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Internal Iliac Artery Ligation Before Cesarean Hysterectomy in Morbidly Adherent 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: NCT03824873
Recruitment Status : Completed
First Posted : January 31, 2019
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Mohamed S Sweed, MD, Ain Shams University

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.

Condition or disease Intervention/treatment Phase
Blood Loss Procedure: Internal iliac artery ligation Procedure: cesarean hysterectomy Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Internal Iliac Artery Ligation Before Cesarean Hysterectomy in Morbidly Adherent Placenta: A Randomized Clinical Trial
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : October 1, 2018
Actual Study Completion Date : October 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy

Arm Intervention/treatment
Active Comparator: internal iliac artery ligation + cesarean hysterectomy Procedure: Internal iliac artery ligation
Internal iliac artery ligation and cesarean hysterectomy
Other Name: cesarean hysterectomy

Procedure: cesarean hysterectomy
cesarean hysterectomy

Active Comparator: cesarean hysterectomy Procedure: cesarean hysterectomy
cesarean hysterectomy




Primary Outcome Measures :
  1. Amount of blood loss [ Time Frame: intraoperative ]
  2. Amount of Blood transfusion needed in mililiters [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. change of hemoglobin [ Time Frame: 24 hours ]
  2. change of hematocrit [ Time Frame: 24 hours ]
  3. operative time [ Time Frame: intraoperative ]
  4. incidence of injury of important structures during operation [ Time Frame: intraoperative ]
    incidence of injury of important structures during operation as urinary bladder, ureteric, intestinal or great vessels injury



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Ages Eligible for Study:   25 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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): NCT03824873


Locations
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Egypt
Ain Shams University Maternity Hospital
Cairo, Egypt
Sponsors and Collaborators
Ain Shams University

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Responsible Party: Mohamed S Sweed, MD, Principal Investigator, Ain Shams University
ClinicalTrials.gov Identifier: NCT03824873     History of Changes
Other Study ID Numbers: AS1862
First Posted: January 31, 2019    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mohamed S Sweed, MD, Ain Shams University:
Internal iliac artery
Internal iliac artery ligation
Placenta previa
Placenta accreta
cesarean hysterectomy
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes