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CompletedNCT03009994Updated Jul 31, 2024

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

An interventional study of Repair of uterine incision and Exteriorization of the uterus in Intrapartum Hemorrhage, sponsored by Assiut University. Completed at 1 site in Egypt. Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2024-07-31.

Sponsored by Assiut University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Sep 2016, registered Jan 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
1,024
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Intrapartum Hemorrhage

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03

In context

Hemorrhage

3,000 studies on the registry are indexed under Hemorrhage; 474 are open to participants now.

This study's enrollment of 1,024 is above the median of 100 across 1,985 interventional studies indexed under Hemorrhage.

Browse Hemorrhage studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
1,024 participants (actual)

Study arms

  • 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

Interventions

  • ProcedureRepair of uterine incision
  • ProcedureExteriorization of the uterus
  • ProcedureNon exteriorization of the uterus
06

What researchers measure

Primary outcomes

  1. Intraoperative blood loss (mL)

    Time frame: 20 minutes

  2. Postoperative Hemoglobin (gm/L)

    Time frame: 20 minutes

Secondary outcomes

  1. Duration of operation (minutes)

    Time frame: 20 minutes

07

Study locations

1 site
  • Assiut university
    Assiut, 71111, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03009994
Lead sponsor
Assiut University
Responsible party
Mohammed Khairy Ali (Prof, Assiut University) — Principal investigator
First posted
Jan 4, 2017
Start date
Sep 1, 2016
Primary completion
Aug 1, 2017
Completion
Dec 1, 2017
Last update
Jul 31, 2024

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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