The CRENESSITY Pregnancy Study

What is the CRENESSITY Pregnancy Study?

This CRENESSITY Pregnancy Study was created to collect information about the possible effects of CRENESSITY on pregnancy, delivery, and the health of babies.

The study is looking for volunteers who were prescribed CRENESSITY and took it after becoming pregnant. You do not currently need to be taking the medication to qualify. By sharing your experience, you could help doctors to better understand the possible effects of CRENESSITY on pregnancy, delivery, and the health of babies.

Participants will be followed throughout their pregnancy. Information on the health of participants’ babies will also be collected until the baby is 1 year old.

By joining this study and contributing your information, you may help people and their doctors make more informed decisions about medication use during pregnancy in the future. The findings may help pregnant people exposed to CRENESSITY have more information about how CRENESSITY may or may not affect their pregnancy and baby.

How do I participate?

Fill out the contact form to have a coordinating center representative contact you with more information about this CRENESSITY Pregnancy Study

Under 18? You may still be eligible to participate. Please have an adult contact the study site to inquire about participation.

Call the toll-free number
1-850-753-8802 and speak to a coordinating center representative

Ask your healthcare provider to help you complete the contact form

Can I take part in this study?

You may be able to take part in this study if you are currently or were previously pregnant, and:

  • have been diagnosed with classic congenital adrenal hyperplasia
  • took CRENESSITY at any time during pregnancy (at least 11 days after your last menstrual period or at any time after that).

What will I have to do?

To take part in this pregnancy study, you will first be asked to give electronic informed consent during a telephone interview with a coordinating center representative. You will receive information about the study and what it will involve, have a chance to ask any questions, and decide if you want to take part.

If you decide to take part and electronically give your informed consent, then a coordinating center representative will ask questions to collect some information about you and your pregnancy via telephone.

How many times you will be contacted depends on whether you are still pregnant when you join, how far along in your pregnancy you are, or how old your baby is (if they have already been born). Whether your doctor has been contacted will also affect this number. At most, a coordinating center representative will call you:

  • once each trimester (about every 3 months) during your pregnancy to ask if you have had any changes in your pregnancy, your general health, or the medicines you take
  • about 4 weeks after you give birth
  • when your baby is approximately 3, 6, and 12 months old to ask questions about the baby’s health.

Why and when will my healthcare providers be contacted?

With your permission, a coordinating center representative will contact:

  • the healthcare provider caring for you during your pregnancy
  • the healthcare provider who is treating your congenital adrenal hyperplasia (if different than your regular obstetrician), and
  • your baby’s healthcare provider.

They will collect information about your general health, your pregnancy, and your baby’s health. Following your enrollment a coordinating center representative will contact your healthcare providers a total of up to 7 times. They will ask about your pregnancy, general health, and treatment since the last call. They will call up to:

  • 3 times during your pregnancy
  • 4 times after your delivery.

They will also call your baby’s healthcare provider when your baby is 1, 3, 6, and 12 months old to ask about your baby’s health.

The contact you and your healthcare providers will receive is summarized in the diagram here.

contact-schedule

If you participate in the study, you will not:

  • have any study visits
  • have any medical tests for the study
  • receive any medications for the study.

What else will happen if I participate?

After you enroll in the study, we will send you a welcome message by email. With your consent, we will also send you occasional emails and text messages to remind you about upcoming telephone interviews. You can choose to stop receiving these communications at any time. This will not affect your participation in the study.

Our Privacy Policy contains full details of our commitment to your privacy.

Our FAQs contain answers to many frequently asked questions.