Home » Trials » SLCTR/2008/011
Surgical treatment vs expectant care in the management of incomplete miscarriage
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SLCTR Registration Number
SLCTR/2008/011
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
Surgical treatment vs expectant care in the management of incomplete miscarriage
Public Title of Trial
Is evacuation of retained products of conception routinely required for incomplete miscarriage?
Disease or Health Condition(s) Studied
First trimester 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?
Can expectant care in the management of incomplete miscarriage safely reduce the need for surgical interventions without significantly increasing any adverse effects?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Active
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Available
Intervention(s) planned
Not carrying out surgical evacuation in the study group and routine surgical evacuation in the control group
Inclusion criteria
Consecutive women presenting within three (3) days of bleeding with spontaneous miscarriage at a period of gestation of 14 weeks or less and trans vaginal ultrasound diameter of retained products of conception between 15 mm to 50 mm
Exclusion criteria
Women who have strong preference to either management, any other complicating medical conditions, cervical incompetence and induced abortions and evidence of induced abortion
Primary outcome(s)
|
1.
In the study group percentage reduction in the population of women with incomplete miscarriages who will require a surgical evacuation |
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Secondary outcome(s)
|
1.
Excessive bleeding, need for surgical evacuation, infections, pain, cervical or uterine injuries, duration of vaginal bleeding, time off normal work, duration of hospital stay |
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Target number/sample size
144
Countries of recruitment
Sri Lanka
Anticipated start date
2008-03-24
Anticipated end date
2009-02-23
Date of first enrollment
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2008-01-14
Approval number
Not Available
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Ruhuna |
| Institutional Address: | PO Box 70, Labuduwa Rd, Galle, Sri Lanka |
| Telephone: | +94-91-2234801/803 (Extension: 161) |
| Email: | ethics@med.ruh.ac.lk |
Contact person for Scientific Queries/Principal Investigator
Prof. Malik Goonewardene
Professor & Head, Department of Obstetrics & Gynaecology
Faculty of Medicine, Galle.
(091)2246878, 2234801/3
(091)2222314
malikg@eureka.lk
Contact Person for Public Queries
Prof. Malik Goonewardene
Professor & Head, Department of Obstetrics & Gynaecology
Faculty of Medicine, Galle.
(091)2246878, 2234801/3
(091)2222314
malikg@eureka.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
