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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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SLCTR |
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Last refreshed on:
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27 April 2013 |
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Main ID: |
SLCTR/2008/012 |
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Date of registration:
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20/06/2008 |
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Primary sponsor: |
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Public title:
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Effectiveness of surgery versus doing nothing in incomplete abortion
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Scientific title:
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Efficacy of surgical versus expectant management in incomplete miscarriage |
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Date of first enrolment:
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1/1/2008 |
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Target sample size:
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140 |
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Recruitment status: |
Completed |
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URL:
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http://www.slctr.lk/trial_details.asp?reg_id={E45C75BE-D7B6-4000-BAC5-A4CA207F5F94} |
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Study type:
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Interventional |
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Study design:
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Randomised clinical trial
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Countries of recruitment
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Sri Lanka
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Contacts
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Name:
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Dr Sanjeewa Padumadasa
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Address:
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Faculty of Medicine, Ragama
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Telephone:
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0777 388 053 |
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Email:
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sanjeewapadumadasa@yahoo.com |
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Affiliation:
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Probationary Lecturer |
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Name:
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Dr Sanjeewa Padumadasa
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Address:
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Faculty of Medicine, Ragama, Sri Lanka
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Telephone:
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0777 388 053 |
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Email:
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sanjeewapadumadasa@yahoo.com |
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Affiliation:
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Probationary Lecturer |
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Key inclusion & exclusion criteria
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Inclusion criteria: Women with an incomplete miscarriage with retained products less than 50mm AP diameter
Exclusion criteria: Women with a strong preference for either intervention, women with profuse bleeding, severe pain or fever necessitating immediate surgical intervention will be exclude from the study
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Incomplete miscarriage
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Intervention(s)
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Randomise the study population into a surgical group where they will undergo evacuation of retained products of conception or an expectant group where they will be followed up weekly for six weeks clinically and using ultrasound of pelvis
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Primary Outcome(s)
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Compare the efficacy of surgical versus expectant management in incomplete miscarriage
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Secondary Outcome(s)
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•To assess the rate of complications with thetwo treatment modalities
•To evaluate patient acceptance of the two methods
•To perform a cost analysis of the two methods
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Secondary ID(s)
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RG/2007/HS/07
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Source(s) of Monetary Support
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National Science Foundation
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