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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

Tracking Information
First Submitted Date  ICMJE January 26, 2019
First Posted Date  ICMJE January 31, 2019
Last Update Posted Date January 31, 2019
Actual Study Start Date  ICMJE March 1, 2017
Actual Primary Completion Date October 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2019)
  • Amount of blood loss [ Time Frame: intraoperative ]
  • Amount of Blood transfusion needed in mililiters [ Time Frame: 24 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2019)
  • change of hemoglobin [ Time Frame: 24 hours ]
  • change of hematocrit [ Time Frame: 24 hours ]
  • operative time [ Time Frame: intraoperative ]
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Internal Iliac Artery Ligation Before Cesarean Hysterectomy in Morbidly Adherent Placenta
Official Title  ICMJE Internal Iliac Artery Ligation Before Cesarean Hysterectomy in Morbidly Adherent Placenta: A Randomized Clinical Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Blood Loss
Intervention  ICMJE
  • Procedure: Internal iliac artery ligation
    Internal iliac artery ligation and cesarean hysterectomy
    Other Name: cesarean hysterectomy
  • Procedure: cesarean hysterectomy
    cesarean hysterectomy
Study Arms  ICMJE
  • Active Comparator: internal iliac artery ligation + cesarean hysterectomy
    Interventions:
    • Procedure: Internal iliac artery ligation
    • Procedure: cesarean hysterectomy
  • Active Comparator: cesarean hysterectomy
    Intervention: Procedure: cesarean hysterectomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 30, 2019)
40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 1, 2018
Actual Primary Completion Date October 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 25 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03824873
Other Study ID Numbers  ICMJE AS1862
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mohamed S Sweed, MD, Ain Shams University
Study Sponsor  ICMJE Ain Shams University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ain Shams University
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP