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

Not yet recruiting

Conditions: Chagas Disease

Registration Number: NCT05477953

Lead Sponsor: Bayer

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not yet recruiting

Sex: Female

Target Recruitment: 50

Inclusion 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

Exclusion Criteria

Not provided

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major Congenital Malformations (birth defects)

Secondary Outcome Measures

Name	Time	Method
Events of Interest in Neonates and Infants through 12 Months of Age: Hospitalizations for serious illness;Events of Interest in Neonates and Infants through 12 Months of Age: Medications;Events of Interest in Neonates and Infants through 12 Months of Age: Growth and development milestones;Events of Interest in Neonates and Infants through 12 Months of Age: Neonatal or infant mortality;Maternal Complications: Premature rupture of membranes (PROM);Maternal Complications: Preeclampsia;Maternal Complications: Severe pregnancy-induced hypertension (PIH);Maternal Complications: Proteinuria;Maternal Complications: Gestational diabetes;Maternal Complications: Measures of fetal growth deficiency (small for gestational age);Spontaneous abortion;Elective/Induced abortion;Fetal death/Still birth;Preterm delivery;Live Birth;Ectopic or Molar Pregnancy