Ulipristal acetate and pregnancy outcome-an observational study.

摘要: Study question Is the failure of selective progesterone receptor modulator 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 birth defects, spontaneous abortion (SAB) elective termination (ETOP)? Summary answer We did not find an increased SABs ETOPs after UPA during implantation and early embryogenesis. What is known already Pregnancy outcome data to are very limited. In cases EC unplanned treatment, women need well-grounded assessment minimize anxiety prevent unjustified pregnancy. design, size, duration Observational study prospectively ascertained pregnancies from German Embryotox institute (EC, n = 95; myoma, 7). Four retrospectively reported outcomes were evaluated separately. Participants/materials, setting, methods A total 226 requests on directed period 2010-2018. Outcomes exposed-(i) precycle, (ii) preconceptional (iii) first trimester-were using standardized questionnaires. Descriptive statistics applied. Main results role chance Failed resulted 95 pregnancies, which 56 had completed follow-up: 37 live births, 7 12 ETOPs. There was no major defect. Just 34% taken fertile window. Seven enrolled treated outcomes: five healthy births two SABs. Among four EC, there one child diagnosed Beckwith-Wiedemann syndrome (BWS). Limitations, reasons caution Our limited sample size does allow concluding safety use Wider implications findings provide preliminary basis reassuring who wish carry their term UPA. However, because report BWS exposure, possible epigenetic effect could be excluded requires further evaluation. funding/competing interest(s) This work performed financial support Federal Institute Drugs Medical Devices (BfArM). All authors declare that they have conflicts interest. Trial registration number Registered Clinical Register (DRKS00015155).