A randomized double blind study of a new ready-for use prostaglandin gel (Org 2436) for cervical ripening prior to first trimester pregnancy termination.
In a placebo-controlled double-blind randomized study involving 50 primigravidae scheduled for termination of first trimester pregnancy 500 micrograms PGE2 gel or placebo gel were applied intracervically 6 hours before curettage. The priming effect was verified in all patients by means of comparative examinations with a special tonometer before application of the gel and immediately before the surgical procedure. No abortion or vaginal bleeding occurred in any of the patients. After 500 micrograms PGE2 gel the mean free passability (i.e. force less than or equal to 1 Newton) was 7.8 (+/- 2.0) mm, the corresponding value for the placebo group 5.2 (+/- 1.2) mm (p less than 0.0001). The prostaglandin pretreatment led to a significant increase in dilation of 5.9 +/- 2.3 mm versus 2.0 +/- 1.2 mm in the placebo group (p less than 0.0001). 17 of the 25 PGE2-treated patients complained of lower abdominal pain, gastrointestinal side effects were observed in one of these patients. In the placebo group there were no undesired concomitant symptoms. No intra- or postoperative complications occurred in the PGE2 gel-treated group. After application of the placebo gel cervical lesions and incomplete curettages were demonstrated in 4 cases. According to this preliminary experience, the intracervical application of the new ready-for-use-PGE2 gel represents a practicable and efficient method for preoperative cervical priming. In view of the intraoperative complications in the placebo group the frequency of side effects after PG application are within tolerable limits.
Osmers
R
R
Department of Obstetrics and Gynecology, University Hospital, Göttingen, Federal Republic of Germany.
Rath
W
W
Conrad
A
A
Kuhn
W
W
D000028:Abortion, Induced / Q000379:methods*; D000282:Administration, Intravaginal; D000293:Adolescent; D000328:Adult; D002584:Cervix Uteri / Q000187:drug effects*; D015232:Dinoprostone / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D005782:Gels; D006801:Humans; D010147:Pain Measurement; D011247:Pregnancy; D011261:Pregnancy Trimester, First
D005782:Gels; D015232:Dinoprostone