Christof Schaefer1, Reinhard Meister, René Wentzeck, Corinna Weber-Schoendorfer. 1. Pharmakovigilanz- und Beratungszentrum für Embryonaltoxikologie (BBGes), Berlin Institute for Clinical Teratology and Drug Risk Assessment in Pregnancy, Spandauer Damm 130, Haus 10, Berlin 14050, Germany. schaefer@embryotox.de
Abstract
OBJECTIVE: Occasionally, either for urgent diagnostic reasons or by accident, pregnant women are exposed to technetium scintigraphy, the consequences of which were unknown, due to lack of systematic data. Therefore, clinical data was needed to assess the risk and safety of technetium scintigraphy with respect to prenatal development. METHODOLOGY: Requests for information with regard to technetium scintigraphy from pregnant women or their physicians were followed by the Berlin Institute for Clinical Teratology. A prospective observational cohort study was performed using data collected between 1991 and 2008. Pregnancy outcome for a cohort of pregnant women exposed to Tc-99m-scintigraphy of thyroid (n=102) or bone (n=20) during pregnancy was compared with a control group without teratogenic exposure (n=366). RESULTS: Major birth defects were no more common in the study group than in the control group (OR 1.00; 95% CI 0.23-3.38) and no specific pattern of birth defects was found. Spontaneous abortion rate (OR 0.51), preterm deliveries, and birth measurements of newborns were not significantly different from controls. CONCLUSION: This prospective observational study suggests that the inadvertent exposure to Tc-99m-scintigraphy in early pregnancy is relatively safe for the fetus.
OBJECTIVE: Occasionally, either for urgent diagnostic reasons or by accident, pregnant women are exposed to technetium scintigraphy, the consequences of which were unknown, due to lack of systematic data. Therefore, clinical data was needed to assess the risk and safety of technetium scintigraphy with respect to prenatal development. METHODOLOGY: Requests for information with regard to technetium scintigraphy from pregnant women or their physicians were followed by the Berlin Institute for Clinical Teratology. A prospective observational cohort study was performed using data collected between 1991 and 2008. Pregnancy outcome for a cohort of pregnant women exposed to Tc-99m-scintigraphy of thyroid (n=102) or bone (n=20) during pregnancy was compared with a control group without teratogenic exposure (n=366). RESULTS: Major birth defects were no more common in the study group than in the control group (OR 1.00; 95% CI 0.23-3.38) and no specific pattern of birth defects was found. Spontaneous abortion rate (OR 0.51), preterm deliveries, and birth measurements of newborns were not significantly different from controls. CONCLUSION: This prospective observational study suggests that the inadvertent exposure to Tc-99m-scintigraphy in early pregnancy is relatively safe for the fetus.
Authors: Jonathan P Pearl; Raymond R Price; Allison E Tonkin; William S Richardson; Dimitrios Stefanidis Journal: Surg Endosc Date: 2017-06-22 Impact factor: 4.584