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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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16 December 2017 |
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Main ID: |
NCT02543515 |
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Date of registration:
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29/08/2015 |
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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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Psychosocial and Clinical Characteristics Predicting Women's Acceptance of Office Hysteroscopy
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Scientific title:
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Psychosocial and Clinical Characteristics Predicting Women's Acceptance of Office Hysteroscopy: An Observational Study |
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Date of first enrolment:
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March 2015 |
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Target sample size:
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100 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02543515 |
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Study type:
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Observational [Patient Registry] |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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Portugal
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Contacts
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Name:
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Antonio Paulo, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centro Hospitalar Tondela-Viseu |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- women scheduled for office hysteroscopy Written informed consent; diagnosis of uterine
abnormal bleeding, sonographic evidence of thickened endometrium, sterility workup,
endometrial polyps or sub mucous myoma, foreign body extraction or insertion (i.e.
sterilization) or other condition with indication for procedure and who meet study
eligibility criteria; ability to fill in the study questionnaires.
Exclusion Criteria:
- refusal to participate in study innability to fill in the study questionnaires
Age minimum:
18 Years
Age maximum:
90 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Pelvic Girdle Pain
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Intervention(s)
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Procedure: office hysteroscopy
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Primary Outcome(s)
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office hysteroscopy in previous C section and repeat C section
[Time Frame: five to ten minutes after hystersocopy]
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office hysteroscopy in parous women
[Time Frame: five to ten minutes after hystersocopy]
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office hysteroscopy in Nuligest
[Time Frame: five to ten minutes after hystersocopy]
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Secondary Outcome(s)
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office hysteroscopy in women with previous surgery upon uterine cervix
[Time Frame: five to ten minutes after hystersocopy]
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office hysteroscopy in women with history of dysmenorrhea
[Time Frame: five to ten minutes after hystersocopy]
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office hysteroscopy and body mass index
[Time Frame: five to ten minutes after hystersocopy]
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office hysteroscopy and psychosocial profile (State-Trait Anxiety Inventory for Adults)
[Time Frame: five to ten minutes after hystersocopy]
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office hysteroscopy in post-menopausal women
[Time Frame: five to ten minutes after hystersocopy]
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office hysteroscopy in women with abnormal uterine bleeding
[Time Frame: five to ten minutes after hystersocopy]
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Women's Satisfaction with office hysteroscopy according to pain perceived
[Time Frame: five to ten minutes after hystersocopy]
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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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