Complications of blunt versus sharp expansion of the uterine incision in lower segment caesarean section. A randomized controlled trial.

• Register: SLCTR
• Last refreshed on: 27 April 2013
• Main ID: SLCTR/2009/003
• Date of registration: 15/05/2009
• Primary sponsor: Dr D.M.C.S JAYASUNDARA
• Public title: Complications of blunt versus sharp expansion of the uterine incision in lower segment caesarean section. A randomized controlled trial.
• Scientific title: Complications of blunt versus sharp expansion of the uterine incision in lower segment caesarean section. A randomized controlled trial.
• Date of first enrolment: 1/5/2009
• Target sample size: 250 women in each group
• Recruitment status: Completed
• URL: http://www.slctr.lk/trial_details.asp?reg_id={E63E388A-63A2-4F22-A710-7BCAF4F58F98}
• Study type: Interventional
• Study design: Randomized controlled trial without blinding

Countries of recruitment

Sri Lanka

Contacts

• Name: Dr D.M.C.S JAYASUNDARA
• Affiliation: Registrar (Obs and Gyn)

• Name: Dr D.M.C.S JAYASUNDARA
• Affiliation: Registrar (Obs and Gyn)

Key inclusion & exclusion criteria

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.


Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

A surgical procedure is assessed

Intervention(s)

Blunt versus sharp expansion of the uterine incision during of caesarean section.
and#61558; 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.

and#61558; 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

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.

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 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.

Secondary ID(s)

None

Source(s) of Monetary Support

Self