Randomised trial of high doses of stilboestrol and ethisterone therapy in pregnancy: long-term follow-up of the children

Abstract

The 27-year follow-up is reported of 136 children whose mothers were involved in a randomised trial of high doses of stilboestrol and ethisterone therapy during pregnancy. The children were not contacted directly. Information about them was obtained from hospitals, general practitioners, and other official sources; and the persons who responded to our inquiries were unaware of who had been exposed to hormones in utero and whose mothers had received an inactive tablet. All children were traced. Urogenital anomalies were reported more frequently in the hormone-exposed than the unexposed children (14% and 9% respectively). The earlier in pregnancy the therapy began, the higher the prevalence rate of abnormalities (X2 for trend, p less than 0.02). No malignant tumours were reported. For males, the proportion reported to be married or living as married was lower in the exposed than in the unexposed group (32% and 62% respectively). The proportion was lower the earlier in pregnancy hormonal exposure occurred and the higher the total hormone dose to which they were exposed (X2 for trend, p less than 0.02). These findings suggest that some interference with sexual function may not be uncommon in males exposed to high doses of stilboestrol and ethisterone while in utero.