Participation in the Study is entirely voluntary and the enrollment process can be initiated by any woman who is pregnant and has taken at least one dose of ADDYI at any time point during their pregnancy or by their healthcare provider. Likewise, women who are pregnant who were not exposed to ADDYI during pregnancy may also be eligible to participate in the Study. Eligible women will be asked to provide verbal or electronic consent and a written release of medical records relevant to the Study prior to enrollment.
Healthcare providers can enroll their patients by visiting the study website www.AddyiPregnancy.com, or by calling the Pregnancy Coordinating Center toll-free number at 855-265-6954, Monday through Friday 8am - 5pm Eastern Time.
Toll-free telephone and fax numbers are available to facilitate patient enrollment, data collection, and data queries. Spontaneous reports of pregnancies may also be reported directly to Sprout Pharmaceuticals, Inc; these reports will be forwarded to the Study for follow-up throughout the pregnancy.Report a Pregnancy
To enroll a patient or to request additional information:
If a woman is eligible to participate in the Study, a study representative will request verbal or electronic informed consent to acknowledge her understanding of the Study. After providing informed consent, eligible women will be sent the Medical Information Release form by their preferred method of contact to sign, date, and return.
If your patients are interested in learning more about the Study, patient brochures are available upon request.
Your patient's participation will begin once they have successfully completed the enrollment process. They will be contacted once during each trimester and around the time of their estimated delivery date or when they give birth.
A study representative will also contact their healthcare provider at two time points during the Study: approximately 6 to 7 months for prenatal follow-up and around the time of their estimated delivery date, or when they give birth.
In addition, a study representative will contact their infant's pediatrician at three time points during the Study: when their baby is born, at 6 months of age and 1 year of age.
Your participation in the Study as a healthcare provider will vary depending on if you are treating the patient or infant. If you are the woman's obstetrician you will be contacted between the 6th and 7th month of your patient's pregnancy and, again, at the time of their estimated delivery date (within 2 weeks), or when a live birth occurs. If you are the infant's pediatrician you will be contacted when the baby is born, at approximately 6 months and again at 1 year of age. A study representative will contact you via email or phone to collect the necessary information and send questionnaires at the appropriate study timepoints for you to complete.
The Pregnancy Coordinating Center is responsible for collecting and maintaining all the Study data in accordance will all laws and applicable regulations. All data provided by you and/or your patient will be captured on a case report form. The case report form will be kept in a secure location by the study administrator in accordance with their written security policy. Information about your patient and their infant's health collected during the Study will be kept anonymous and any identifying information will not be used.
The success of the Study depends on the continued participation of healthcare providers like you. We greatly appreciate your help with identifying and enrolling patients in the Study, and in assisting with the collection of follow-up information during your patient's participation in the Study.