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
Observational Pregnancy Safety Study of Women Exposed to Nifurtimox During Pregnancy to Describe the Risk of Pregnancy and Maternal Complications and Other Events of Interest on the Developing Fetus, Neonate, and Infant
1 other identifier
observational
50
12 countries
12
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2026
Longer than P75 for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2022
CompletedFirst Posted
Study publicly available on registry
July 28, 2022
CompletedStudy Start
First participant enrolled
June 30, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2032
Study Completion
Last participant's last visit for all outcomes
January 31, 2032
April 17, 2026
April 1, 2026
5.6 years
May 19, 2022
April 16, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Major Congenital Malformations (birth defects)
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, to increase the sensitivity of pregnancy study monitoring
Up to pregnancy week 40
Secondary Outcomes (16)
Events of Interest in Neonates and Infants through 12 Months of Age: Hospitalizations for serious illness
Up to 12 months of age
Events of Interest in Neonates and Infants through 12 Months of Age: Medications
Up to 12 months of age
Events of Interest in Neonates and Infants through 12 Months of Age: Growth and development milestones
Up to 12 months of age
Events of Interest in Neonates and Infants through 12 Months of Age: Neonatal or infant mortality
Up to 12 months of age
Maternal Complications: Premature rupture of membranes (PROM)
Up to pregnancy week 40
- +11 more secondary outcomes
Study Arms (1)
Pregnant women exposed to nifurtimox
The study will examine the effects of nifurtimox on fetuses, neonates and infants through 12 months of age who were exposed to nifurtimox in utero and maternal complications of pregnancy in women who were exposed to at least one dose of nifurtimox during pregnancy.
Interventions
Eligibility Criteria
The study will actively pursue and attempt to capture all nifurtimox exposures during pregnancy that occur in all countries where nifurtimox is approved to be marketed by Bayer.
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (12)
Many Locations
Multiple Locations, West Virginia, 26505, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2022
First Posted
July 28, 2022
Study Start (Estimated)
June 30, 2026
Primary Completion (Estimated)
January 31, 2032
Study Completion (Estimated)
January 31, 2032
Last Updated
April 17, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.