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

NCT ID: NCT03009994

Last Updated: 2024-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1024 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-01
• Study Completion Date: 2017-12-01

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.

Conditions

Intrapartum Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: OTHER

Repair of uterine incision

Intervention Type: PROCEDURE

Exteriorization of the uterus

Intervention Type: PROCEDURE

Non exteriorization group

Uterine incision will be repaired intra abdominally

Group Type: OTHER

Repair of uterine incision

Intervention Type: PROCEDURE

Non exteriorization of the uterus

Intervention Type: PROCEDURE

Interventions

Repair of uterine incision

Intervention Type: PROCEDURE

Exteriorization of the uterus

Intervention Type: PROCEDURE

Non exteriorization of the uterus

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mohammed Khairy Ali

Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Assiut university

Asyut, , Egypt

Countries

Egypt

Other Identifiers

EUR

Identifier Type: -

Identifier Source: org_study_id