PREGISTRY INTERNATIONAL PREGNANCY EXPOSURE REGISTRY (PIPER)
What is the PIPER?
The PIPER is a research study that focuses on gathering information. We are asking pregnant women to answer questions about their pregnancies, their health, and their babies’ health. Asking questions and collecting information from pregnant women themselves provides a unique perspective from other studies that rely on doctors or nurses to provide information about their pregnant patients.
The PIPER will ask questions about:
- Your background (such as your age and education level)
- Your pregnancy (such as your expected date of delivery, your weight at various time points and medications you are using)
- Your overall health (such as any pre-pregnancy medical conditions or pregnancy-related problems)
- Your COVID-19 vaccination
- Your current health status
- Your labor and delivery (such as C-section or vaginal birth and length of labor)
- Your baby’s health (such as his or her growth and weight gain)
Researchers will examine the information from the PIPER participants to identify trends, similarities, and differences and to answer research questions regarding pregnancy outcomes.
What is a research study?
A research study is a project that aims to learn more about a specific topic, in this case, pregnancy.
Many research studies collect information about health, medical care, or medical treatments. There are different types of research studies. The PIPER is an observational study, meaning that it is only collecting information (observing the participants). Another type of research study — called a clinical trial — tests whether a new drug or other medical treatment safely and effectively improves patient health. The PIPER is not testing any medical treatments.
What is the PIPER trying to learn?
Using data collected directly from pregnant women, the PIPER is trying to answer questions about pregnancy outcomes.
We hope the PIPER will provide women and health care providers with the information they need to make informed decisions about pregnancy.
What are the benefits of joining the PIPER?
By joining the PIPER and answering questions like those listed earlier, you can help improve care for other pregnant women in the future.
By taking part in the PIPER, you will be able to see how your pregnancy experiences compare to those of other women in the study, since aggregate results of the Registry will be reported to participants.
You and your baby may not benefit directly from joining the PIPER. But giving your health information might help us learn about pregnancy outcomes.
What are the risks of joining the PIPER?
Who is eligible for the PIPER?
The PIPER is open to any woman who is 18 years of age or older and pregnant.
Who is sponsoring the PIPER?
The PIPER is sponsored by Pregistry, LLC.
Who should I contact if I have any questions?
If you have any problems or questions about this study, or about your rights as a research participant, or about any research-related issue, contact the Principal Investigator, Dr. Diego Wyszynski, at PIPER@pregistry.com.
To be eligible to register in the PIPER, you must be:
- 18 years of age or older
- Currently pregnant
- Read and understand the online modules, be willing to sign the inform consent and to enter the answers to some basic questions
If you are not pregnant, please do not register.
The PIPER will be available in other languages in the near future.
Who will see my information?
In general, only the PIPER Principal Investigator and study managers will see your personal information. These individuals are trained to protect study participant privacy and keep data secure. The PIPER will not share your name, address, phone number, or other personal information with anyone else.
In the database, we will replace your name with a code number to hide your identity in the data. Only qualified and approved scientists and researchers will have access to these anonymized data, meaning they will not have access to your name, address, phone number, or other personal information that could reveal your identity. They will study the anonymized information from the PIPER to look for trends or common issues that many women, or certain groups of women, may experience. For instance, they might discover that 40 out of 1,000 PIPER participants reported having severe muscle pain shortly after a certain medication. But they won’t know who any of those women are. The PIPER may also share anonymized information with other databases, registries, and data repositories. Combining the PIPER’s data with other sources may help us expand our knowledge about pregnancy and could lead to new study ideas and future treatments.
Will you tell anyone that I am taking part in the PIPER?
No. The PIPER will not reveal to anyone that you, specifically, are part of the project.
How secure is my information?
The PIPER will maintain all of the information you provide in a safe, secure computer database that conforms with government security requirements, including the Federal Information Security Management Act of 2002 (FISMA, 44 U.S.C. § 3541).
The first step in securing your information is for you to use a password that is difficult for someone to guess and that you do not share with anyone. In addition, if you are accessing the PIPER using a cell phone or other mobile device, having a passcode on your device will improve security of your data. Although we are using many tools and practices to ensure the security of information saved in the PIPER, we cannot guarantee the security of data on your computer or mobile device. We also cannot guarantee the security of data while it is being sent to the PIPER database from your computer or mobile device.
What happens to my information when the PIPER ends?
After the PIPER ends, we will continue to keep the information you provided in a secure database, and your identity will remain protected. Anonymized data—data without participants’ identities or any information that could reveal their identities—from the PIPER will continue to be available for researchers to study for many years after the project ends. The PIPER anonymized data may be requested by doctors, scientists, and other interested parties who want to do their own research on pregnancy and/or who want figure out how many the PIPER participants may be eligible for other research studies.
Who can "sign" the consent form?
Any woman who is pregnant and older than 18 years of age and who can complete the consent form for herself is eligible. Selecting the appropriate prompts in the consent form constitutes an electronic signature of the form and signifies acceptance of the risks and benefits involved in the PIPER.
If you have already joined PIPER, a copy of your signed Consent form is available in Edit Profile.
What if I change my mind about being in the PIPER?
It is your decision to take part in PIPER. You can decide to stop participating at any time: just stop entering information. You do not need to provide a reason for stopping your participation.
To withdraw from the PIPER, you can send an email to the PIPER Coordinators at PIPER@pregistry.com. Please specify in your email whether you want to:
Stop answering PIPER questionnaires and stop receiving the PIPER email reminders and other messages, or
Remove all of your information from the active database. Please keep in mind that we cannot get back any of your data included in de-identified data that was shared before the PIPER received and processed your request for removal.
Can I Register Now?
Yes, you can! Please, click the green button below.