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.
