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Hysteroscopy and Misoprostol Project

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00363389
First Posted: August 15, 2006
Last Update Posted: August 7, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Ullevaal University Hospital
  Purpose
To investigate if self-inserted vaginal misoprostol prior to outpatient hysteroscopy will lead to satisfactory cervical ripening, compared to placebo.

Condition Intervention Phase
Uterine Hemorrhage Drug: misoprostol and cervical ripening Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Self-Administered Vaginal Misoprostol at Home for Cervical Ripening Prior to Outpatient Hysteroscopy: a Randomised Placebo-Controlled Trial.

Resource links provided by NLM:


Further study details as provided by Ullevaal University Hospital:

Primary Outcome Measures:
  • 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. [ Time Frame: 24 hours ]

Secondary Outcome Measures:
  • The 60% of premenopausal women achieved satisfactory cervical priming (cervical dilatation ≥ 5 mm) preoperatively, compared to 40% in the placebo group. [ Time Frame: 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". [ Time Frame: 24 hours ]
  • Frequency of complications: 11%. [ Time Frame: 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. [ Time Frame: 24 hours ]

Enrollment: 86
Study Start Date: September 2006
Study Completion Date: May 2007
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 73 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Women who are unable to communicate in Norwegian
  • Women with a known allergy to misoprostol
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00363389


Locations
Norway
Gynaecological Department, Ullevål University Hospital
Oslo, Norway, N-0407
Sponsors and Collaborators
Ullevaal University Hospital
Investigators
Study Chair: Britt-Ingjerd Nesheim, MD PhD Ullevål University Hospital, Oslo, Norway
  More Information

ClinicalTrials.gov Identifier: NCT00363389     History of Changes
Other Study ID Numbers: 2006-001201-28
First Submitted: August 10, 2006
First Posted: August 15, 2006
Last Update Posted: August 7, 2007
Last Verified: April 2007

Keywords provided by Ullevaal University Hospital:
Hysteroscopy
Misoprostol
Uterine hemorrhage
Uterine cervix
Dilatation

Additional relevant MeSH terms:
Hemorrhage
Uterine Hemorrhage
Pathologic Processes
Uterine Diseases
Genital Diseases, Female
Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics


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