Maternal Cancer Diagnosis and Treatment During Pregnancy:a Database for Maternal, Fetal, and Neonatal Outcomes

Age Range:Any
Start Date:July 2003
End Date:July 2023
Contact:Elyce H Cardonick, MD

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Maternal Cancer Diagnosis and Treatment During Pregnancy:a Registry for Maternal, Fetal, and Neonatal Outcomes With Longitudinal Follow up of Child Development and Maternal Psychological Well Being

The objective of this study is to follow the treatment options offered to pregnant women
diagnosed with cancer and study the impact that their treatment or delay of treatment has on
their own health and that of their children.

Approximately 1:1000 pregnancies are complicated by cancer. Breast cancer is the most common
type diagnosed during pregnancy. Termination of pregnancy has not demonstrated an improvement
in survival. Results of an international collaborative study reported similar overall
survival for patients diagnosed with breast cancer in pregnancy compared to nonpregnant
patients. The consensus medical opinion supports the option to start treatment with
continuation of the pregnancy. The purpose of this Cancer and Pregnancy Registry study is to
prospectively follow the women diagnosed with cancer during pregnancy-collecting information
about the method of diagnosis, treatment options and maternal and neonatal outcomes at
delivery and yearly at follow up.

The majority of fetal organogenesis is completed by 12 weeks of pregnancy, consistent with
the literature showing no increased malformation rate for chemotherapy use after the first
trimester of pregnancy. The central nervous system continues to develop throughout gestation
and after birth. Whether chemotherapy given after the first trimester affects central nervous
system maturity and results in developmental delays requires further study. The first authors
to provide detailed follow up on children exposed to chemotherapy in utero were Aviles and
Niz in 1988. At that time 17 children ranging in age from 4-22 years born to mothers with
acute leukemia who received chemotherapy during pregnancy were examined for physical health,
growth and development. Each child demonstrated normal growth and development, school
performance, intelligence testing, neurological examination, and hematologic evaluation
including bone marrow biopsies. This study was expanded twice. First in 1991, to 43 children
ranging in age from 3 to 19 years, also after exposure in utero to chemotherapy for maternal
hematologic malignancies. All children were normal physically and neurologically. School
performances and standardized intelligence testing were not significantly different from
controls (unrelated matched children and unexposed siblings). The same authors expanded their
study again to a final report of 84 children in 2001, confirming their previous reports that
chemotherapy at full doses for an aggressive hematological malignancy can be safely
administered. Standardized testing on children exposed to chemotherapy was not repeated for
11 years. Drs. Amant, et al reported developmental outcomes of 70 children in Europe exposed
to cancer treatment in utero. The children with developmental delays were concentrated in the
group delivered preterm. In this study there was not a control group of unexposed children.

Cardonick also performed developmental testing on 57 children of women diagnosed with cancer
during pregnancy. Ninety-five percent of children scored within normal limits on cognitive
assessments; 71% and 79% of children demonstrated at or above age equivalency in mathematics
and reading scores respectively.

Tooth formation of the primary teeth begins at 11 to 14 weeks of fetal life and is completed
postnatally. The enamel of the primary teeth begins to develop at 10 weeks and gradually
continues to develop throughout pregnancy; enamel development on the permanent teeth starts
in week 28 and begins to mineralize at the time of birth. It is known that both tetracycline
and antiepileptic medications use during pregnancy can affect tooth development. For example,
prenatal exposure tetracycline induces discoloration of deciduous teeth, while exposure to
antiepileptic drugs increases the risk of enamel opacities and hypoplasia. Enamel hypoplasia
increases susceptibility for primary dental caries due to an increased risk for bacterial
colonization. Peretz et al in 2003 reported the dental examination of 2 children exposed to
Doxorubicin+/-Cyclophosphamide during the third trimester for breast cancer. Both children at
18 and 30 months of age had normal primary teeth. Three women in the Cancer and Pregnancy
Registry have reported dental issues in their young children including under developed
primary teeth and early childhood caries. The effect of in utero exposure to chemotherapy on
amelogenesis requires further study.

Women diagnosed with cancer of any type during pregnancy can enroll voluntarily in the Cancer
and Pregnancy Registry. Signed medical release forms allow the investigator to review cancer
diagnostic studies and treatment course. Records are requested yearly from the treating
pediatrician and dentist to follow the growth and development of the child. All information
is kept confidential. Oncologic follow up on the women is also requested yearly.

Inclusion Criteria:

- Any pregnant woman diagnosed with cancer within 6 weeks before her last menstrual
period or 6 months after her end of pregnancy either by delivery or miscarriage.

Exclusion Criteria:

- Women diagnosed with cancer more than 6 months after the end of a pregnancy.
We found this trial at
1 Cooper Plaza
Camden, New Jersey 08103
(856) 342-2000
Phone: 856-342-2065
Cooper University Hospital Cooper University Health Care, the clinical campus of Cooper Medical School of...
Camden, NJ
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