More Information For

Healthcare Providers

What is the Lampit® Pregnancy Registry and why is it important?

Participation in the Pregnancy Registry is entirely voluntary and may be initiated by you or pregnant women themselves. Any woman with Chagas’ disease who has been exposed to Lampit® during her pregnancy, which is defined as any time from the first day of their last menstrual cycle through the end of their pregnancy, is eligible to participate. Women can be actively pregnant or have a known outcome of the pregnancy as long as they were exposed to at least one dose of Lampit® during their pregnancy.

What are the criteria for eligibility?

Participation in the Pregnancy Registry is entirely voluntary and may be initiated by you or pregnant women themselves. Any woman with Chagas’ disease who has been exposed to Lampit® during her pregnancy, which is defined as any time from the first day of their last menstrual cycle through the end of their pregnancy, is eligible to participate. Women can be actively pregnant or have a known outcome of the pregnancy as long as they were exposed to at least one dose of Lampit® during their pregnancy.

How do I report a pregnancy?

If one of your patients is eligible for participation, please inform her about the study and ask her to read and sign an age-appropriate informed consent document. This document contains details about the study and a request to collect personal health information from you as healthcare providers involved in the care of her pregnancy and that of her infant. Patient brochures will also be available upon request for your patients providing the essential information on the pregnancy registry.

What will my patient’s participation involve once she provides consent?

Your patient’s participation in the observational pregnancy study may last throughout her pregnancy and up to one year after her delivery date. Your patient will be contacted once per trimester, at the estimated date of delivery, and when her infant is 3, 6, 9, and 12 months of age to provide basic information about her pregnancy, post pregnancy health and her infant’s health. At each time point your patient will be asked to confirm her contact information.

After my patient provides consent, what will my participation involve?

Your participation as healthcare provider (HCP) will vary depending on if you are treating the patient or infant. As the woman’s obstetric HCP, you will be contacted between the 6^th and 7^th month of the woman’s pregnancy and, again, within 4 weeks after the estimated delivery date. As the pediatric HCP, you will be contacted when the baby is approximately 3, 6, 9, and 12 months old. In order to collect the information, the Pregnancy Coordinating Center will send questionnaires to you, as the appropriate HCP, for completion.

How will the data be collected?

The Pregnancy Coordinating Center is responsible for collecting the study data. All data provided by you and/or your patient will be entered into the study database. The study database will be kept on a secure computer system maintained by the study administrator in accordance with their written security policy. Information about your patient’s health collected while your patient is in the Lampit® Pregnancy Registry will be kept anonymous and any identifying information will not be used.

The success of the pregnancy registry depends on the continued participation of healthcare providers like you. We greatly appreciate your help with identifying pregnancies, and in assisting with the collection of follow-up information during your patient’s participation in the study.