[Use of a new vaginal suppository: prostaglandin E1 analog Gemeprost for cervix maturation prior to abortion in the 1st trimester].

This double-blind study is concerned with the efficacy and safety of a new prostaglandin E1-analogue (16,16'-dimethyl-trans-delta 2PGE1-methylester) (Gemeprost) (ONO-802), which was administered as a single 1 mg vaginal pessary three hours prior to legal abortion. The efficacy of the prostaglandin was assessed by the largest size of the dilator meeting no resistance when inserted in the cervical channel. Furthermore, the quality of the cervix and the effort needed for further dilatation was evaluated. The average size of the cervix prior to dilatation was found to be 10 mm, in comparison to only 7 mm in the placebo-group (p less than 0.001). 80% of the patients of the Gemeprost group did not need any further dilatation, i.e. the dilatation procedure of the cervix was easier than in the group without treatment (19%). The incidence of uterine pain was more frequent in the Gemeprost group (40%) than in the Placebo group (7%). Analgesics were not required. The frequency of gastrointestinal side effects was rare in the Gemeprost group (13%) and in the Placebo group (11%) compared with other prostaglandins. By the preoperative application of a new prostaglandin E1-analogue (1 mg) prior to vacuum aspiration in the first trimenon of pregnancy sufficient softening of the cervix and a dilatation of the cervix was achieved. It significantly reduces the need for further mechanical dilatation of the cervix as well as the force needed to perform this dilatation. These effects reduce the trauma associated with mechanical dilatation and therefore diminish the risk of subsequent complications.

RCT Entities:   Population Interventions Outcomes