Ulipristal acetate and pregnancy outcome – an observational study

Study question Is the failure of the selective progesterone receptor modulator (SPRM) ulipristal acetate (UPA) as emergency contraception (EC, 30 mg, single) or inadvertent exposure for myoma treatment (5 mg/d) in pregnancy associated with a higher risk of birth defects, spontaneous abortion (SAB) or elective terminations of pregnancy (ETOP). Pregnancy outcome data after exposure to UPA are very limited.

Materials Observational study of prospectively ascertained pregnancies with UPA exposure (EC n = 95; myoma n = 7). 4 retrospectively reported pregnancy outcomes were evaluated separately.

Methods 226 requests on UPA were directed to the German Embryotox institute during the study period 2010 to 2018.

Results Failed EC with UPA resulted in 95 prospectively ascertained pregnancies of which 56 had completed follow up: 37 live births, 7 SAB and 12 terminations of pregnancy (ETOP). There was no major birth defect. Just 34 % of women had taken UPA during the fertile window. 7 prospectively enrolled pregnancies were treated for myoma and had known pregnancy outcomes: 5 healthy live births and 2 SABs. Among the 4 retrospectively reported pregnancies after EC there was one child diagnosed with Beckwith-Wiedemann-syndrome (BWS).

Summary We did not find an increased risk for birth defects, SABs or ETOPs after UPA exposure during implantation and early embryogenesis. We provide a preliminary basis for reassuring women who wish to carry their pregnancy to term after EC or myoma treatment with UPA. However, because of the report of a BWS after UPA exposure a possible epigenetic effect could not be excluded and requires further evaluation.

Publication History

Article published online:
07 October 2020