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Ethisterone during pregnancy:

Fetal Risk SummaryThe FDA mandated deletion of pregnancy-related indications for all progestins because of a possible association with congenital anomalies. No reports linking the use of ethisterone alone with congenital defects have been located. The Collaborative Perinatal Project monitored 866 mother-child pairs with 1st trimester exposure to progestational agents (including 2 with exposure to ethisterone) (1, pp. 389, 391). An increase in the expected frequency of cardiovascular defects and hypospadias was observed for the progestational agents as a group, but not for ethisterone as a single agent (1, p. 394). In a subsequent report from the Collaborative Study, a single case of tricuspid atresia and ventricular septal defect was identified with 3rd trimester exposure to ethisterone and ethinyl estradiol (2). Reevaluation of these data in terms of timing of exposure, vaginal bleeding in early pregnancy, and previous maternal obstetric history, however, failed to support an association between female sex hormones and cardiac malformations (3). An earlier study also failed to find any relationship with nongenital malformations (4). (See also Hydroxyprogesterone and Medroxyprogesterone)

Ethinyl Estradiol:

Fetal Risk SummaryEthinyl estradiol is used frequently in combination with progestins for oral contraception (see Oral Contraceptives). The Collaborative Perinatal Project monitored 89 mother-child pairs who were exposed to ethinyl estradiol during the 1st trimester (1, pp. 389, 391). An increased risk for malformations was found, although identification of the malformations was not provided. Estrogenic agents as a group were monitored in 614 mother-child pairs. An increase in the expected frequency of cardiovascular defects, eye and ear anomalies, and Down's syndrome was reported (1, p. 395).

Reevaluation of these data in terms of timing of exposure, vaginal bleeding in early pregnancy, and previous maternal obstetric history, however, failed to support an association between estrogens and cardiac malformations (2). An earlier study also failed to find any relationship with nongenital malformations (3). In a smaller study, 12 mothers were exposed to ethinyl estradiol during the 1st trimester (4). No fetal abnormalities were observed. Ethinyl estradiol has also been used as a contraceptive when given within 72 hours of unprotected midcycle coitus (5). Use of estrogenic hormones during pregnancy is contraindicated.

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