About the CRENESSITY Pregnancy Study
The CRENESSITY Pregnancy Study is a USA observational study of people who are or have been pregnant and have received CRENESSITY at any time during pregnancy. The goal is to collect and describe the frequencies of maternal, fetal, and infant outcomes among people exposed to CRENESSITY at any point from 11 days after their last menstrual period (LMP) or at any time during pregnancy.
It is hoped that this study will help healthcare professionals to better understand if CRENESSITY has any effect on pregnancy, delivery, or the health of babies.
Have questions?
Have questions?
Please call a coordinating center representative at 1-850-753-8802 for more information.
Eligibility Criteria
Your patient may be able to take part in this study if they are currently or were previously pregnant, and:
Consent will be obtained prior to enrollment. Consent will be obtained in compliance with any country-specific regulations or requirements. In particular, for eligible patients less than 18 years of age, consent must be obtained from the patient’s legally authorized representative.
What are my responsibilities as a healthcare provider (HCP)?
As the HCP of a study participant, you will be contacted at most:
- When your patient enrolls
- 3 times during your patient’s pregnancy (at approximately 14, 26, and 34 weeks)
- About 4 weeks after your patient’s delivery
- When the baby is about 3, 6, and 12 months old
As the HCP of a participant’s infant, you will be contacted at most when the infant is about:
- 1 month old
- 3 months old
- 6 months old
- 12 months old
At each contact point, you or your staff will be requested to provide your patient's medical information.
What will my patient have to do once enrolled?
If your patient consents and is eligible to take part, they will be asked to share information about their health, lifestyle, and pregnancy, and will be contacted at most:
- at enrollment
- during each trimester
- within 4 weeks of their estimated date of delivery, following the infant’s birth
- when the infant is 3, 6, and 12 months old.
At each time point, your patient will be asked to confirm their contact information.
Will I be compensated for my time as a healthcare provider?
You will not be compensated for your time. However, the information that you provide will help us learn more about the possible effects of CRENESSITY on pregnancy, delivery, and the health of infants whose mothers were exposed to CRENESSITY at any time during pregnancy. In the future, it is hoped that the results of the study will help you and your colleagues, along with your patients, make more informed decisions about the use of CRENESSITY.
How will the study data be collected and stored?
Participants who join the CRENESSITY Pregnancy Study will provide a release of information form that will allow the study 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 their infant.
The study coordinating center will collect the information provided by the patient and the healthcare providers. The data collected from all parties will be entered in secure electronic systems and the companies who work with the Sponsor may operate these systems. Personal data will be stored for the period requested by local regulations after the end of the study. The health information of the patient and of their infant will be kept anonymous and any identifying information will not be used.
How can I enroll my patient in the study?
Contact the Study Coordinating Center (RCC) or have your patient call at 1-850-753-8802
Assist your patient in filling out the contact form on the website or register your patient’s interest with their consent by clicking the link here
Contact the coordinating center by email: CRENESSITYPregnancyStudy@iqvia.com