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Exteriorization Versus Non-exteriorization of the Uterus During Repair of Uterine Incision in a Repeated Cesarean Section

Primary Purpose

Intrapartum Hemorrhage

Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Repair of uterine incision
Exteriorization of the uterus
Non exteriorization of the uterus
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intrapartum Hemorrhage

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Pregnant women in 28 weeks
  • Women who will undergo repeated lower segment cesarean section

Exclusion Criteria:

  • First cesarean section
  • Placenta previa.
  • Rupture uterus.
  • Classical caesarean section.(upper segment cesarean section)
  • Sever Preeclampsia.
  • Chorioamnionitis.
  • prolonged or obstructed labour.
  • Fibroid.
  • Polyhydramnios.
  • Multiple pregnancy.

Sites / Locations

  • Assiut universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Exteriorization group

Non exteriorization group

Arm Description

After delivery of the fetus and placenta, the surgeon bring uterus yet out from peritoneal cavity by manual handling of the uterus uterus from fundus and extracted out of the abdominal cavity before starting to close it. After repair of the uterus , uterus returned to abdominal cavity and repair anterior abdominal wall as following.

Uterine incision will be repaired intra abdominally

Outcomes

Primary Outcome Measures

Intraoperative blood loss (mL)
Postoperative Hemoglobin (gm/L)

Secondary Outcome Measures

Duration of operation (minutes)

Full Information

First Posted
January 3, 2017
Last Updated
January 3, 2017
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03009994
Brief Title
Exteriorization Versus Non-exteriorization of the Uterus During Repair of Uterine Incision in a Repeated Cesarean Section
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
August 2017 (Anticipated)
Study Completion Date
September 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Cesarean section is one of the most frequently performed major operations worldwide. It accounts for between 1% and 70% of deliveries depending on the facilities or country assessed. In Egypt, the cesarean section rate is 22%, with higher rates seen in private hospitals. In 2015 ,incidence of cesarean section rate in Woman Health Hospital in Assiut university is 51.3% of all deliveries. Different Operational techniques For cesarean section have been defined aimed at reducing surgical time, making the surgery easier and more efficient, lowering costs,decreasing the risk of adverse effects and postoperative morbidity, as well as length of hospital stay. Also, Intraoperative blood loss is one of important complications during cesarean section. A systematic review included twenty one studies, in 2011, revealed that increase incidence of intraoperative blood loss and blood transfusion with increase number of cesarean deliveries.also anemia in the pregnancy increase maternal morbidities included intraoperative blood loss. In Egypt, prevalence of Iron deficiency anemia among pregnant women about 51% of pregnant women. After baby born by cesarean section and the placenta has been extracted, uterine incision is sutured either by temporary removal of the uterus from the abdominal cavity (exteriorization of the uterus) to facilitate uterine incision repair or it is repaired within the abdominal cavity (in situ repair). There had been few randomized controlled trials comparing intraoperative and postoperative morbidity following exteriorization of the uterus with non-exteriorization. The conclusions drawn from these trials have been conflicting.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intrapartum Hemorrhage

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1024 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exteriorization group
Arm Type
Other
Arm Description
After delivery of the fetus and placenta, the surgeon bring uterus yet out from peritoneal cavity by manual handling of the uterus uterus from fundus and extracted out of the abdominal cavity before starting to close it. After repair of the uterus , uterus returned to abdominal cavity and repair anterior abdominal wall as following.
Arm Title
Non exteriorization group
Arm Type
Other
Arm Description
Uterine incision will be repaired intra abdominally
Intervention Type
Procedure
Intervention Name(s)
Repair of uterine incision
Intervention Type
Procedure
Intervention Name(s)
Exteriorization of the uterus
Intervention Type
Procedure
Intervention Name(s)
Non exteriorization of the uterus
Primary Outcome Measure Information:
Title
Intraoperative blood loss (mL)
Time Frame
20 minutes
Title
Postoperative Hemoglobin (gm/L)
Time Frame
20 minutes
Secondary Outcome Measure Information:
Title
Duration of operation (minutes)
Time Frame
20 minutes

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pregnant women in 28 weeks Women who will undergo repeated lower segment cesarean section Exclusion Criteria: First cesarean section Placenta previa. Rupture uterus. Classical caesarean section.(upper segment cesarean section) Sever Preeclampsia. Chorioamnionitis. prolonged or obstructed labour. Fibroid. Polyhydramnios. Multiple pregnancy.
Facility Information:
Facility Name
Assiut university
City
Assiut
ZIP/Postal Code
71111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammed k Ali, MD
Phone
+20100553751
Email
m_khairy2001@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Exteriorization Versus Non-exteriorization of the Uterus During Repair of Uterine Incision in a Repeated Cesarean Section

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