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 type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Congenital Chagas disease

Population studied

• Short description of the study population:
  Women with Chagas’ disease who have been exposed to at least 1 dose of nifurtimox during the defined pregnancy exposure window and fetuses, neonates, and infants through 12 months of age who were exposed to at least one dose of nifurtimox in utero
• Special population of interest:
  Pregnant women

Study design details

• Study design:
  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.
• Main study objective:
  To collect and describe:; • selected fetal/neonatal/infant outcomes (i.e., major congenital malformations (MCM), small for gestational age, and postnatal growth and development) at birth and through up to the first year of life of infants born to women exposed to nifurtimox during the defined pregnancy exposure window.; • pregnancy outcomes of interest (i.e., live birth, spontaneous abortions, stillbirths, elective abortions, and preterm births) and pregnancy complications in women with Chagas disease exposed to nifurtimox during the defined pregnancy exposure window.
• Comparators:
  Not applicable
• Outcomes:
  • Pregnancy outcomes:; o Spontaneous abortion ; o Elective abortion; o Fetal death/still birth ; o Preterm delivery ; o Live birth. ; • MCM identified in the developing fetus, neonate or infant,; • Other events of interest identified in the developing neonate and infant,; o Hospitalizations ; o Growth and development milestones as described by the Centers for Disease Control and Prevention (1); o Neonatal or infant mortality; o Diagnosis of congenital Chagas’ disease; • Maternal complications of pregnancy, ; o Premature rupture of membranes; o Preeclampsia; o Severe pregnancy induced hypertension; o Proteinuria; o Gestational diabetes; • Measures of fetal growth deficiency (small for gestational age);
• Data analysis plan:
  Statistical analyses will be of explorative and descriptive nature. The study is not intended to test pre-defined statistical hypotheses.