Join the ICP Care Patient Registry for Intrahepatic Cholestasis of Pregnancy today! Since ICP is a rare disease, the more participants who share their pregnancy journey, the more we can learn to improve care, needs and support. Read more about the registry below and sign up if you would like to help support this mission.
What is the Patient Registry?
The registry is an online collection of information submitted by patients who have had a pregnancy affected by Intrahepatic Cholestasis of Pregnancy. The registry is a secure online platform that follows all HIPAA regulations. The information will remain in the secure registry. In the future, if researchers want to use the data from the registry, it will be de-identified (anonymous) meaning no identifying information ever leaves the secure platform including your name, date of birth, address or phone number.
The patient registry is open and available internationally. The platform and questionnaires are available in Spanish and English.
What will I be asked to do if I join?
The website below includes a detailed description of the registry. This includes all the information we collect, how we use it and our promise to keep identities and information secure for those who participate.
Participation is always voluntary and you can choose to stop or cancel your participation at any point.
When you join, you will be required to sign an online consent form.
Next you will be provided with a series of questionnaires about your pregnancies and their outcomes, your past medical history, your family history and any emotional aspects that ICP has had on your life. Each survey should take about 30 minutes to complete. You can stop at any point and return to finish the surveys on your own time.
With each questionnaire, there is an option to upload laboratory information such as liver function testing or bile acid testing into the secure database. The collection of this information is important in forming conclusions that link test results to risks with certain levels of bile acids.
There will be a request to update your medical history with a yearly survey and to complete a survey for any further pregnancies. This will allow researchers to help determine the long term health effects of ICP.
Why do we need a registry?
ICP is a rare disorder with some physicians only seeing a few cases in their entire career. Because it is a rare disorder, much of the guidance and information that we have is based on small studies with very few participants. Your participation in this registry will contribute invaluable data to the medical research community and help broaden the knowledge and understanding of this disease. This in turn, will help answer questions about proper care with a goal of preventing complications in future patients. To do this, we need to have large amounts of data. With rare disorders such as ICP, the most productive way to collect this data is through a patient registry.
The registry will eventually connect directly with researchers studying Intrahepatic Cholestasis of Pregnancy. By building a network of researchers, we hope to make great strides in the progress of treatment.
At present, there is no ideal medication that can prevent stillbirth, but trials are currently being conducted on new medications. As a participant in this registry, will have a connection to information on new advances and opportunities to be involved in further research if you choose.
We follow the following guidelines to ensure your information is kept safe:
Privacy: The registry is being launched on a secure site that is compliant with all regulations including HIPAA. Your data will remain on this site and no identifying information will ever be accessible or shared. This site is created and managed through a company who specializes in patient registries and keeping data secure.
Patient driven: This means that you have a choice every step of the way to participate. You decide how much information is provided and what medical information you share. Registering is not a permanent commitment. You can choose to stop participating at any point. All personal information (including email) will never be shared with researchers. As a participant you can choose to connect directly with those currently conducting research on ICP. You are always in control.
Progress: With rare disorders, progress and advances in the medical community rely greatly on the information generously supplied by those with the condition. The data collected by this registry will help improve the standard of care for all ICP patients.
Patient experience: We want you to have a voice in sharing your patient experience with the world. We will be adding more surveys in the future, focusing on the emotional and psychological aspects of ICP to help spread awareness that ICP is so much more than just an itch.
Frequently Asked Questions
Will joining the registry affect my care in my pregnancies?
No, this registry simply gathers data about your pregnancies and does not alter or affect your medical care.
What information is being gathered?
- Questionnaires for medical, family and pregnancy histories
- Lab results such as bile acid testing and liver function testing
- Medical records from the hospital where delivery took place
- Prenatal records
Can I participate if I live outside of the United States?
Yes! This is an international registry with enrollment available in many countries. Currently the registry is limited to English and Spanish. Fluency in one of these languages is needed to enroll.
Can I participate if I am under 18?
No. You must be over the age of majority in your state or country to sign up for the registry.
What will I be asked to do?
The main portion of the registry will consist of several surveys. There will be an initial survey on your past medical history and current health. Next there will be a survey for each of your pregnancies. At any point you can save your progress and return to complete those surveys at a later date.
There will be a yearly request to provide an update on your medical history and any new pregnancies. This will include an option to upload some of your laboratory reports and other medical records of your choosing.
What should I gather before I sit down to fill out the surveys?
We are hoping to gather medical record data, especially bile acid levels. If you have access to and can make copies of your lab results through a patient portal such as Quest or Labcorp, that information to upload would be very helpful to anyone conducting medical research.
The main results requested would be Bile Acid Levels (total or fractionated) and Liver Function Tests (CMP or comprehensive metabolic profile). You can also contact your medical provider and see if they are able to provide these lab results. We know this is an extra step, but those additional efforts would be invaluable to researchers.
It may also be useful to take some quick notes on each of your pregnancies before you sit down to complete the surveys. We know the more time that goes by after our pregnancies, the more likely it can be for us to forget some of the details. Taking some time to think about each pregnancy before starting the survey may help you recall more details.
Who do I contact with questions about the registry?
Can insurance companies see my information?
No. This is a private patient registry that is hosted on a HIPAA compliant platform. Only the ICP Care Registry team would have access to identifying data about you. Any information that is shared with outside researchers will be de-identified meaning that it cannot be linked to you or your name. No information will be shared with insurance companies.
What are the risks?
Privacy and confidentiality will be protected by using a platform that is secure with limited access. There is always a small chance that there could be a breach of the registry allowing for the loss of confidentiality. The registry is hosted by a company that has expertise in maintaining confidential medical records and registries and every step will be taken to ensure that this risk is minimal.
Can I quit the registry once I join?
Yes, you can quit the registry at any point by sending an email.
Why do we need a registry?
Because ICP is a rare disease, researchers are unable to answer many questions about the disorder that could help optimize care and prevent complications. By gathering data from many different patients, researchers will hopefully be able to improve care for future patients with Intrahepatic Cholestasis of Pregnancy. ICP Care is a 501(c)(3) organization that is dedicated to improving care for patients with ICP and we have a unique ability to be able to connect patients with the disorder to researchers who can join this cause.
Help improve ICP management and research by registering today! We need your support and your voice to help learn more about ICP.
Fight the Itch, Save a life!
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