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

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Brief Title

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

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

Brief 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.
    



Study Type

Observational


Primary Outcome

Major Congenital Malformations (birth defects)

Secondary Outcome

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

Condition

Chagas Disease

Intervention

Nifurtimox (BAYA2502)

Study Arms / Comparison Groups

 Pregnant women exposed to nifurtimox
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

50

Start Date

August 31, 2022

Completion Date

January 31, 2032

Primary Completion Date

January 31, 2032

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
      

Gender

Female

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

, (+)1-888-84 22937, [email protected]

Location Countries

Argentina

Location Countries

Argentina

Administrative Informations


NCT ID

NCT05477953

Organization ID

21944


Responsible Party

Sponsor

Study Sponsor

Bayer


Study Sponsor

, , 


Verification Date

August 2022