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

Abstract

Hydroxyprogesterone, a synthetic progestin, was used for the treatment of pregnant women with threatened abortion and preterm delivery. Previous studies showed some association between hydroxyprogesterone use during early pregnancy and some specific congenital abnormalities. The population-based large Hungarian data set seemed to be appropriate to check this possible association. The Hungarian Case-Control Surveillance of Congenital Abnormalities between 1980 and 1996 includes 22 843 cases with congenital abnormalities and 38 151 controls without any defect. 318 (1.4%) cases, while 433 (1.1%) controls had mothers with hydroxyprogesterone treatment during pregnancy (adjusted POR with 95% CI: 1.3, 1.1-1.5). However, there was no association between risk for any congenital abnormality group and a higher use of maternal hydroxyprogesterone treatment during the second and third month of gestation. On the other hand hydroxyprogesterone is not effective in the prevention of preterm delivery. In conclusion, there was no detectable risk for congenital abnormalities in the offspring of mothers with hydroxyprogesterone treatment during early pregnancy, however, there is no reasonable indication of this treatment during pregnancy.

Maternal risk factors in the origin of isolated hypospadias: A population‐based case‐control study

“…The use of hydroxyprogesterone during pregnancy in the mothers of cases with CA and their matched controls did not show significant association with the risk of IHS (OR with 95% CI: 1.2, 0.6-2.3) in a previous study (Dudás et al 2006) and this finding was confirmed in this study.…”

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

“…These findings may be due to chance as multiple comparisons were made and the range of defects including chromosomal defects is not plausible [125]. A number of case-control studies have found a significant association between hypospadias and both hydroxyprogesterone (G03DA03) and progesterone (G03DA04) [46,126,127]. However, other studies have found no association [44,47,128] and recall bias is a concern [48].…”

Progesterone for maintenance tocolytic therapy after threatened preterm labour: A randomised controlled trial

“…Especially for progestins with an androgenic effect, there was fear for masculinisation of the female fetus. Research among exposed women and controls showed no difference with respect to the occurrence of abnormalities of the central nerve system, limbs and joints, urogenital tract and circulatory tract between treated and untreated pregnancies, even when 17OHPC was administered in early pregnancy 8,9 . The effectiveness of 17P in reducing preterm delivery (PTD) in at‐risk pregnancies was first demonstrated in the 1970s 10,11 .…”