Donna M. Glebatis

Oral contraceptives and congenital limb-reduction defects.

Abstract Exposure to exogenous sex steroids during pregnancy was investigated for 108 mothers of patients with congenital limb-reduction defects and 108 mothers of normal controls. Exposure resulted from pregnancy tests, supportive hormone therapy, and breakthrough pregnancies occurring while the mother was using oral contraceptives. Among mothers with malformed children, 15 (14 per cent) had a history of exposure; four (4 per cent) control mothers of normal children were exposed. Of the 15 exposed and affected children, the mothers of 11 had received orally administered hormones. The sex ratio of the nonexposed children was not exceptional, but affected children with a history of exposure to orally administered hormones were all males. This association suggests that orally ingested progestins may have an effect on the developing fetus that is sex-specific. (N Engl J Med 291:697–700, 1974)

Breast cancer and oral contraceptive use: A case-control study☆

The effect of oral contraceptive (OC) use was examined among parous breast cancer cases diagnosed at less than or equal to 45 years of age, and in two different general population control groups of parous women. The primary analysis compared 278 cases with 520 controls. In the secondary analysis, a subgroup of 190 cases were compared with 190 controls from another reference group. In both analyses, ever use of OC, duration of OC use, and OC use prior to first pregnancy showed no significant association with breast cancer risk. Also in both analyses, in women with prior benign breast disease OC use increased the risk of breast cancer, although this finding was statistically significant only in the larger group used in the primary analysis.

A Statewide Approach to Diethylstilbestrol — The New York Program

In August 1978, the New York State Legislature passed a bill to develop a program that would deal with the health problems associated with exposure to diethylstilbestrol (DES). The law, enacted as ...

Case-control studies on the effect of sex steroids on women and their offspring

This paper discusses the case-control method for studies of birth defects and breast tumors as side effects of oral contraception (OC). The term case-control is used for any investigation which seeks to compare exposure frequencies between diseased and nondiseased groups. Case-control studies have 2 handicaps: 1) relative risk is expressed in terms of exposure among the diseased and 2) exposure is ascertained after the disease has occurred which can increase the possibility of obtaining biased exposure information. In order to eliminate the problem of bias each study must be designed to assure procedural excellence and absolute equality in the ascertainment of exposure in cases and controls. Careful evaluation of all sources of bias is an integral part of the case-control study procedure. Case-control studies are the strongest analytic epidemiological tools for the study of causal mechanisms of diseases; the most immediate problem investigators encounter is selection of the case and control population. The authors have applied their method of the case-control study to a study of 317 cases of breast cancer taken from the 1970-75 files at the New York State Cancer Registry. Age at diagnosis was classifed at less than 35 and at 35-44. To conduct this study the authors first conducted 2 separate case-control investigations to determine whether early pregnancy protects against breast cancer and whether the sex of the 1st child can be a risk of breast cancer in young women; they found that the male offspring has a uniformly greater effect of risk especially under 35 years of age. The same method was used in a case-control study of the association between OC and cardiac fetal malformations and results were compared to those of 2 similar studies that had been conducted with a different method. It was that the differences in relative risk between the 3 studies were likely to be due to methodological differences in the studies specifically the differences in case selection.