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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nifurtimox (BAYA2502).
- Who it may be relevant to
- Registry conditions: Chagas Disease. Basic parameters: No limits · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Argentina, Bolivia, Chile, Colombia +7
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Drug Nifurtimox (BAYA2502)
At least 1 dose of nifurtimox
Primary outcome measures
- Major Congenital Malformations (birth defects) [Time frame: Up to pregnancy week 40]
Secondary outcome measures (12)
- Events of Interest in Neonates and Infants through 12 Months of Age: Hospitalizations for serious illness [Time frame: Up to 12 months of age]
- Events of Interest in Neonates and Infants through 12 Months of Age: Medications [Time frame: Up to 12 months of age]
- Events of Interest in Neonates and Infants through 12 Months of Age: Growth and development milestones [Time frame: Up to 12 months of age]
- Events of Interest in Neonates and Infants through 12 Months of Age: Neonatal or infant mortality [Time frame: Up to 12 months of age]
- Maternal Complications: Premature rupture of membranes (PROM) [Time frame: Up to pregnancy week 40]
- Maternal Complications: Preeclampsia [Time frame: Up to pregnancy week 40]
- Maternal Complications: Severe pregnancy-induced hypertension (PIH) [Time frame: Up to pregnancy week 40]
- Maternal Complications: Proteinuria [Time frame: Up to pregnancy week 40]
- Maternal Complications: Gestational diabetes [Time frame: Up to pregnancy week 40]
- Maternal Complications: Measures of fetal growth deficiency (small for gestational age) [Time frame: Up to pregnancy week 40]
- Spontaneous abortion [Time frame: Up to 20 weeks]
- Elective/Induced abortion [Time frame: Up to pregnancy week 40]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Many Locations — Multiple Locations
Argentina · 1 center
- Many Locations — Multiple Locations
Bolivia · 1 center
- Many Locations — Multiple Locations
Chile · 1 center
- Many Locations — Multiple Locations
Colombia · 1 center
- Many Locations — Multiple Locations
El Salvador · 1 center
- Many Locations — Multiple Locations
Germany · 1 center
- Many Locations — Multiple Locations
Guatemala · 1 center
- Many Locations — Multiple Locations
Honduras · 1 center
- Many locations — Multiple Locations
Mexico · 1 center
- Many Locations — Multiple Locations
Spain · 1 center
- Many Locations — Multiple Locations
Uruguay · 1 center
- Many Locations — Multiple Locations
Identifiers
NCT: NCT05477953 · 21944