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

Starting soon

Conditions studied: Chagas Disease

In brief

This is an observational study in which data from women with Chagas disease who will take or have already taken nifurtimox during pregnancy and the impact on their babies are studied. Chagas disease is an inflammatory, infectious disease caused by the parasite Trypanosoma cruzi. This parasite is mainly spread by insects called triatomine bug. If Chagas disease is left untreated, it can later cause e.g. serious heart and digestive problems. Nifurtimox has been used for more than 50 years to treat Chagas disease in children and adults. It is not recommended to be used during pregnancy as data from animal studies indicate that it may harm the baby. Currently, there are not enough data to know if this is also the case in humans. In this study, researchers want to collect data on the safety of nifurtimox use in pregnant women. To do this, researchers will collect the following information: * Birth defects (abnormal and problematic structures or functions, a child is born with) * Pregnancy outcomes (like live birth, preterm birth, still birth/death of the unborn baby, miscarriage, or abortion) * Certain health problems of the child up to 12 months of age * Certain health problems of the women experienced during pregnancy The data will be collected from different sources including telephone calls with the women or their doctor, CRFs (case reprt forms) or from medical records The researchers will compare the proportion of children with birth defects, pregnancy outcomes or certain health problems of the child or the women during pregnancy with available data on these outcomes in the general population. The study will run for approximately 10 years.

Key facts

Study ID

NCT05477953

Run by

Bayer

People needed

50

Starts

2026-12-31

Expected to finish

2032-01-31

Last updated by the study team

2026-07-06

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• None

Where it is running

• Many Locations — Multiple Locations, West Virginia, United States
• Many Locations — Multiple Locations, Argentina
• Many Locations — Multiple Locations, Bolivia
• Many Locations — Multiple Locations, Chile
• Many Locations — Multiple Locations, Colombia
• Many Locations — Multiple Locations, El Salvador
• Many Locations — Multiple Locations, Germany
• Many Locations — Multiple Locations, Guatemala
• Many locations — Multiple Locations, Honduras
• Many Locations — Multiple Locations, Mexico
• Many Locations — Multiple Locations, Spain
• Many Locations — Multiple Locations, Uruguay

Full record on ClinicalTrials.gov

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