Endometrial Biopsy Clinical Trial
Official title:
Oral Misoprostol Before Endometrial Biopsy
Verified date | September 2007 |
Source | Memorial University of Newfoundland |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
An endometrial biopsy involves a thin tube being passed through the cervix (opening of the uterus) to obtain a sample of the lining of the uterus. Sometimes there may be discomfort with this procedure especially if the cervix is not dilated or opened. Previous research has suggested that taking a drug called misoprostol may help the cervix to start to dilate or open. This study will see if misoprostol will help open the cervix for an endometrial biopsy, to lessen the discomfort and make the biopsy easier to perform.
Status | Completed |
Enrollment | 72 |
Est. completion date | September 2007 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 19 Years and older |
Eligibility |
Inclusion Criteria: - women 19 years and older - planned endometrial biopsy Exclusion Criteria: - known hypersensitivity or allery to prostaglandins - seizure disorder - liver disease - known abnormal liver function tests - pregnancy |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Obstetrics and Gynecology Associates | Dartmouth | Nova Scotia |
Canada | Women's Health Centre, Eastern Health | St. John's | Newfoundland and Labrador |
Lead Sponsor | Collaborator |
---|---|
Memorial University of Newfoundland |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | pain/discomfort of endometrial biopsy | during procedure | ||
Secondary | ease of performing biopsy | during procedure | ||
Secondary | success of obtaining biopsy | during procedure | ||
Secondary | potential side effects | time study drug taken until procedure |
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