Hysteroscopy After Pretreatment With Misoprostol and Estradiol Trial

Ullevaal University Hospital100 enrolled

Overview

The aim of this study is to investigate whether 1000 micrograms of self-administered vaginal misoprostol 12 hours before operative hysteroscopy results in effective preoperative cervical ripening after two weeks pretreatment with 25 micrograms daily vaginal estradiol, compared to placebo (lactosum monohydricum) in postmenopausal women.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

100

Conditions

Cervical Ripening

Interventions

MisoprostolDRUG

1000 micrograms of self-administered vaginal misoprostol compared to placebo 12 hours before operative hysteroscopy after two weeks pretreatment with 25 micrograms daily vaginal oestradiol.

PlaceboDRUG

Vaginal lactosum monohydricum administered 24 hours in postmenopausal women, compared to misoprostol after two weeks pretreatment with 25 micrograms daily vaginal oestradiol.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * All postmenopausal (\> one year since last menstruation) women who are referred to outpatient hysteroscopy with a medical indication for hysteroscopy, and who have given informed consent, will be eligible for study recruitment Exclusion Criteria: * Women who do not wish to participate * Women who are medically unfit for hysteroscopy * Women who are medically unfit for participation in any clinical trial * Women who do not have a medical indication for hysteroscopy * Women who have previously had, or currently have breast or gynaecological cancer * Women who have a medical contraindication for locally applied oestradiol * Women who are currently using hormone therapy * Women who are unable to communicate in Norwegian, and * Women with a known allergy to misoprostol

Locations (1)

Gynaecological Department, Ullevål University Hospital

Oslo, Norway

Outcomes

Primary Outcomes

The primary outcome is the preoperative baseline cervical dilatation in the two treatment groups.

Time frame: 24 hours

Secondary Outcomes

Difference between baseline cervical dilatation at recruitment and preoperative dilatation.

Time frame: 14 days

Women with cervical dilatation ≥ 5 mm.

Time frame: 14 days

Acceptability.

Time frame: 14 days

Number of dilatations judged as "difficult."

Time frame: 14 days

Frequency of complications.

Time frame: 14 days

Data from ClinicalTrials.gov

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