Home » Trials » SLCTR/2017/014
Effectiveness of manual vacuum aspiration when compared to expectant care in achieving complete miscarriage in women with first trimester pregnancy loss- A Randomized Controlled Trial.
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SLCTR Registration Number
SLCTR/2017/014
Date of Registration
The date of last modification
Mar 03, 2019
Scientific Title of Trial
Effectiveness of manual vacuum aspiration when compared to expectant care in achieving complete miscarriage in women with first trimester pregnancy loss- A Randomized Controlled Trial.
Public Title of Trial
A study on the effectiveness of manual vacuum aspiration when compared to expectant care in achieving complete evacuation of uterus in women with early pregnancy loss
Disease or Health Condition(s) Studied
Miscarriage
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1195-1718
Any other number(s) assigned to the trial and issuing authority
J/ERC/16/76/DR/0036 (ERC: Jaffna)
What is the research question being addressed?
What is the effectiveness of manual vacuum aspiration when compared to expectant care in achieving complete miscarriage in women with first trimester pregnancy loss?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Active
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Applicable
Intervention(s) planned
The study will be carried out at Teaching Hospital Jaffna.
Participants meeting the inclusion/exclusion criteria will be allocated to the study arms using simple randomization.
Arm 1 (intervention arm): Manual Vacuum Aspiration The procedure will be done under local anaesthesia (para cervical block) or sedation. Manual Vacuum Aspiration will be performed using a flexible cannula attached to a 60ml syringe (aspirator), with a double locking valve mechanism. at 12 hours post procedure participants will be offered ultrasound scan to assess the complete evacuation.
Arm 2 (control arm): Expectant care Participants will be educated regarding the expectant care and will be allowed to go home. Follow up will take place on day 7 and 14 with ultrasound scan to assess complete evacuation.
Standard of care: dilatation and curettage under general anaesthesia will be offered to both arms when the complete miscarriage not achieved.
Inclusion criteria
A diagnosis of pregnancy loss will be made when Mean gestational sac diameter exceeds 20 mm in the absence of a yolk sac or embryo and absence of fetal cardiac activity as determined by observing the area of the fetal heart for at least 30 seconds
Gestational age at 12 weeks or less
Haemodynamically stable.
Temperature not more than 37.5 degrees Celsius
No history or concurrent acute medical or surgical condition.
Legally married woman
Not taking anticoagulants or corticosteroids
Not on intrauterine device
Exclusion criteria
Primary outcome(s)
|
1.
Rate of complete miscarriage |
[ At 12 hours post procedure in the manual vacuum aspiration arm; At Day 7 and 14 in the expectant care arm ] |
Secondary outcome(s)
|
1.
Unplanned surgical evacuatio |
[ At 12 hours post procedure in the manual vacuum aspiration arm; At Day 14 in the expectant care arm ] |
|
2.
Patient satisfaction (assessed using a customized questionnaire) |
[ At the end of the primary out come in each arm ] |
|
3.
Need for blood transfusion (haemoglobin level less than 8.0g/dl at the end of two weeks for expectant care and 12 hours after procedure for manual vacuum aspiration.) |
[ At 12 hours post procedure in the manual vacuum aspiration arm; At Day 14 in the expectant care arm ] |
|
4.
Complications a) Pain and pain relief (Score on a 10 point Visual Analogue Scale scale, dose and frequency of analgesics) b) Pelvic infection (temperature > 98.6 degrees Celcius; elevated white cell count (>11,000mm3); c- reactive protein >5) c) Reduction in the Haemoglobin level d) Uterine or cervical damage (By laparoscopy and vaginal examination) |
[ a) Pain and pain relief (Score on a 10 point Visual Analogue Scale scale, dose and frequency of analgesics) Up to 24 hours post procedure in the manual vacuum aspiration arm At Day 14 in the expectant care arm b) Pelvic infection At any readmission with symptoms in the manual vacuum aspiration arm (up to day 14 post procedure) Up to day 14 in the expectant care arm c) Reduction in the Haemoglobin level At baseline and prior to 12 hours post procedure in the manual vacuum aspiration arm At Day 7 or 14 in the expectant care arm d) Uterine or cervical damage: Up to 24 hours post procedure in the manual vacuum aspiration arm Not measured in the expectant care arm ] |
|
5.
Duration of hospital stay |
[ At time of discharge ] |
Target number/sample size
134 (67 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2017-05-30
Anticipated end date
2018-01-01
Date of first enrollment
2017-06-10
Date of study completion
Recruitment status
Recruiting
Funding source
None (investigator funded)
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2017-01-16
Approval number
J/ERC/16/76/DR/0036)
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Jaffna |
| Institutional Address: | ERC Office, Faculty of Medicine, University of Jaffna, Adiyapatham Road, Kokuvil, Jaffna Sri Lanka |
| Telephone: | +94-212222073 (Extension: 342) |
| Email: | ercmedjfn@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. R.Sutharshan
Registrar in Obstetrics and Gynaecology
Teaching Hospital Jaffna,
Hospital Street, Jaffna 40000
Sri Lanka
Tel: 021 222 2261
Mob: 0779232310
sutharshan11@gmail.com
Contact Person for Public Queries
Dr. K. Sureshkumar
Consultant Obstetrician and Gynaecologist
Teaching Hospital Jaffna,
Hospital Street, Jaffna 40000
Sri Lanka
Mob: 0777256683.
vasuresh2003@yahoo.com
Primary study sponsor/organization
Teaching Hospital Jaffna
Hospital Street, Jaffna 40000
Sri Lanka
021 222 2261
thjaffna@gmail.com
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
