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Effects of Oncological Treatment During Pregnancy on Mother and Child

This study investigates how cancer and its treatments affect both mothers during pregnancy and their babies. Researchers want to understand if mothers who have cancer when pregnant, or receive treatment, have good health outcomes. They also aim to check if babies who were exposed to cancer or treatments like chemotherapy or radiotherapy while in the womb grow up to be healthy, especially looking at their brain and heart development. The study involves collecting samples from mothers and babies, using questionnaires for parents, and then regularly checking on the children's health, sometimes for many years.

At a glance

Status
Recruiting
Sponsor
University Hospital, Gasthuisberg
Enrolment target
5,000
Start
01 Aug 2005
Estimated completion
01 Dec 2032

What is this study about?

This important study wants to understand more about what happens when a mother has cancer during pregnancy. Since treating cancer often involves strong medicines or radiation, medical teams want to know how this affects both the mother's health and the baby's development. Currently, we need more information to give the best advice in these complex situations.

The main goals are to track the health of mothers who were diagnosed with cancer or received cancer treatment while pregnant. At the same time, the researchers will carefully check on their children. They will be looking to see if these children develop normally, paying special attention to how their brain and heart mature over time. This research aims to provide reassuring information for future parents and medical staff.

To do this, the study is split into two main parts. One part focuses on the mother's health, pregnancy, and delivery, collecting samples like blood and placenta. It also looks at how parents cope emotionally. The other part is a long-term follow-up for children, with regular health check-ups and questionnaires from infancy right through to adulthood, sometimes even including brain scans.

Key takeaways

  • The study looks at mums diagnosed with cancer during pregnancy and their children.
  • It checks how cancer treatments might affect a baby's development, especially their brain and heart.
  • Mothers' health and emotional wellbeing are also part of the study.
  • Children will have health check-ups from babyhood into adulthood.
  • Your participation helps improve care for future families.

Who may be eligible?

This study has two main parts, and you don't have to take part in both, but it's preferred if you can.

For the first part, which focuses on the mother and pregnancy, you must be a woman over 18 who has been diagnosed with cancer during pregnancy or within five years after giving birth. You must also be able to understand and sign the consent forms. If you've had certain cancer treatments like chemotherapy or radiotherapy during pregnancy, you can also join this part.

For the second part, which follows up on the children, it's for children who were exposed to cancer or cancer treatment while in the womb. Their parents will need to give permission. Once children turn 12, they'll also be asked to agree to take part. After they turn 18, they will give their own consent. The study cannot include people who have significant mental difficulties that would prevent them from understanding what's involved.

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.

  1. Are you a woman over 18?
  2. Were you diagnosed with cancer during pregnancy or up to 5 years after giving birth?
  3. Did your child receive cancer treatment exposure while in the womb?
  4. Can you understand and give informed consent?
  5. Are you willing for your child to have regular check-ups?
Answer every question to see your result.

What does participation involve?

If you decide to take part in the mother's part of the study, you might be asked to provide a blood sample during or shortly after birth, as well as samples from your baby's umbilical cord and placenta. You'll also complete questionnaires about your feelings and emotional needs related to your cancer diagnosis during pregnancy.

If your child takes part in the follow-up study, they will have regular health check-ups. These happen at 6 months, 18 months, and then at ages 3, 6, 9, 12, 15, and 18 years. After they turn 18, there will be heart checks and questionnaires every five years until they are 43. Some older children might also have MRI brain scans at certain ages. These check-ups will be done by specialist doctors and psychologists.

Potential risks and benefits

Taking part in this study could help us learn vital information to improve care for future mothers and babies. While there are no direct health benefits for you or your child, understanding these outcomes is a significant societal benefit. The risks are very low; they mainly involve the time taken for appointments and the minor discomfort of blood draws. Please remember you are free to stop participating at any time without giving a reason, and this will not affect your medical care.

Locations (33)

  • Cooper University Hospital (2015-ongoing)
    Verified postcode
    Camden, United States· Recruiting
  • Instituto Alexander Fleming
    Verified postcode
    Buenos Aires, Argentina· Withdrawn
  • Universitätsklinik für Frauenheilkunde und Geburtshilfe (retrospective 2016-2018)
    Verified postcode
    Graz, Austria· Terminated
  • UCL Brussels (2013-ongoing)
    Verified postcode
    Brussels, Belgium· Recruiting
  • UZ Gasthuisberg, Katholieke Universiteit Leuven (2004-ongoing)
    Verified postcode
    Leuven, Belgium· Recruiting
  • University Hospital Ostrava (2018-ongoing)
    Verified postcode
    Ostrava, Czechia· Recruiting
  • 3rd medical faculty of Charles University (2010-ongoing)
    Verified postcode
    Prague, Czechia· Recruiting
  • Copenhagen University Hospital (2015-ongoing)
    Verified postcode
    Copenhagen, Denmark· Recruiting
  • Hopital Bichat-Claude-Bernard (retrospective until 2018)
    Verified postcode
    Paris, France· Terminated
  • Universitätsklinik Freiburg (retrospective until 2018)
    Verified postcode
    Freiburg im Breisgau, Germany· Terminated
  • Euroclinic Hospital (2016-ongoing)
    Verified postcode
    Athens, Greece· Recruiting
  • Hellenic Anticancer-Oncological Hospital of Athens (retrospective 2015-2018)
    Verified postcode
    Athens, Greece· Terminated

Common questions

Why is this study important?

It's important because it helps doctors understand how cancer and its treatments during pregnancy affect mums and babies in the long run, leading to better care in the future.

Will taking part benefit me or my child directly?

While there are no direct health benefits, your participation will provide valuable knowledge that can help other families facing similar situations.

What kind of checks will my child have?

Children will have regular checks of their overall development, focusing on their brain and heart health, by specialist doctors and psychologists.

Can I leave the study at any time?

Yes, you can withdraw yourself or your child from the study at any point without it affecting your usual medical care.

Will my information be kept private?

Yes, all your personal and medical information will be kept confidential and handled securely.

How to find out more

Ayaka Wakatsuki

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

Interested in taking part?

Register your interest

Share your details and the research team for "Effects of Oncological Treatment During Pregnancy on Mother …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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