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An ectopic pregnancy is a serious threat to women of reproductive age. Methotrexate therapy offers women with an ectopic pregnancy an alternative to surgical management. The safety of this treatment is an important issue. To assess the safety of methotrexate when withdrawn at the time of normalisation of serum human chorionic gonadotropin levels in women with an ectopic pregnancy. We carried out a prospective study of 125 women with an ectopic pregnancy in two hospitals in the UK. All patients received intramuscular methotrexate in doses of 50 mg/m(2) when pregnant for seronegative ectopic pregnancy and 37.5 mg/m(2) for seropositive ectopic pregnancy. The patients were followed-up weekly and pregnancy outcome data was collected. The mean baseline serum human chorionic gonadotropin level in patients with an ectopic pregnancy was 194 (95% confidence interval 183-203) IU/l, with a mean of 223 IU/l on the day of treatment with methotrexate. Ectopic pregnancy resolved in 95% of women at a median of 10 days (95% confidence interval 3-16) after the methotrexate treatment. There was a highly significant correlation between declining human chorionic gonadotropin level and the days of therapy. After the treatment, 11 women were still pregnant with pregnancy outcome data available for 8 of these. The pregnancy outcome data available for the 8 patients showed that a complete spontaneous abortion occurred in one woman. Another patient had an intrauterine pregnancy that was delivered at 39 weeks gestation, a third patient had a vaginal pregnancy that was terminated at 12 weeks gestation, and the outcome was unknown in the remaining four women. Oral and rectal bleeding as side effects were reported in 9 of 125 women (7%) at the first assessment. No patients reported symptoms of methotrexate toxicity at the time of treatment. Oral and rectal bleeding were the most commonly reported side effects. The mean side effect burden score was 1.05 (95% confidence interval 0.70-1.40) at the first assessment. No patient required surgical intervention for side effects. After methotrexate was stopped, no patient required
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