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Internal Iliac Artery Ligation and Abnormally Invasive Placenta

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02728232
Recruitment Status : Completed
First Posted : April 5, 2016
Last Update Posted : April 18, 2017
Sponsor:
Information provided by (Responsible Party):
Ahmed Mahmoud Hussein, Cairo University

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

Condition or disease Intervention/treatment Phase
Placenta Percreta Procedure: internal iliac artery ligation Procedure: Cesarean Hysterectomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Actual Study Start Date : April 2016
Actual Primary Completion Date : April 1, 2017
Actual Study Completion Date : April 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy

Arm Intervention/treatment
Experimental: Internal Iliac artery ligation group
in this group the patients will undergo bilateral internal iliac artery ligation prior to the hysterectomy procedure
Procedure: internal iliac artery ligation
Procedure: Cesarean Hysterectomy
Active Comparator: Hysterectomy only
in this group patients will undergo cesarean hysterectomy only
Procedure: Cesarean Hysterectomy



Primary Outcome Measures :
  1. amount of intra-operative hemorrhage [ Time Frame: 2-3 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • females with pre-operative diagnosis of abnormally invasive placenta

Exclusion Criteria:

  • refusal to get enrolled in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02728232


Locations
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Egypt
Kasr el aini hospital
Cairo, Egypt, 12211
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Ahmed M Hussein, MD Cairo University
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Responsible Party: Ahmed Mahmoud Hussein, Lecturer of Obstetrics and Gynecology, Cairo University
ClinicalTrials.gov Identifier: NCT02728232    
Other Study ID Numbers: PP2302019
First Posted: April 5, 2016    Key Record Dates
Last Update Posted: April 18, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Placenta Accreta
Obstetric Labor Complications
Pregnancy Complications
Placenta Diseases