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Bilateral Internal Iliac Artery Ligation Before Cesarean Hysterectomy

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ClinicalTrials.gov Identifier: NCT03129035
Recruitment Status : Unknown
Verified April 2017 by Ahmed Maged, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : April 26, 2017
Last Update Posted : April 26, 2017
Sponsor:
Information provided by (Responsible Party):
Ahmed Maged, Cairo University

Brief Summary:

All women with placenta accreta will be managed by upper segment cesarean section followed by cesarean hysterectomy without attempts of placental removal.

Women were randomized to either bilateral internal iliac artery ligation before hysterectomy and after fetal extraction or no additional intervention


Condition or disease Intervention/treatment Phase
Placenta Accreta Procedure: Cesarean hystrectomy Procedure: Internal iliac artery ligation Not Applicable

Detailed Description:

All women with placenta accreta will be managed by upper segment cesarean section followed by cesarean hysterectomy without attempts of placental removal.

Women were randomized to either bilateral internal iliac artery ligation before hysterectomy and after fetal extraction or no additional intervention.

Midline incision in the all patients is preferred. The retroperitoneal space was entered at the level of common iliac bifurcation and followed to the point of division into the external and internal iliac arteries. The ureter was retracted medially by gentle finger dissection, revealing the retroperitoneal anatomy. The fat and loose connective tissue around the IIA and vein were removed and a right-angle clamp was passed beneath the IIA from the lateral to the medial side approximately 4 cm distal to its origin.

Using an absorbable suture, the IIA was ligated doubly in all cases . Pulsations of the external iliac and femoral arteries were identified after internal iliac ligation. The procedure was then repeated on the other side.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bilateral Internal Iliac Artery Ligation Before Cesarean Hysterectomy : A Randomized Controlled Trial
Estimated Study Start Date : May 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy

Arm Intervention/treatment
Active Comparator: internal iliac artery ligation
women undergo bilateral internal iliac artery ligation after fetal extraction and before proceeding in cesarean hysterectomy
Procedure: Cesarean hystrectomy
Upper segment cesarean section followed by fetal extraction and cesarean hystrectomy started without any attempts of placental removal

Procedure: Internal iliac artery ligation
The retroperitoneal space was entered at the level of common iliac bifurcation and followed to the point of division into the external and internal iliac arteries. The ureter was retracted medially by gentle finger dissection, revealing the retroperitoneal anatomy. The fat and loose connective tissue around the IIA and vein were removed and a right-angle clamp was passed beneath the IIA from the lateral to the medial side approximately 4 cm distal to its origin. Using an absorbable suture, the IIA was ligated doubly in all cases . Pulsations of the external iliac and femoral arteries were identified after internal iliac ligation. The procedure was then repeated on the other side

Active Comparator: No internal iliac artery ligation
Women undergo cesarean hysterectomy after fetal extraction
Procedure: Cesarean hystrectomy
Upper segment cesarean section followed by fetal extraction and cesarean hystrectomy started without any attempts of placental removal




Primary Outcome Measures :
  1. Number of participants needed blood transfusion [ Time Frame: within 24 hours from surgery ]
    number of cases in each group who needed blood transfusion whether intraoperative or within 24 hours postoperative



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Ages Eligible for Study:   20 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • women with suspected placenta accreta
  • Scarred uterus
  • Approving hysterectomy

Exclusion Criteria:

  • Women needed conservative surgery
  • women with coagulopathy or bleeding disorders

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): NCT03129035


Contacts
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Contact: Ahmed Maged, MD 01005227404 prof.ahmedmaged@gmail.com

Locations
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Egypt
Kasr Alainy medical school
Cairo, Egypt, 12151
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Ahmed Maged, MD Kasr Alainy medical school

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Responsible Party: Ahmed Maged, Professor, Cairo University
ClinicalTrials.gov Identifier: NCT03129035     History of Changes
Other Study ID Numbers: 4
First Posted: April 26, 2017    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Placenta Accreta
Obstetric Labor Complications
Pregnancy Complications
Placenta Diseases