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

Chagas Disease Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05477953
• Other study ID #: 21944
• Status: Not yet recruiting
• Start date: June 30, 2024
• Est. completion date: January 31, 2032

Study information

• Verified date: April 2024
• Source: Bayer
• Contact: Bayer Clinical Trials Contact
• Phone: (+)1-888-84 22937
• Email: clinical-trials-contact[@]bayer.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: January 31, 2032
• Est. primary completion date: January 31, 2032
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Chagas Disease

Intervention

Drug:
• Nifurtimox (BAYA2502)
At least 1 dose of nifurtimox

Locations

Country	Name	City	State
Argentina	Many Locations	Multiple Locations
Bolivia	Many Locations	Multiple Locations
Chile	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
Spain	Many Locations	Multiple Locations
United States	Many Locations	Multiple Locations	West Virginia
Uruguay	Many Locations	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Uruguay,  Argentina,  Bolivia,  Chile,  El Salvador,  Germany,  Guatemala,  Honduras,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Congenital Malformations (birth defects)	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.	Up to pregnancy week 40
Secondary	Events of Interest in Neonates and Infants through 12 Months of Age: Hospitalizations for serious illness		Up to 12 months of age
Secondary	Events of Interest in Neonates and Infants through 12 Months of Age: Medications		Up to 12 months of age
Secondary	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	Up to 12 months of age
Secondary	Events of Interest in Neonates and Infants through 12 Months of Age: Neonatal or infant mortality		Up to 12 months of age
Secondary	Maternal Complications: Premature rupture of membranes (PROM)		Up to pregnancy week 40
Secondary	Maternal Complications: Preeclampsia		Up to pregnancy week 40
Secondary	Maternal Complications: Severe pregnancy-induced hypertension (PIH)		Up to pregnancy week 40
Secondary	Maternal Complications: Proteinuria		Up to pregnancy week 40
Secondary	Maternal Complications: Gestational diabetes		Up to pregnancy week 40
Secondary	Maternal Complications: Measures of fetal growth deficiency (small for gestational age)		Up to pregnancy week 40
Secondary	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.	Up to 20 weeks
Secondary	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.	Up to pregnancy week 40
Secondary	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.	More than 20 weeks gestation or weighing less than 500 grams
Secondary	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).	Prior to 37 completed weeks of gestation
Secondary	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).	Up to pregnancy week 40
Secondary	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 ).	Up to pregnancy week 40

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