowledges your understanding of the Study, and your release of medical records allows you and your infant's healthcare information to be collected during the Study.
Once you are enrolled in the Study, a study representative will contact you at select time points to collect pregnancy-related health information. You will be contacted once each trimester and around the time of your estimated delivery date (within two weeks), or when you give birth.
A study representative will also contact your healthcare provider at two time points during the Study: approximately 6 to 7 months for prenatal follow-up and around the time of your estimated delivery date, or when you give birth.
In addition, a study representative will contact your infant's pediatrician at three time points during the Study: when your baby is born, at 6 months of age and 1 year of age.