Cervical Ripening
Conditions
Keywords
Hysteroscopy, Misoprostol, Postmenopausal women, Cervical ripening, Dilatation, Sequential trial, Estradiol
Brief summary
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.
Interventions
DRUGMisoprostol
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.
DRUGPlacebo
Vaginal lactosum monohydricum administered 24 hours in postmenopausal women, compared to misoprostol after two weeks pretreatment with 25 micrograms daily vaginal oestradiol.
Sponsors
Helse Nord
Ullevaal University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the preoperative baseline cervical dilatation in the two treatment groups. | 24 hours |
Secondary
| Measure | Time frame |
|---|---|
| Difference between baseline cervical dilatation at recruitment and preoperative dilatation. | 14 days |
| Women with cervical dilatation ≥ 5 mm. | 14 days |
| Acceptability. | 14 days |
| Number of dilatations judged as difficult. | 14 days |
| Frequency of complications. | 14 days |
Countries
Norway
Outcome results
None listed