Hysteroscopy and Misoprostol Project - Full Text View

Sponsored by:	Ullevaal University Hospital
Information provided by:	Ullevaal University Hospital
ClinicalTrials.gov Identifier:	NCT00363389

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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:

MedlinePlus related topics: Vaginal Bleeding

Drug Information available for: Misoprostol

U.S. FDA Resources

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

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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

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

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

Keywords provided by Ullevaal University Hospital:

Hysteroscopy
Misoprostol
Uterine hemorrhage
Uterine cervix
Dilatation

Study placed in the following topic categories:

Genital Diseases, Female
Dilatation, Pathologic
Uterine Hemorrhage

Misoprostol
Uterine Diseases
Hemorrhage

Additional relevant MeSH terms:

Uterine Hemorrhage
Oxytocics
Misoprostol
Physiological Effects of Drugs
Gastrointestinal Agents
Uterine Diseases
Reproductive Control Agents
Hemorrhage

Abortifacient Agents, Nonsteroidal
Pharmacologic Actions
Genital Diseases, Female
Pathologic Processes
Therapeutic Uses
Abortifacient Agents
Anti-Ulcer Agents

ClinicalTrials.gov processed this record on September 02, 2009