| 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 (in lay language) | Complications of blunt versus sharp expansion of the uterine incision in lower segment caesarean section. A randomized controlled trial. | |
| Acronym, if any | None | |
| Brief title, if any | None | |
| Any
other number(s) assigned to the trial and issuing authoruty, if any (eg. sponsor, other trial registry) |
None | |
| Disease or Health Condition(s) studied | A surgical procedure is assessed | |
| 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. ? | |
| Study design | Randomized controlled trial without blinding | |
| 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. | |
| Target number / sample size | 250 women in each group | |
| Primary outcome(s) | The percentage of number of tears, that extends laterally or inferiorly from the primary incision into the uterine tissue, in each technique. | |
| Primary outcome(s) - time of assessment(s) | ||
| Secondary outcome(s) | 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 surgeons 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. | |
| Secondary outcome(s) - time of assessment(s) | ||
| Countries of recruitment | Sri Lanka | |
| Anticipated start date | 01/05/2009 | |
| Anticipated end date | 01/12/2009 | |
| Recruitment status | Completed | |
| State of ethics review approval | Ethical clearence was granted by the ethical review committee faculty of medicine university of kelaniya (P15/03/2009) | |
| Funding source(s) | Self | |
| Applicant's Email | chandanasj@yahoo.com | |
| Approval Status | Approved | |
| Contact Person for Scientific Queries / Principal investigator | Dr D.M.C.S JAYASUNDARA
Registrar (Obs & Gyn) 229/10, St Josephs Street, Negombo 0714492897 chandanasj@yahoo.com |
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| Primary Study Sponsor/ Organization | Dr D.M.C.S JAYASUNDARA
10 St Josephs Street, Negombo 0714492897 chandanasj@yahoo.com |
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| Contact Person for Public Queries | Dr D.M.C.S JAYASUNDARA Registrar (Obs & Gyn) Colombo North Teaching Hospital, Ragama 0714492897 chandanasj@yahoo.com |
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| Secondary Study Sponsor(s), (if any) | None |
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