Clinical trial NCT03224247: Vertical Splitting of Muscle Layer in Lower Segment Cesarean Sections to Avoid Uterine Vessels Injury
Official title: Comparison Between Vertical Splitting Versus Transverse Cutting of Muscle Layer in Lower Segment Cesarean Sections to Avoid Uterine Vessels Injury: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cesarean Section Complications
Keywords: vertical splitting
Cesarean Section Complications
uterine vessels
injury
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2017-07-21
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Cesarean section is one of the oldest surgical interventions in the history of medicine.Many variations in cesarean section technique have been studied.The investigatory team are aiming to decrease blood loss during cesarean section by vertical splitting versus transverse cutting of muscle layer in lower segment cesarean sections to avoid uterine vessels injury.

Detailed description: Cesarean section is one of the oldest surgical interventions in the history of medicine.Since the first documented cesarean delivery in 1020 AD, various modifications have been made in the technique. It was a surgery performed as a last resort, mostly peri- or post-portem.

Many variations in cesarean section technique have been studied.our study aim is to decrease blood loss during cesarean section through decreasing incidence of uterine vessels injury. The investigator supposed that applying Vertical pull on a small C-shaped incision in the lower uterine segment during cesarean section allows the tissues to split along their natural arrangement, decreasing the probability of extension of the wound into the uterine vessels, thus; decreasing blood loss; operative time and maternal recovery.

Eligibility criteria: Inclusion Criteria:

* Elective cesarean section
* No medical disorders during pregnancy ( Hypertension, DM , ..)
* No coagulation disorders either congenital nor acquired.

Exclusion Criteria:

* Urgent or emergency cesarean section.
* Multiple pregnancy.
* Presence of medical disorders during pregnancy ( Hypertension, DM , ..)
* Presence of coagulation disorders either congenital nor acquired.

Primary outcomes:
measure: Uterine vessels injury
timeFrame: 1 minute after extraction of the baby and placenta
Secondary outcomes:
measure: uterine incision extension
timeFrame: 2 minutes extraction of the baby and placenta
measure: intra-operative blood loss
timeFrame: before closure of the abdominal wall layer
measure: postpartum hemorrhage
timeFrame: first 24 hours after delivery
measure: postoperative pain
timeFrame: 2 hours after delivery
measure: postoperative pain
timeFrame: 6 hours after delivery
measure: postoperative pain
timeFrame: 12 hours after delivery
measure: postoperative pain
timeFrame: 24 hours after delivery
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ahmed Abass
Study officials:
affiliation: AinShams University
name: Waled Hitler, Prof
role: STUDY_DIRECTOR
References: