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

ABSTRACT:

Objective

To compare the impact of 1000 micrograms of self-administered vaginal misoprostol versus self-administered vaginal placebo at home on preoperative cervical ripening in both premenopausal and postmenopausal women before operative hysteroscopy.

Design

Two separate but identical parallel, randomised, double-blind, placebo-controlled sequential trials, one in premenopausal women and one in postmenopausal women. The boundaries for the sequential trials were calculated on the primary outcomes of a difference of cervical dilatation > or = 1 mm, with the assumption of a type 1 error of 0.05 and a power of 0.95.

Setting

Norwegian university teaching hospital.

Sample

Eighty-six women referred to outpatient operative hysteroscopy.

Methods

The women were r

SUBMITTER: Oppegaard KS 

PROVIDER: S-EPMC2345467 | biostudies-literature | 2008 Apr

REPOSITORIES: biostudies-literature