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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03530488 |
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Date of registration:
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08/05/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Value of Endocervical and Endometrial Lidocaine Flushing Before Office Hystroscopy
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Scientific title:
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The Value of Endocervical and Endometrial Lidocaine Flushing Before Office Hystroscopy |
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Date of first enrolment:
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May 2018 |
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Target sample size:
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250 |
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Recruitment status: |
Unknown status |
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URL:
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https://clinicaltrials.gov/show/NCT03530488 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Investigator, Outcomes Assessor).
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Phase:
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Phase 4
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Countries of recruitment
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Egypt
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Contacts
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Name:
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Ahmed Maged |
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Address:
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Telephone:
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Email:
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Affiliation:
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professor |
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Name:
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Ahmed Maged, MD |
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Address:
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Telephone:
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+2001005227404 |
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Email:
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prof.ahmedmaged@gmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- all women indicated for office hysteroscopy for evaluation of the uterine cavity eg:
AUB, infertility
Exclusion Criteria:
- Women allergic to local anesthesia those required operative hysteroscopy under general
anesthesia pelvic inflammatory disease known cervical malignancy profuse uterine
bleeding, marked cervical stenosis recent uterine perforation previous cervical
surgery and neurological disorders affecting evaluation of pain using other products
that could affect the consistency of the cervix such as local estrogen, misoprostol or
laminaire are contraindications for office hystroscopy
Age minimum:
20 Years
Age maximum:
45 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Pain During Hystroscopy
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Intervention(s)
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Drug: Lidocaine
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Procedure: Office hystroscopy
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Primary Outcome(s)
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Pain assessment during the hysteroscopy
[Time Frame: during hystroscopy procedure]
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Secondary Outcome(s)
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Pain assessment 60 minutes after hysteroscopy
[Time Frame: 60 minutes after hysteroscopy]
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Pain assessment 10 minutes after hysteroscopy
[Time Frame: 10 minutes after hysteroscopy]
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Pain assessment 30 minutes after hysteroscopy
[Time Frame: 30 minutes after hysteroscopy]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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