P-524 Fertility and subsequent pregnancy outcomes among women with tubal ectopic pregnancy treated with methotrexate

Abstract

Abstract Study question What are the future fertility prospects and subsequent pregnancy outcomes among women with tubal ectopic pregnancy treated with methotrexate? Summary answer Pregnancy post-ectopic pregnancy occurred in 53% of women within 12 months following methotrexate treatment. Among those who became pregnant, ectopic pregnancy recurrence occurred in 16.8%. What is known already Concerns regarding ectopic pregnancy recurrence and future fertility predominate when counselling women about management options for tubal ectopic pregnancy treatment. Current UK National Institute for Health and Care Excellence guidance is based on low quality evidence and estimate long-term ectopic pregnancy recurrence rate of ∼18.5%. Further, they state that there are no differences in rates of subsequent pregnancy or ectopic pregnancy recurrence between ectopic pregnancy management methods. However, 30% of women managed with methotrexate experience treatment failure and require rescue surgery and subsequent pregnancy outcomes in this group are poorly understood. Study design, size, duration The data for this study were derived from a UK multicentre RCT of methotrexate and gefitinib versus methotrexate and placebo for treatment of ultrasound diagnosed definite or probable tubal ectopic pregnancy with pre-treatment hCG ≥1000 IU/L and ≤5000 IU/L (GEM3). The trial found adding gefitinib to methotrexate was not superior to placebo. This analysis reports trial participant follow-up data at 12-months examining post-treatment fertility, subsequent pregnancy outcomes and participant characteristics associated with ectopic pregnancy recurrence. Participants/materials, setting, methods Trial participants of GEM3 (as described above). Participants were contacted to provide follow-up data 12 months after randomisation to treatment. Where telephone contact was unsuccessful, electronic health records were reviewed to collect pregnancy outcome data. Post-treatment fertility and pregnancy outcomes were summarised using descriptive statistics and compared between groups using a chi-squared test, p<.05 signified statistical significance. Main results and the role of chance Pregnancy follow-up data was obtained for 283/327 trial participants. (167 participants were successfully contacted by telephone; the electronic health records were reviewed for 116 participants). 52.7% (149/283) of the trial participants became pregnant in the 12-month follow-up period. There was no difference in subsequent pregnancy rates between ‘methotrexate only’ and ‘methotrexate and rescue surgery’ groups. The surgical approach (salpingectomy vs salpingotomy) did not affect subsequent pregnancy rates. Among women who had a pregnancy in the follow-up period, a live birth was recorded in 65% of women (n = 93/142, n = 7 missing), any pregnancy loss (miscarriage, ectopic pregnancy, stillbirth, termination of pregnancy or molar pregnancy) was recorded in 43% of women (n = 59/137, n = 12 missing). Recurrent ectopic pregnancy was reported in 16.8% of women (n = 22/131, n = 18 missing). There was no difference in rates of live birth, pregnancy loss or recurrent ectopic pregnancy between methotrexate only and methotrexate and surgery groups or between type of surgical management groups (salpingectomy vs salpingotomy). Limitations, reasons for caution This study only reports on a 12-month follow-up period and this should be considered when interpreting comparatively low post-treatment pregnancy rates. We did not record which couples were trying-to-conceive post treatment and were therefore unable to stratify results by this variable or report subfertility rates. Wider implications of the findings This prospective dataset strengthens current understanding of the likelihood of ectopic pregnancy recurrence. Furthermore, it provides reassurance that women with tubal ectopic pregnancy managed with methotrexate requiring rescue surgery have similar post-treatment fertility and pregnancy outcomes to those successfully treated with methotrexate. Trial registration number ISRCTN67795930