Back to resultsInternal Iliac Artery Ligation Before Cesarean Hysterectomy in Morbidly Adherent Placenta
Primary Purpose
Blood Loss
Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Internal iliac artery ligation
cesarean hysterectomy
Sponsored by
About this trial
This is an interventional prevention trial for Blood Loss focused on measuring Internal iliac artery, Internal iliac artery ligation, Placenta previa, Placenta accreta, cesarean hysterectomy
Eligibility Criteria
Inclusion Criteria:
- Placenta previa accreta
- Previous 2 cesarean section
- completed her family
- Hemoglobin > 11 gm/dl
- Elective cesarean hysterectomy
Exclusion Criteria:
- Anemia ( Hemoglobin < 11 gm/dl)
- Not completed her family
- BMI > 35 Kg/m2
- Bleeding tendency
- Emergengy cesarean section
- Thrombophilia
Sites / Locations
- Ain Shams University Maternity Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
internal iliac artery ligation + cesarean hysterectomy
cesarean hysterectomy
Arm Description
Outcomes
Primary Outcome Measures
Amount of blood loss
Amount of Blood transfusion needed in mililiters
Secondary Outcome Measures
change of hemoglobin
change of hematocrit
operative time
incidence of injury of important structures during operation
incidence of injury of important structures during operation as urinary bladder, ureteric, intestinal or great vessels injury
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03824873
Brief Title
Internal Iliac Artery Ligation Before Cesarean Hysterectomy in Morbidly Adherent Placenta
Official Title
Internal Iliac Artery Ligation Before Cesarean Hysterectomy in Morbidly Adherent Placenta: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
January 1, 2020 (Actual)
Study Completion Date
July 2, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
40 pregnant females at term diagnosed with morbidly adherent placenta and planned for elective cesarean section were recruited and randomized to 2 groups. Group A: Internal iliac ligation followed by cesarean hysterectomy. Group B: cesarean hysterectomy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss
Keywords
Internal iliac artery, Internal iliac artery ligation, Placenta previa, Placenta accreta, cesarean hysterectomy
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
internal iliac artery ligation + cesarean hysterectomy
Arm Type
Active Comparator
Arm Title
cesarean hysterectomy
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Internal iliac artery ligation
Other Intervention Name(s)
cesarean hysterectomy
Intervention Description
Internal iliac artery ligation and cesarean hysterectomy
Intervention Type
Procedure
Intervention Name(s)
cesarean hysterectomy
Intervention Description
cesarean hysterectomy
Primary Outcome Measure Information:
Title
Amount of blood loss
Time Frame
intraoperative
Title
Amount of Blood transfusion needed in mililiters
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
change of hemoglobin
Time Frame
24 hours
Title
change of hematocrit
Time Frame
24 hours
Title
operative time
Time Frame
intraoperative
Title
incidence of injury of important structures during operation
Description
incidence of injury of important structures during operation as urinary bladder, ureteric, intestinal or great vessels injury
Time Frame
intraoperative
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Placenta previa accreta
Previous 2 cesarean section
completed her family
Hemoglobin > 11 gm/dl
Elective cesarean hysterectomy
Exclusion Criteria:
Anemia ( Hemoglobin < 11 gm/dl)
Not completed her family
BMI > 35 Kg/m2
Bleeding tendency
Emergengy cesarean section
Thrombophilia
Facility Information:
Facility Name
Ain Shams University Maternity Hospital
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Internal Iliac Artery Ligation Before Cesarean Hysterectomy in Morbidly Adherent Placenta
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