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NCT Number: NCT05477953

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 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.

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Key information

Conditions

Chagas Disease Euglenozoa Infections Infections Parasitic Diseases Protozoan Infections Trypanosomiasis Vector Borne Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Many Locations, Multiple Locations, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nifurtimox (BAYa2502)

Drug

At least 1 dose of nifurtimox

Primary outcomes

  1. Major Congenital Malformations (birth defects)

    Time frame: Up to pregnancy week 40

    • any major structural defect diagnosed with signs/symptoms, using the selected major congenital anomalies list extracted from the Birth defects surveillance: a manual, CDC.
    • 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

Secondary outcomes

  1. Events of Interest in Neonates and Infants through 12 Months of Age: Hospitalizations for serious illness

    Time frame: Up to 12 months of age

  2. Events of Interest in Neonates and Infants through 12 Months of Age: Medications

    Time frame: Up to 12 months of age

  3. Events of Interest in Neonates and Infants through 12 Months of Age: Growth and development milestones

    Time frame: Up to 12 months of age

    Apgar Scale, CDC Growth Calculators, Cognitive Checklists, ASD (autism spectrum disorder) Tool

  4. Events of Interest in Neonates and Infants through 12 Months of Age: Neonatal or infant mortality

    Time frame: Up to 12 months of age

  5. Maternal Complications: Premature rupture of membranes (PROM)

    Time frame: Up to pregnancy week 40

  6. Maternal Complications: Preeclampsia

    Time frame: Up to pregnancy week 40

  7. Maternal Complications: Severe pregnancy-induced hypertension (PIH)

    Time frame: Up to pregnancy week 40

  8. Maternal Complications: Proteinuria

    Time frame: Up to pregnancy week 40

  9. Maternal Complications: Gestational diabetes

    Time frame: Up to pregnancy week 40

  10. Maternal Complications: Measures of fetal growth deficiency (small for gestational age)

    Time frame: Up to pregnancy week 40

  11. Spontaneous abortion

    Time frame: Up to 20 weeks

    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.

  12. Elective/Induced abortion

    Time frame: Up to pregnancy week 40

    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.

  13. Fetal death/Still birth

    Time frame: More than 20 weeks gestation or weighing less than 500 grams

    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.

  14. Preterm delivery

    Time frame: Prior to 37 completed weeks of gestation

    Births delivered prior to 37 completed weeks of gestation per 100 births. Gestational age is based on the obstetric estimate of gestation (CDC).

  15. Live Birth

    Time frame: Up to pregnancy week 40

    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).

  16. Ectopic or Molar Pregnancy

    Time frame: Up to pregnancy week 40

    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 ).

Study contacts

Contact information is provided by the study sponsor or research team.

Bayer Clinical Trials Contact

CONTACT

[email protected]

(+)1-888-84 22937

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2032
Study completion
2032
First posted
Jul 28, 2022
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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