Back to resultsInternal Iliac Artery Ligation and Abnormally Invasive Placenta
Primary Purpose
Placenta Percreta
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
internal iliac artery ligation
Cesarean Hysterectomy
Sponsored by
About this trial
This is an interventional prevention trial for Placenta Percreta
Eligibility Criteria
Inclusion Criteria:
- females with pre-operative diagnosis of abnormally invasive placenta
Exclusion Criteria:
- refusal to get enrolled in the study
Sites / Locations
- Kasr el aini hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Internal Iliac artery ligation group
Hysterectomy only
Arm Description
in this group the patients will undergo bilateral internal iliac artery ligation prior to the hysterectomy procedure
in this group patients will undergo cesarean hysterectomy only
Outcomes
Primary Outcome Measures
amount of intra-operative hemorrhage
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02728232
Brief Title
Internal Iliac Artery Ligation and Abnormally Invasive Placenta
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
April 1, 2017 (Actual)
Study Completion Date
April 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This trial is set to detect the impact of bilateral internal iliac artery ligation on the amount of intra-operative blood loss during the hysterectomy procedure done for the management of abnormally invasive placenta
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Placenta Percreta
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Internal Iliac artery ligation group
Arm Type
Experimental
Arm Description
in this group the patients will undergo bilateral internal iliac artery ligation prior to the hysterectomy procedure
Arm Title
Hysterectomy only
Arm Type
Active Comparator
Arm Description
in this group patients will undergo cesarean hysterectomy only
Intervention Type
Procedure
Intervention Name(s)
internal iliac artery ligation
Intervention Type
Procedure
Intervention Name(s)
Cesarean Hysterectomy
Primary Outcome Measure Information:
Title
amount of intra-operative hemorrhage
Time Frame
2-3 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
females with pre-operative diagnosis of abnormally invasive placenta
Exclusion Criteria:
refusal to get enrolled in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed M Hussein, MD
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasr el aini hospital
City
Cairo
ZIP/Postal Code
12211
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Internal Iliac Artery Ligation and Abnormally Invasive Placenta
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