Prospective Study of Suspected Associations between Certain Drugs Administered during Early Pregnancy and Congenital Malformations

Abstract

From 1964 to 1976, a cohort study was performed in West Germany to study the possible influence of various factors on pregnancy and child development. Results of the evaluation of 13,643 pregnancies are given with respect to possible teratogenetic effects of antiemetic drugs and sex hormones administered in early pregnancy. There was no evidence of an increased risk of major malformations following the intake of certain antiemetic drugs and progesterone. Also, the use of a hormonal pregnancy test was not significantly associated with an increase of major malformations.

Population‐based case‐control teratogenic study of hydroxyprogesterone treatment during pregnancy

“…Finally, the possible association between the use of female sex hormones including progestins and cardiovascular CAs and limb deficiencies was described (Dillon 1970(Dillon , 1976Heinonen et al 1977a,b;Czeizel et al 1983, Wiseman & Dodds-Smith 1984. However, these findings as we mentioned previously were not confirmed (Michaelis et al 1983;Katz et al 1985;Resseguie et al 1985). In addition, Serment and Ruf (1968) found only two cases of clitoral hypertrophy in the offspring of more than 1500 pregnant women given hydroxyprogesterone.…”

“…This possible association was not confirmed later. Michaelis et al (1983) prospectively studied 648 patients given hydroxyprogesterone and found no increase in major CAs. In the study of Katz et al (1985), 1608 newborns were delivered from mothers who were treated with either oral medroxyprogesterone, or parenteral hydroxyprogesterone or their combination due to vaginal bleeding during the first trimester of pregnancy.…”

Drugs in infertility and fetal safety

“…More importantly, a collaborative study from West Germany, which included 186 progesteroneexposed pregnancies, could not find an increase in birth defects with progesterone (55). Three clinical studies support their findings (56)(57)(58).…”

“…Nevertheless, at least three studies demonstrated that estradiol use during pregnancy does not increase the risk of congenital anomalies (55,67,68). In addition, two metaanalyses could not find any association between firsttrimester exposure to oral contraceptives and malformations including external genital defects (69,70).…”

EUROmediCAT signal detection: an evaluation of selected congenital anomaly‐medication associations

“…Complete absence of a limb A Pregnen (4) derivatives are progestogens, compounds with biological activity similar to progesterone, used in hormone replacement therapy, infertility and to treat menstrual problems. Cohort and case-control studies found no significant increase in all CAs combined with any of the pregnen (4) derivatives [118][119][120][121][122][123][124]. A cohort study found that medroxyprogesterone (G03DA02) increases the rate of CHDs, gastro-intestinal defects, CAs of the integument, chromosome defects and all other defects.…”