Cervical dilatation with 16,16-dimethyl-trans-delta 2-PGE1 methyl ester (Cervagem) prior to vacuum aspiration. A double-blind, placebo-controlled randomized study.
In the article are presented the results of a randomized double-blind study comparing the efficacy and tolerance of vaginal administration of 1.0 mg 16,16-dimethyl-trans-delta 2-PGE1 methyl ester and placebo as a pretreatment to vacuum aspiration for termination of pregnancy in nulliparae in the 8th to 12th weeks of gestation. One-hundred and-twenty-six patients fulfilled all the criteria for acceptance in the study and received either 1 mg of the E analogue or placebo three hours prior to vacuum aspiration. The mean cervical dilation at operation was following treatment with the E analogue 6.5 mm and with placebo 4.9 mm (p less than 0.001). The number of patients requiring no further mechanical dilation or the dilatation was considered easy was significantly higher in the prostaglandin-treated group than in the placebo group (p less than 0.001). The mean blood loss at operation was also higher in the placebo group (p less than 0.001). Uterine pain was slightly more common following prostaglandin treatment (p less than 0.05) while gastrointestinal side effects occurred equally often in both groups. In two patients the uterine wall was perforated, both perforations occurring in the placebo group. Late complication rates were comparable between the two groups. It can be concluded that pretreatment with the E analogue accomplishes sufficient dilatation and softening of the cervix in most patients. The efficacy of the procedure and its low frequency of side effects and complications make the procedure useful for cervical dilatation prior to vacuum aspiration in late first trimester pregnancy.
D000019:Abortifacient Agents / Q000009:adverse effects; D000020:Abortifacient Agents, Nonsteroidal / Q000009:adverse effects; D000028:Abortion, Induced / Q000379:methods*; D000293:Adolescent; D000328:Adult; D000527:Alprostadil / Q000031:analogs & derivatives*; D002584:Cervix Uteri / Q000187:drug effects; D002986:Clinical Trials as Topic; D004107:Dilatation and Curettage; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D011247:Pregnancy; D011292:Premedication; D011459:Prostaglandins E, Synthetic / Q000009:adverse effects; D014619:Vacuum Curettage
D000019:Abortifacient Agents; D000020:Abortifacient Agents, Nonsteroidal; D011459:Prostaglandins E, Synthetic; C021182:gemeprost; D000527:Alprostadil