Abstract

In the present multicentre study 358 early pregnant women, up to 56 days following the onset of the last menstruation, were treated with vaginal suppositories containing 1.0 mg 16, 16-dimethyl-trans-Δ2-PGE1 methyl ester. Each patient received one suppository every three hours for a total of five suppositories. The outcome of the therapy, complete abortion, incomplete abortion, or continuation of pregnancy was evaluated two weeks after therapy. This judgement was based on clinical course, pregnancy test, gynecological examination, and, if curettage was regarded necessary, on the hitopathological examination. The frequency of complete abortion was 86.1% but the figure varied in the different centres from 74.2 to 100%. In the five centres that had the highest complete abortion rate the figures for complete abortion, incomplete abortion, and failure of treatment were 93%, 4.3%, and 2.2%. The frequency of gastrointestinal side effects was much lower than that reported previously for vaginal administration of 15-methyl-PGF2α methyl ester. The frequency of complications was low, signs of pelvic infection occurred in 2.5% of the patients. No patients experienced heavy bleeding during treatment, but one patient was transfused due to low hemoglobin value two weeks following treatment. It may be concluded that vaginal administration of 16, 16-dimethyl-trans-Δ2-PGE1 methyl ester in this study was not as effective as that reported for vacuum aspiration in terminating early pregnancy, except for the five centres in which the success appeared to be the same as for the surgical procedure. The risk for complication is comparable to that of the surgical procedure and the frequency of gastrointestinal side effects lower than vaginal administration of F analogues. The reason for the intercentre variation in efficacy needs to be clarified before extended use is recommended.

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