Complications of blunt versus sharp expansion of the uterine incision in lower segment caesarean section. A randomized controlled trial.
- Conditions
- A surgical procedure is assessed
- Registration Number
- SLCTR/2009/003
- Lead Sponsor
- Dr D.M.C.S JAYASUNDARA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow up complete
- Sex
- Not specified
- Target Recruitment
- Not specified
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The percentage of number of tears, that extends laterally or inferiorly from the primary incision into the uterine tissue, in each technique.<br> []<br>
- Secondary Outcome Measures
Name Time Method 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.<br> []<br>