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

Study identification

• EU PAS number:
  EUPAS1000000884
• Study ID:
  1000000884
• Official title and acronym:
  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
• DARWIN EU® study:
  No
• Study countries:
  Argentina

  Bolivia, Plurinational State of

  Chile

  El Salvador

  Germany

  Guatemala

  Honduras

  Mexico

  Spain

  United States

  Uruguay
• Study description:
  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.
• Study status:
  Planned

Research institutions and networks

Institutions

Bayer AG

Study timelines

Date when funding contract was signed

Planned:24/01/2022

Study start date

Planned:30/06/2026

Date of final study report

Planned:01/12/2032

Sources of funding

Pharmaceutical company and other private sector 

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

NCT05477953