More Information for Women
What is the Lampit® Pregnancy Registry?
Bayer AG, the manufacturer of Lampit®, is conducting an observational study to collect information of women with Chagas’ disease treated with Lampit® while pregnant. Safety data on pregnancy complications, pregnancy outcomes including information on the health of the baby up to 12 months of age are collected.
This is an observational study which means you will continue to receive care as decided by your healthcare provider(s). Your treatment or care will not change in any way as a result of your participation in this study.
Who can participate in the Study?
- Women who were treated with at least one dose of Lampit® for Chagas’ disease at any time during their pregnancy which includes the time starting on day one of their last menstrual cycle, through the end of the pregnancy.
- Women who are actively pregnant or have a known outcome of the pregnancy.
- Women who are able to sign a written informed consent for the study. Women designated as minors will also need a legal guardian to sign written informed consent in addition to the woman.
Why should I participate in this Study?
Your participation is voluntary but will provide important information that may eventually be used by healthcare providers and future pregnant women. The success of the study is dependent upon the participation of eligible women and healthcare providers. Thank you for your time and consideration.
Will my privacy be protected?
All personal and medical information will be kept strictly confidential. Information about your health while you are enrolled in the Lampit® Pregnancy Registry will be kept anonymous and any identifying information will not be used.
How can I learn more?
Live within US:
Call the Pregnancy Coordinating Center at 877-899-1393
Hours of Operation: Monday - Friday
8:00 a.m. to 5:00 p.m. ET
Fax the Pregnancy Coordinating Center at 888-278-9759
Email us at LampitPregnancyRegistry@ubc.com
Live outside the US:
Email us at LampitPregnancyRegistry@ubc.com
By providing your contact information, someone from the Pregnancy Coordinating Center will contact you to confirm the necessary information to complete the registration. You may also ask your healthcare provider to report your pregnancy.
If you are eligible and would like to participate, you will be asked to provide written consent to acknowledge your understanding of the study. This provides your permission for your personal or infant’s healthcare information to be collected. After consent is received, a study representative will also contact your healthcare provider to confirm your personal health information.
What will my participation involve once I provide consent?
Your participation in the study may last throughout your pregnancy and up to one year after your delivery date. You will be contacted once per trimester, at the estimated date of delivery, and when your baby is 3, 6, 9, and 12 months of age to provide basic information about your pregnancy and your infant’s health. At each timepoint you will be asked to confirm your contact information.
You can be actively pregnant or have had a previous pregnancy where you were exposed to Lampit®.