Effects of Oncological Treatment During Pregnancy on Mother and Child

Launched by UNIVERSITY HOSPITAL, GASTHUISBERG · May 25, 2006

Keywords

ClinConnect Summary

This clinical trial is studying the effects of cancer treatment during pregnancy on both mothers and their children. Researchers want to understand how cancer and its treatments, like chemotherapy and radiation, impact the health of mothers and the development of their children. They are particularly interested in whether mothers who receive treatment during pregnancy have good overall health and whether their children grow and develop normally after birth, including their brain and heart health.

To participate, mothers must be over 18 years old and have been diagnosed with cancer while pregnant or within five years after giving birth. They need to agree to take part in the study and understand what it involves. For the second part of the study, children who were exposed to cancer or cancer treatment during pregnancy can also participate, with consent from their parents. This trial is currently recruiting participants, and it aims to provide important information that may help improve care for pregnant women with cancer and their children.

Gender

FEMALE

Eligibility criteria

• • Patients do not need to participate in both; however, preferentially both study parts should be performed.
• • \*\*\*\*\*\*\*\*\*\*\*\*\*\*Part I: Pregnancy, delivery and maternal health\*\*\*\*\*\*\*\*\*\*\*\*\*\*
• Patients must meet the following inclusion criteria:
• • Histologically proven cancer in association with a pregnancy (during pregnancy or cancer dagnosis within 5 years after pregnancy)
• • \> 18 years of age, premenopausal
• • Patients who have given their signed and written informed consent to participate in the trial after fully understanding the implication of the protocol
• • Women receiving any cytotoxic drug or radiation therapy during pregnancy are allowed for the assessment of the maternal and fetal outcome (Part II).
• Exclusion Criteria:
• • Mentally disabled or significantly altered mental status that would prohibit the understanding and giving of informed consent
• • \*\*\*\*\*\*\*\*\*\*\*\*\*\*Part II: Follow-up of children\*\*\*\*\*\*\*\*\*\*\*\*\*\*
• Inclusion Criteria:
• • - Children that were prenatally exposed to cancer of cancer treament. Informed Consent is asked from parents. From the age of 12 years, informed assent is additionally asked from the child. After the age of 18 years, informed consent is solely asked of the offspring.
• Exclusion Criteria:
• • Mentally disabled or significantly altered mental status that would prohibit the understanding and giving of informed consent