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

Intrapartum Hemorrhage Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03009994
• Other study ID #: EUR
• Status: Recruiting
• Phase: Phase 2
• First received: January 3, 2017
• Last updated: January 3, 2017
• Start date: September 2016
• Est. completion date: September 2017

Study information

• Verified date: January 2017
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Assiut Medical School Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1024
• Est. completion date: September 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hemorrhage
• Intrapartum Hemorrhage

Intervention

Procedure:
• Repair of uterine incision

• Exteriorization of the uterus

• Non exteriorization of the uterus

Locations

Country	Name	City	State
Egypt	Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative blood loss (mL)		20 minutes	Yes
Primary	Postoperative Hemoglobin (gm/L)		20 minutes	Yes
Secondary	Duration of operation (minutes)		20 minutes	Yes