NCT00363389

Brief Summary

To investigate if self-inserted vaginal misoprostol prior to outpatient hysteroscopy will lead to satisfactory cervical ripening, compared to placebo.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2006

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 15, 2006

Completed
17 days until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

August 7, 2007

Status Verified

April 1, 2007

First QC Date

August 10, 2006

Last Update Submit

August 6, 2007

Conditions

Uterine Hemorrhage

Keywords

HysteroscopyMisoprostolUterine hemorrhageUterine cervixDilatation

Outcome Measures

Primary Outcomes (1)

  • The primary outcome: mean pre-operative baseline cervical dilatation 6.4 mm in misoprostol group and 4.8 mm in placebo group in premenopausal women. Misoprostol was not effective for cervical ripening in postmenopausal women, compared to placebo.

    24 hours

Secondary Outcomes (4)

  • The 60% of premenopausal women achieved satisfactory cervical priming (cervical dilatation ≥ 5 mm) preoperatively, compared to 40% in the placebo group.

    24 hours

  • 32 % of premenopausal women who received placebo were judged "difficult to dilate", compared to 12% of premenopausal women who received misoprostol. 42% of postmenopausal women were judged to be "difficult to dilate".

    24 hours

  • Frequency of complications: 11%.

    14 days

  • Acceptability of self-administration of vaginal capsules at home: 83% of premenopausal and 76% of postmenopausal found this to be an acceptable treatment.

    24 hours

Interventions

misoprostol and cervical ripeningDRUG

Eligibility Criteria

Age18 Years - 73 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients who are referred to outpatient hysteroscopy, and who have given informed consent, will be eligible for study recruitment.

You may not qualify if:

  • Women who are unable to communicate in Norwegian
  • Women with a known allergy to misoprostol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gynaecological Department, Ullevål University Hospital

Oslo, N-0407, Norway

Location

MeSH Terms

Conditions

Uterine HemorrhageDilatation, Pathologic

Interventions

MisoprostolCervical Ripening

Condition Hierarchy (Ancestors)

Uterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsPathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological FactorsLabor, ObstetricPregnancyReproductionReproductive Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Officials

  • Britt-Ingjerd Nesheim, MD PhD

    Ullevål University Hospital, Oslo, Norway

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 10, 2006

First Posted

August 15, 2006

Study Start

September 1, 2006

Study Completion

May 1, 2007

Last Updated

August 7, 2007

Record last verified: 2007-04

Locations

NO(1)