Clinical trial NCT05477953: 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Chagas Disease
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2022-07-28
Enrollment: 50
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will actively pursue and attempt to capture all nifurtimox exposures during pregnancy that occur in all countries where nifurtimox is approved to be marketed by Bayer.

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.


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

Primary outcomes:
measure: Major Congenital Malformations (birth defects)
timeFrame: Up to pregnancy week 40
Secondary outcomes:
measure: Events of Interest in Neonates and Infants through 12 Months of Age: Hospitalizations for serious illness
timeFrame: Up to 12 months of age
measure: Events of Interest in Neonates and Infants through 12 Months of Age: Medications
timeFrame: Up to 12 months of age
measure: Events of Interest in Neonates and Infants through 12 Months of Age: Growth and development milestones
timeFrame: Up to 12 months of age
measure: Events of Interest in Neonates and Infants through 12 Months of Age: Neonatal or infant mortality
timeFrame: Up to 12 months of age
measure: Maternal Complications: Premature rupture of membranes (PROM)
timeFrame: Up to pregnancy week 40
measure: Maternal Complications: Preeclampsia
timeFrame: Up to pregnancy week 40
measure: Maternal Complications: Severe pregnancy-induced hypertension (PIH)
timeFrame: Up to pregnancy week 40
measure: Maternal Complications: Proteinuria
timeFrame: Up to pregnancy week 40
measure: Maternal Complications: Gestational diabetes
timeFrame: Up to pregnancy week 40
measure: Maternal Complications: Measures of fetal growth deficiency (small for gestational age)
timeFrame: Up to pregnancy week 40
measure: Spontaneous abortion
timeFrame: Up to 20 weeks
measure: Elective/Induced abortion
timeFrame: Up to pregnancy week 40
measure: Fetal death/Still birth
timeFrame: More than 20 weeks gestation or weighing less than 500 grams
measure: Preterm delivery
timeFrame: Prior to 37 completed weeks of gestation
measure: Live Birth
timeFrame: Up to pregnancy week 40
measure: Ectopic or Molar Pregnancy
timeFrame: Up to pregnancy week 40
Other outcomes:
Locations:
city: Multiple Locations
country: United States
facility: Many Locations
state: West Virginia
city: Multiple Locations
country: Argentina
facility: Many Locations
city: Multiple Locations
country: Bolivia
facility: Many Locations
city: Multiple Locations
country: Chile
facility: Many Locations
city: Multiple Locations
country: El Salvador
facility: Many Locations
city: Multiple Locations
country: Germany
facility: Many Locations
city: Multiple Locations
country: Guatemala
facility: Many Locations
city: Multiple Locations
country: Honduras
facility: Many locations
city: Multiple Locations
country: Spain
facility: Many Locations
city: Multiple Locations
country: Uruguay
facility: Many Locations
Study officials:
References: