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Hysteroscopy and Misoprostol Project

This study has been completed.
Sponsor:
Information provided by:
Ullevaal University Hospital
ClinicalTrials.gov Identifier:
NCT00363389
First received: August 10, 2006
Last updated: August 6, 2007
Last verified: April 2007
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   18 Years to 73 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00363389     History of Changes
Other Study ID Numbers: 2006-001201-28
Study First Received: August 10, 2006
Last Updated: August 6, 2007
Health Authority: Norway: Norwegian Medicines Agency

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

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

ClinicalTrials.gov processed this record on November 25, 2014