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

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.

Study Overview

• Status: Completed
• Conditions: Intrapartum Hemorrhage
• Intervention / Treatment: Procedure: Repair of uterine incision; Procedure: Exteriorization of the uterus; Procedure: Non exteriorization of the uterus

• Study Type: Interventional
• Enrollment (Actual): 1024
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71111
    • Assiut University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Exteriorization group; 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.	Procedure: Repair of uterine incision; Procedure: Exteriorization of the uterus
Other: Non exteriorization group; Uterine incision will be repaired intra abdominally	Procedure: Repair of uterine incision; Procedure: Non exteriorization of the uterus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Intraoperative blood loss (mL)	20 minutes
Postoperative Hemoglobin (gm/L)	20 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
Duration of operation (minutes)	20 minutes

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: January 3, 2017
• First Submitted That Met QC Criteria: January 3, 2017
• First Posted (Estimated): January 4, 2017

Study Record Updates

• Last Update Posted (Actual): July 31, 2024
• Last Update Submitted That Met QC Criteria: July 30, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: EUR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO