Home » Trials » SLCTR/2017/023
Safety and effectiveness of vacuum aspiration, compared to curettage for management of patients with first trimester miscarriage in a limited resource setting in Sri Lanka.
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SLCTR Registration Number
SLCTR/2017/023
Date of Registration
The date of last modification
Mar 03, 2019
Scientific Title of Trial
Safety and effectiveness of vacuum aspiration, compared to curettage for management of patients with first trimester miscarriage in a limited resource setting in Sri Lanka.
Public Title of Trial
Safety and effectiveness of vacuum aspiration, compared to curettage for management of patients with first trimester miscarriage in a limited resource setting in Sri Lanka.
Disease or Health Condition(s) Studied
Miscarriage
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1198-2573
Any other number(s) assigned to the trial and issuing authority
EC-17-037 (ERC: Colombo)
What is the research question being addressed?
Is vacuum aspiration a safe and effective method when compared to curettage method, in managing patients with first trimester miscarriage in a limited resource setting in Sri Lanka ?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Single blinded
Control
Active
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 2-3
Intervention(s) planned
The study will be conducted at Ward 17, De Zoysa Maternity Hospital, Colombo 8, Sri Lanka.
Simple randomization will be used to allocate eligible participants to the study arms.
The intervention arm will receive vacuum aspiration of the retained products of conception. Suction evacuation will be done using a manual vacuum aspirator under analgesic cover without using anaesthesia, as an in-ward procedure. Efforts will be taken to avoid the usage of Hegar’s dilators.
The control arm will receive curettage of the retained products of conception. Surgical evacuation will be done using metal curette under general anesthesia in the Operation Theater. Hegar’s dilators will be used to dilate the cervix.
Standard monitoring and supportive care including uterotonics, antibiotics, anti-D immunoglobulin and blood transfusion will be provided to both arms based on standard guidelines. Ultra sound guided surgical evacuation under general anaesthesia will be provided if complete evacuation is not achieved. The data analysts will be blinded to the intervention status.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
Estimated blood loss and need for blood transfusion - using visual estimation of the number of soaked towels or sanitary pads and amount of blood clots in kidney tray, and haemoglobin concentration 24 hours post-procedure. |
[ Immediately post procedure, and at the end of 24 hours. ] |
|
2.
Need for repeated evacuation (endometrial thickening more than 10mm on ultra sound scan of the abdomen at 12 hours post-procedure) |
[ 12 hours post procedure ] |
|
3.
Post-operative pain using a visual pain analogue scale. |
[ 6 hours post procedure ] |
|
4.
Cervical trauma (on visualization of the cervix post-procedure) |
[ Immediately post procedure ] |
|
5.
Duration of procedure (in minutes) |
[ At the end of the procedure. ] |
|
6.
Duration of hospital stay |
[ At discharge ] |
Secondary outcome(s)
|
1.
None |
[ None ] |
Target number/sample size
136 (68 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2017-07-24
Anticipated end date
2018-07-24
Date of first enrollment
2017-07-24
Date of study completion
Recruitment status
Recruiting
Funding source
None (Investigator funded)
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2018-06-15
Approval number
EC-17-037
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Colombo |
| Institutional Address: | No. 25, Kynsey Road, Colombo 00800 Sri Lanka |
| Telephone: | +94-11-2695300 (Extension: 240) |
| Email: | ethicscommitteemfc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. E. Ethayarooban
Registrar in Obstetrics and Gynaecology
Post Graduate Institute of Medicine
Colombo 7, Sri Lanka
Mob: 0714289878 / 0776257989
roobanethayan@gmail.com
Contact Person for Public Queries
Dr. (Mrs) P. GowrySenthilnathan
Consultant Obstetrician and Gynaecologist
De Soysa Hospital for Women Colombo 08
Sri Lanka
Tel: 0112726775
Mob: 0777873244
gowrysenthilnathan@yahoo.com
Primary study sponsor/organization
De Zoysa Hospital for Women
Colombo 8
Sri Lanka
Tel: 0112662619-23
Fax: 0112697315
http://www.dmh.health.gov.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
