An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About the Risk of Pregnancy Complications and About the Mother's and Baby's Health

Launched by BAYER · Jul 26, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the safety of a drug called nifurtimox in pregnant women who have Chagas disease. Chagas disease is caused by a parasite and can lead to serious health problems if not treated. Nifurtimox has been used for many years to treat this disease, but it’s not recommended for pregnant women because animal studies suggest it might harm the baby. However, we don’t know yet if it has the same effects in humans, so researchers want to gather more information about its safety during pregnancy.

To do this, the trial will collect data from women who have taken nifurtimox while pregnant. This includes looking at any birth defects, pregnancy outcomes (like whether the baby was born healthy, premature, or had other issues), and health problems in both the mother and baby up to one year old. Women who have taken at least one dose of nifurtimox during their pregnancy can participate. The study will last for about 10 years, and participants can expect to share information through phone calls or medical records. This research aims to help us understand the risks involved and improve health outcomes for mothers and their babies.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Females exposed to at least 1 dose of nifurtimox at any time during pregnancy (i.e., from the first day of the last menstrual period / time of conception to pregnancy outcome).
• • Written informed consent (for adolescents under the age of majority, written informed assent by the pregnant minor (where applicable) and written informed consent by the parent/legal guardian).
• Exclusion Criteria:
• • None