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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03224247
Other study ID # Vertical splitting in CS
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date January 1, 2021
Est. completion date December 1, 2021

Study information

Verified date January 2021
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 400
Est. completion date December 1, 2021
Est. primary completion date December 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 35 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Transverse cutting
Transverse cutting and/or pulling.of lower uterine segment during lower cesarean section extending the uterine incision laterally.
vertical splitting
vertical splitting of lower uterine segment during lower cesarean section making the direction of traction up and downward instead of being laterally and we suppose that this will allow 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.

Locations

Country Name City State
Egypt Ahmed Abass Cairo

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Uterine vessels injury the surgeon performing the cesarean section will detect if injury of uterine vessels occurred or not while extending uterine incision. 1 minute after extraction of the baby and placenta
Secondary uterine incision extension the surgeon performing the cesarean section will detect if uterine incision extension occurred or not after extraction of the baby and the placenta. 2 minutes extraction of the baby and placenta
Secondary intra-operative blood loss blood loss will be assessed by circulating nurse through counting soaked surgical towels and gauze and calculating estimated blood loss in vacation suction system. before closure of the abdominal wall layer
Secondary postpartum hemorrhage will be defined by postpartum blood loss of 1000cc first 24 hours after delivery
Secondary postoperative pain pain scale from 0 to 10 to assess postoperative pain after delivery 2 hours after delivery
Secondary postoperative pain pain scale from 0 to 10 to assess postoperative pain at hours 2 after delivery 6 hours after delivery
Secondary postoperative pain pain scale from 0 to 10 to assess postoperative pain at hours 2 after delivery 12 hours after delivery
Secondary postoperative pain pain scale from 0 to 10 to assess postoperative pain at hours 2 after delivery 24 hours after delivery
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