title: [Effect of the PGE1 methyl analog misoprostol on the pregnant uterus in the first trimester].
abstract: The effect of misoprostol, a PGE1 methyl analogue, on the pregnant human uterus was unknown at dosage levels normally used in the treatment of gastric and duodenal ulceration. Data from animal fertility and teratology studies suggested no activity at an anti-ulcer dosage level. In a double-blind placebo-controlled study, 300 patients (9.-12. week of gestation) were treated with two doses of misoprostol (study A: 2 X 400 micrograms; study B: 2 X 200 micrograms) or placebo during the evening before a legally permitted termination of first-trimester pregnancy. A partial or complete abortion occurred spontaneously in 11% of patients receiving misoprostol 2 X 400 micrograms, 9% of patients receiving misoprostol 2 X 200 micrograms and none of the patients receiving placebo. The incidence of vaginal bleedings (A: 45%, B: 34%), abdominal pain (A: 42%, B: 43%) and the softening of the cervix were all significantly increased by misoprostol treatment. These results show that the sensitivity of the human pregnant uterus to prostaglandin analogues cannot be reliably predicted from animal studies. Furthermore, misoprostol should not be used in human first-trimester pregnancy. The effect of misoprostol on second and third-trimester pregnancy (e.g. labour induction) is still unknown.
mesh_terms: D000019:Abortifacient Agents; D000028:Abortion, Induced; D000293:Adolescent; D000328:Adult; D000527:Alprostadil / Q000031:analogs & derivatives*; D002584:Cervix Uteri / Q000187:drug effects; D002986:Clinical Trials as Topic; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008875:Middle Aged; D016595:Misoprostol; D011247:Pregnancy; D011261:Pregnancy Trimester, First; D011897:Random Allocation; D014590:Uterine Contraction / Q000187:drug effects*
chemical_list: D000019:Abortifacient Agents; D016595:Misoprostol; D000527:Alprostadil
vernacular_title: Wirkung des PGE1-Methylanalogons Misoprostol auf den schwangeren Uterus im ersten Trimester.