A randomised placebo‐controlled trial of vaginal misoprostol for cervical priming before hysteroscopy in postmenopausal women

Abstract

Objective To investigate the effectiveness of misoprostol given vaginally for cervical priming before hysteroscopy in postmenopausal women. Design Double-blind randomised controlled study.Setting Regional hospital, Hong Kong.Participants One hundred women with postmenopausal bleeding scheduled for hysteroscopy from October 1998 to September 2001 were randomly assigned to receive either misoprostol or placebo vaginally before the operation. Main outcome measures The number of women requiring cervical dilatation, outcome of hysteroscopy and side effects of the medication were assessed. Results Forty-eight women receiving misoprostol and 48 women receiving placebo were compared. The mean degree of endocervical diameter estimated by Hegar's dilator was similar between the treatment group and the control group. A similar number of women in the treatment group and the control group required cervical dilatation. The operative times for both groups were similar. The incidence of side effects was comparable in both groups. The most common side effects for misoprostol were febrile episodes and diarrhoea. There was no cervical tear nor uterine perforation encountered in both groups. The mean duration of hospital stay in both groups were similar. Subanalysis of results were similar in women receiving vaginal medication at least five hours before the operation. Conclusion Vaginal misoprostol was not shown to reduce the need for cervical dilatation in postmenopausal women. It cannot convert diagnostic hysteroscopy from a hospital procedure into an office one in postmenopausal women with tight cervical os.

Priming Effect of Misoprostol on Estrogen Pretreated Cervix in Postmenopausal Women

“…In many studies which have evaluated the effect of misoprostol on cervical ripening, undissolved misoprostol tablets in vagina were reported and this may be a factor for ineffectiveness of vaginal misoprostol treatment. Fung et al (2002) did not show a significant difference in the incidence of undissolved medication when the drug was administered overnight, and about 5 hours are necessary for drug absorption with the assumption that the active ingredient drug was released while the tablet remained in vagina. In order to eliminate this possibility of inappropriate absorption, we have used enteral route for the administration of misoprostol.…”

“…However, only a few studies had been reported on postmenopausal misoprostol use for cervical ripening and these studies had shown no beneficial effect (Ngai et al 2001;Fung et al 2002). Presence of beneficial effect of misoprostol only during premenopausal women questioned the possible effect of reproductive hormones on ameliorating activity of misoprostol on cervical ripening.…”

See and Treat Hysteroscopy in Evaluation and Management of Abnormal Uterine Bleeding: Our Experience at a Rural Teaching Hospital of Chhatisgarh

“…it amounts to 35% of gynae OPD visits and 25% of gynaecological surgeries and this incidence rises to 65% in peri and postmenopausal age (1) This condition has enormous consequences with regard to social life, morbidity and clinical workload (2)(3)(4) . Hysteroscopy as an outpatient procedure is an important method for diagnosis of AUB (5,6) . Although the major role of out-patient hysteroscopy in the management of AUB, is diagnostic, there is scope for simple operative procedures such as polypectomy, and targeted endometrial biopsy (6) .…”

Author response to: Comparison of self‐administered vaginal misoprostol versus placebo for cervical ripening prior to operative hysteroscopy using a sequential trial design

“…The majority do not find a significant ripening effect of misoprostol compared with placebo. [2][3][4] A couple of studies have suggested that misoprostol is effective: Barcaite et al 5 and Thomas et al 6 have concluded in their studies that misoprostol is effective for cervical ripening in postmenopausal women. However, their studies have methodological flaws.…”