Not yet recruitingOBSERVATIONAL

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

If you have Chagas disease and have taken or will take the medicine nifurtimox during pregnancy, this study might be for you. Researchers want to understand if taking nifurtimox during pregnancy causes any health problems for expectant mothers or their babies. Chagas disease is an infection spread by insects, and nifurtimox has been used to treat it for many years. However, its effects during human pregnancy are not fully known, as animal studies have shown potential risks. This study will collect information on birth defects, pregnancy outcomes, and health issues in both mothers and babies up to one year after birth. The aim is to gather important safety data over about 10 years.

At a glance

Status

Not yet recruiting

Sponsor

Bayer

Enrolment target

Start

30 Jun 2026

Estimated completion

31 Jan 2032

Chagas Disease

What is this study about?

This study is about understanding the safety of a medicine called nifurtimox, specifically when used during pregnancy. Nifurtimox is a treatment for Chagas disease, an infection caused by a tiny parasite usually spread by a type of insect. If Chagas disease isn't treated, it can lead to serious heart and digestion problems later in life.

While nifurtimox has been used for over 50 years to treat adults and children with Chagas disease, doctors usually don't recommend it during pregnancy. This is because studies in animals suggest it might not be safe for the baby. However, there isn't enough information yet to know if the same risks apply to pregnant women and their babies. That's why this study is so important: it aims to collect real-world information to better understand any potential effects.

The researchers will collect details about pregnancy outcomes (like live births, miscarriages, or premature births), whether babies are born with any health problems, and any health issues mothers experience during pregnancy. They will follow the children's health up to 12 months of age. This information, gathered over roughly 10 years, will help doctors give more accurate advice about nifurtimox use during pregnancy in the future.

Key takeaways

This study collects information about nifurtimox use during pregnancy for Chagas disease.
It aims to understand effects on mothers' and babies' health.
No new medication or treatments are given during the study.
Information is collected from medical records and phone calls.
This research helps improve future advice for pregnant women.
You can stop participating at any time.

Who may be eligible?

This study is looking for women who are pregnant or have recently given birth, and who have taken the medicine nifurtimox at any point during their pregnancy. This includes taking it from the very start of pregnancy right up until the baby is born.

To join the study, you'll need to give your permission by signing a consent form. If you are a teenager under 16, you will also need to agree to take part, and your parent or legal guardian will need to give their permission too.

There are no other reasons that would prevent you from being part of this study, as long as you meet these main requirements.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you pregnant or have you recently given birth?
Did you take nifurtimox at any point during your pregnancy?
Are you willing to provide consent to participate?
If you are under 16, will your parent/guardian also give permission?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you won't be given any new medication or treatments. This is an 'observational' study, which means researchers will simply collect information about your health and your baby's health. They will gather this data from sources like telephone calls, forms filled out by you or your doctor, or directly from your medical records. The researchers will be looking at things like your pregnancy outcomes, if your baby has any birth defects or certain health problems, and any health issues you experience during pregnancy. They will continue to collect information about your child's health up to 12 months after birth. The study itself will run for about 10 years in total.

Potential risks and benefits

The main benefit of taking part in this study is helping researchers gather important information about the safety of nifurtimox during pregnancy. This will contribute to a better understanding of the medicine's effects, which can help other pregnant women with Chagas disease in the future. As this is an observational study, you will not be taking any new medication or undergoing new procedures, so there are no additional physical risks from participating. The main potential inconvenience might be the time taken for phone calls or providing information. Remember, you can choose to leave the study at any time without giving a reason, and this will not affect your medical care.

Locations (12)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Many Locations
Unverified
Multiple Locations, United States
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Multiple Locations, Argentina
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Multiple Locations, Bolivia
Many Locations
Unverified
Multiple Locations, Chile
Many Locations
Unverified
Multiple Locations, Colombia
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Unverified
Multiple Locations, El Salvador
Many Locations
Unverified
Multiple Locations, Germany
Many Locations
Unverified
Multiple Locations, Guatemala
Many locations
Unverified
Multiple Locations, Honduras
Many Locations
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Multiple Locations, Mexico
Many Locations
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Multiple Locations, Spain
Many Locations
Unverified
Multiple Locations, Uruguay

Common questions

What is Chagas disease?

Chagas disease is an infection caused by a parasite, usually spread by an insect. If not treated, it can lead to serious heart and digestion problems.

What is nifurtimox?

Nifurtimox is a medicine that has been used for many years to treat Chagas disease in adults and children.

Why don't doctors recommend nifurtimox during pregnancy?

Animal studies have suggested it might not be safe for the baby, but there isn't enough information about its effects in human pregnancy yet.

Will I have to take any new medicines if I join this study?

No, this study only collects information. You will not be given any new medicines as part of this research.

How long will I be involved in the study?

Researchers will collect information about your child's health up to 12 months after birth. The overall study will run for about 10 years.

How to find out more

Bayer Clinical Trials Contact

clinical-trials-contact@bayer.com (+)1-888-84 22937 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.