NCT03224247

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 21, 2017

Completed
3.5 years until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

January 20, 2021

Status Verified

January 1, 2021

Enrollment Period

11 months

First QC Date

July 15, 2017

Last Update Submit

January 16, 2021

Conditions

Cesarean Section Complications

Keywords

vertical splittingCesarean Section Complicationsuterine vesselsinjury

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • uterine incision extension

    2 minutes extraction of the baby and placenta

  • intra-operative blood loss

    before closure of the abdominal wall layer

  • postpartum hemorrhage

    first 24 hours after delivery

  • postoperative pain

    2 hours after delivery

  • postoperative pain

    6 hours after delivery

  • +2 more secondary outcomes

Study Arms (2)

Transverse splitting

ACTIVE COMPARATOR

transverse cutting and/or pulling of lower uterine segment during lower segment cesarean section.

Procedure: Transverse cutting

Vertical splitting

ACTIVE COMPARATOR

vertical splitting,of lower uterine segment during lower segment cesarean section.

Procedure: vertical splitting

Interventions

Transverse cuttingPROCEDURE

Transverse cutting and/or pulling.of lower uterine segment during lower cesarean section extending the uterine incision laterally.

Transverse splitting
vertical splittingPROCEDURE

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.

Vertical splitting

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Abass

Cairo, 11311, Egypt

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Waled Hitler, Prof

    AinShams University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

July 15, 2017

First Posted

July 21, 2017

Study Start

January 1, 2021

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

January 20, 2021

Record last verified: 2021-01

Locations

EG(1)