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NCT05477953 · ClinicalTrials.gov registry record
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
A clinical trial, sponsored by Bayer.
- Not yet
- Registry status
- 50
- Enrollment target
NCT05477953: Clinical Trial study, sponsored by Bayer.
NCT05477953 is a clinical trial that has not yet begun recruiting, run by Bayer. The registered enrollment target is 50 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05477953 has not yet begun recruiting, sponsored by Bayer.
- NOT YET RECRUITING
- Registry status
- 50 participants
- Enrollment target
Study Summary
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.
Primary Outcome
1. any major structural defect diagnosed with signs/symptoms, using the selected major congenital anomalies list extracted from the Birth defects surveillance: a manual, CDC. 2. on a case-by-case basis, through evaluator review and agreement from external advisors (if required), any structural defect (that satisfy criterion 1 or 2) detected in the prenatal evaluation of a pregnancy or in the gross or pathologic examination of an abortus, fetus, or deceased infant will be included, if available,
Interventions
- DRUG Nifurtimox (BAYA2502)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2026-12-31 |
| Est. Completion | 2032-01-31 |
What is known before NCT05477953 opens enrollment
NCT05477953 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 50 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Nifurtimox (BAYA2502) is the first listed.
NCT05477953 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05477953 about?
NCT05477953 is a clinical study titled "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". 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 ma...
What is the current status of trial NCT05477953?
This trial is currently not yet recruiting. The enrollment target is 50 participants. The study started on 2026-12-31. Estimated completion is 2032-01-31.
What interventions are being tested in trial NCT05477953?
The interventions under investigation include: Nifurtimox (BAYA2502) (DRUG).
Who is sponsoring clinical trial NCT05477953?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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