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

BJOG. 2007 Jun;114(6):769, e1-12. doi: 10.1111/j.1471-0528.2007.01339.x.

Abstract

Objective: To compare the impact of 1000-microgram self-administered vaginal misoprostol versus self-administered vaginal placebo at home on preoperative cervical ripening in both premenopausal and postmenopausal women prior to outpatient resectoscopy.

Design: Randomised, double-blind, placebo-controlled sequential trial.

Setting: Norwegian university teaching hospital.

Sample: Premenopausal and postmenopausal women referred to outpatient resectoscopy.

Methods: The women were randomised to either 1000 micrograms of self-administered vaginal misoprostol or self-administered vaginal placebo the evening before outpatient resectoscopy.

Main outcome measures: Preoperative cervical dilatation, acceptability and complications.

Results: (a) Intraoperative findings and distribution of cervical dilatation in the two treatment groups. Values are given as median (range) or n (%). (b) Acceptability in the two treatment groups. Values are given as completely acceptable, n (%); fairly acceptable, n (%); fairly unacceptable, n (%) and completely unacceptable, n (%). (c) Pain in the two treatment groups. Pain was measured with a visual analogue scale score, scale ranges from 0 (no pain) to 10 (unbearable pain). Values are given as median (range). (d) Occurrence of adverse effects in the two treatment groups. Values are given as n (%). (e) Complications, given as n (%).

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Intravaginal
  • Administration, Oral
  • Adult
  • Ambulatory Care
  • Cervical Ripening / drug effects*
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Female
  • Humans
  • Hysteroscopy / methods*
  • Misoprostol / administration & dosage*
  • Oxytocics / administration & dosage*
  • Patient Satisfaction
  • Postmenopause
  • Postoperative Complications / prevention & control*
  • Pregnancy
  • Premenopause
  • Preoperative Care / methods
  • Self Administration
  • Treatment Outcome
  • Uterine Diseases / surgery*

Substances

  • Oxytocics
  • Misoprostol

Associated data

  • ISRCTN/ISRCTN00120128