Does self-administered vaginal misoprostol result in cervical ripening in postmenopausal women after 14 days of pre-treatment with estradiol? Trial protocol for a randomised, placebo-controlled sequential trial.

ABSTRACT:

Objective

To compare the impact of 1000 micrograms of self-administered vaginal misoprostol versus self-administered vaginal placebo on preoperative cervical ripening after pre-treatment with estradiol vaginal tablets at home in postmenopausal women prior to day-care operative hysteroscopy.

Design

Randomised double-blind placebo-controlled sequential trial. The boundaries for the sequential trial were calculated on the primary outcomes of a difference of cervical dilatation > or = 1 millimetre, with the assumption of a type 1 error of 0.05 and a power of 0.95.

Setting

Norwegian university teaching hospital.

Population

Postmenopausal women referred for day-care operative hysteroscopy.

Methods

The women were randomised to either 1000 micrograms of self-adm

SUBMITTER: Oppegaard KS 

PROVIDER: S-EPMC2440527 | biostudies-literature | 2008 Jun

REPOSITORIES: biostudies-literature