Home » Trials » SLCTR/2009/003
Complications of blunt versus sharp expansion of the uterine incision in lower segment caesarean section. A randomized controlled trial.
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SLCTR Registration Number
SLCTR/2009/003
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
Complications of blunt versus sharp expansion of the uterine incision in lower segment caesarean section. A randomized controlled trial.
Public Title of Trial
Complications of blunt versus sharp expansion of the uterine incision in lower segment caesarean section. A randomized controlled trial.
Disease or Health Condition(s) Studied
A surgical procedure is assessed
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
P15/03/2009 (Ethics Review Committee of the Faculty of Medicine, University of Kelaniya)
What is the research question being addressed?
To compare incidence of complications associated with blunt versus sharp expansion of the uterine incision during of caesarean section. ?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Other
Study Phase
Not Available
Intervention(s) planned
Blunt versus sharp expansion of the uterine incision during of caesarean section. ? Sharp expansion method A transverse uterine incision in the lower uterine segment of approximately 2cm in length will be made with the scalpel. The uterine incision will be expanded by cutting laterally and cephalad using curved scissors. ? Blunt expansion method After placing the 2cm transverse incision by scalpel in the lower uterine segment, this will be expanded using the index fingers of both hands placed into the incision and pulling the fingers laterally and cephalad. The remainder of the operation will be performed alike in all patients
Inclusion criteria
All women admitted to antenatal ward have a chance of undergoing a lower segment caesarean section (LSCS). Therefore all consecutive women admitted to the antenatal ward (ward 18, NCTH, Ragama.) for delivery will be informed about the study, consent obtained and included in the study. This will include all mothers who undergo LSCS from the antenatal ward and labour room either as an emergency, urgent, schedule or elective procedure
Exclusion criteria
1) All women who refuse randomization as they prefer either technique will be excluded from the study. 2) Women who have an increased risk of bleeding like • Placental abruption / placenta previa • Uterine fibroid at lower segment • Fever with suspected chorioamnionitis • Inherited / acquired bleeding disorders • Severe PIH on MgSO4 will be excluded as they may interfere with the normal average blood loss. 3) Extreme premature cases where lower segment has not formed will be excluded from the study (less than 28weeks). 4) All women who undergo general anaesthesia will be excluded as this is associated with increased bleeding.
Primary outcome(s)
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1.
The percentage of number of tears, that extends laterally or inferiorly from the primary incision into the uterine tissue, in each technique. |
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Secondary outcome(s)
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1.
1) Percentage reduction in haematocrit between the pre operative value and the value 48hours after operation and calculate the mean reduction in each group. 2) The mean time taken to complete the repair of the incision in either technique. 3) The surgeon’s opinion regarding the ease of repairing the uterine incision will be assessed 4) To assess the incidence of • extensions of the incision into the broad ligament, uterine vessels, and/or cervix in each technique • the need of additional haemostatic sutures to control haemostatsis after repairing the incision • the percentage of complications occurring in either technique when the dilatation of the cervix is less than 4cm, 4cm to 9 cm, 10cm. |
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Target number/sample size
500 (250 per group)
Countries of recruitment
Sri Lanka
Anticipated start date
2009-05-01
Anticipated end date
2009-12-01
Date of first enrollment
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2009-03-24
Approval number
P05/03/2009
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 D.M.C.S JAYASUNDARA
Registrar (Obs & Gyn)
Colombo North Teaching Hospital, Ragama
0714492897
chandanasj@yahoo.com
Contact Person for Public Queries
Dr D.M.C.S JAYASUNDARA
Registrar (Obs & Gyn)
Colombo North Teaching Hospital, Ragama
0714492897
chandanasj@yahoo.com
Primary study sponsor/organization
Dr D.M.C.S JAYASUNDARA
10 St Josephs Street, Negombo
0714492897
chandanasj@yahoo.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
