Endometrial Biopsy
Conditions
Keywords
pain/discomfort, cervical dilatation, side effects
Brief summary
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.
Interventions
DRUGmisoprostol
misoprostol 400mcg 12 hrs prior to procedure
DRUGvitamin B6
Vitamin B6 50 mg orally 12 hrs prior to procedure
Sponsors
Memorial University of Newfoundland
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
19 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pain/discomfort of endometrial biopsy | during procedure |
Secondary
| Measure | Time frame |
|---|---|
| ease of performing biopsy | during procedure |
| success of obtaining biopsy | during procedure |
| potential side effects | time study drug taken until procedure |
Countries
Canada
Outcome results
None listed