Home » Trials » SLCTR/2008/012
Efficacy of surgical versus expectant management in incomplete miscarriage
-
SLCTR Registration Number
SLCTR/2008/012
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
Efficacy of surgical versus expectant management in incomplete miscarriage
Public Title of Trial
Effectiveness of surgery versus doing nothing in incomplete abortion
Disease or Health Condition(s) Studied
Incomplete miscarriage
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
None
What is the research question being addressed?
Effectiveness of surgical versus expectant management in incomplete miscarriage ?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Available
Intervention(s) planned
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
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
Primary outcome(s)
|
1.
Compare the efficacy of surgical versus expectant management in incomplete miscarriage |
[] |
Secondary outcome(s)
|
1.
Compare the efficacy of surgical versus expectant management in incomplete miscarriage |
[] |
Target number/sample size
140
Countries of recruitment
Sri Lanka
Anticipated start date
2008-01-01
Anticipated end date
2009-06-30
Date of first enrollment
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
National Science Foundation
Regulatory approvals
Status
Approved
Date of Approval
2006-03-16
Approval number
Not Available
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya |
| Institutional Address: | PO Box 6, Thalagolla Road, Ragama Sri Lanka |
| Telephone: | +94-11-2961267 |
| Email: | erckelaniya@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr Sanjeewa Padumadasa
Probationary Lecturer
Faculty of Medicine, Ragama, Sri Lanka
0777 388 053
2958337
sanjeewapadumadasa@yahoo.com
Contact Person for Public Queries
Dr Sanjeewa Padumadasa
Probationary Lecturer
Faculty of Medicine, Ragama, Sri Lanka
0777 388 053
2958337
sanjeewapadumadasa@yahoo.com
Primary study sponsor/organization
National Science Foundation
47/5, Maitland Place, Colombo 7, Sri Lanka
2696771-3
2694754
info@nsf.ac.lk
www.nsf.ac.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
