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Main
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Note: This record shows only the 20 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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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR877 |
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Date of registration:
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23/01/2007 |
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Primary sponsor: |
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Public title:
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Endometrial aspiration before or after Saline Infusion Sonography (SIS) in case of abnormal uterine bleeding; effect on specimen quality.
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Scientific title:
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Endometrial aspiration before or after Saline Infusion Sonography (SIS) in case of abnormal uterine bleeding; effect on specimen quality. - Endometrial aspiration specimen quality after SIS |
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Date of first enrolment:
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1/9/2006 |
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Target sample size:
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120 |
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Recruitment status: |
complete |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=877 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: Single; Control: Not applicable; Group: Parallel; Type: 2 or more arms, randomized
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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A.J.M.
Bij de Vaate |
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Address:
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Department of Obstetrics and Gynaecology
VU University Medical Center
De Boelelaan 1117
1081 HV
Amsterdam
The Netherlands |
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Telephone:
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+31 20 4443613 |
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Email:
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m.bijdevaate@vumc.nl |
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Affiliation:
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Name:
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H.A.M.
Brölmann |
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Address:
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VU University Medical Center
De Boelelaan 1117
Amsterdam
The Netherlands |
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Telephone:
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+31 20 4444851 |
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Email:
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h.brolmann@vumc.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Patiens with abnormal uterine bleeding.
Exclusion criteria: 1. PID;
2. Cervical cancer.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Abnormal uterine bleeding, Saline infusion sonography (SIS) , Endometrial aspiration, Endometrial biopsy
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Intervention(s)
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Saline Infusion Sonography (SIS) and endometrial aspiration are performed with the same catheter in one session. Patients are either allocated to aspiration and subsequent SIS, or to the reverse order.
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Primary Outcome(s)
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Quality assessment of aspiraton specimen by pathologist.
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Secondary Outcome(s)
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Reliability of video SIS-images.
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Secondary ID(s)
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ISRCTN43875039
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N/A
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Source(s) of Monetary Support
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VU University Medical Center, Department of Obstetrics and Gynaecology
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