An observational study in Chagas Disease, sponsored by Bayer. Not yet recruiting at 12 sites in 12 countries. Open to female participants. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by Bayer · Observational
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:
The study will run for approximately 10 years.
73 studies on the registry are indexed under Chagas Disease; 5 are open to participants now.
This study's planned enrollment of 50 is below the median of 120 across 21 observational studies indexed under Chagas Disease.
Browse Chagas Disease studies →Bayer is the lead sponsor of 1,674 studies on the registry; 51 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 132 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Nifurtimox (BAYA2502)
At least 1 dose of nifurtimox
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
Time frame: Up to pregnancy week 40
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
Apgar Scale, CDC Growth Calculators, Cognitive Checklists, ASD (autism spectrum disorder) Tool
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
Any loss of a fetus due to natural causes less than 20 weeks gestation as a spontaneous abortion (WHO/CDC/ICBDSR, 2014). If available, data from gross or pathological examination of the abortus or fetus will be evaluated for structural defects.
Time frame: Up to 20 weeks
Elective/Induced abortion
Elective or induced abortion is the termination of pregnancy through medical or surgical procedures (ACOG, 2014) (WHO, 2014) If available, data from gross or pathological examination of the abortus or fetus will be evaluated for structural defects.
Time frame: Up to pregnancy week 40
Fetal death/Still birth
Fetal death or stillbirth refers to fetuses born dead at \> 20 weeks gestation or weighing \> 500 grams. Fetal death occurring \> 20 weeks but less than 28 weeks gestation is considered an early fetal loss. Fetal death occurring \> 28 weeks is considered a late fetal loss (ACOG, 2014). If available, data from gross or pathological examination of the abortus or fetus will be evaluated for structural defects. • The study will make the final classification between fetal death/still birth and spontaneous abortion based on gestational age and weight. If these parameters are not available, the study will accept the classification indicated by the HCP.
Time frame: More than 20 weeks gestation or weighing less than 500 grams
Preterm delivery
Births delivered prior to 37 completed weeks of gestation per 100 births. Gestational age is based on the obstetric estimate of gestation (CDC).
Time frame: Prior to 37 completed weeks of gestation
Live Birth
A live birth refers to a complete expulsion from its mother of a surviving neonate breathing or showing any evidence of life such as a heartbeat, umbilical cord pulsation, or definite movement of voluntary muscles, whether the umbilical cord has been cut or the placenta is attached (WHO, 2014).
Time frame: Up to pregnancy week 40
Ectopic or Molar Pregnancy
Any reported ectopic or molar pregnancy will be sub-classified in the respective pregnancy outcome including induced abortion, live birth, or spontaneous pregnancy loss. CDC National Center for Health Statistics surveillance system (NCHS, 2004 ).
Time frame: Up to pregnancy week 40
Plan to share: No — 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.
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Jan 2032, 61 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.