Bilateral Internal Iliac Artery Ligation Before Cesarean Hysterectomy

Bilateral Internal Iliac Artery Ligation Before Cesarean Hysterectomy : A Randomized Controlled Trial

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

Study Overview

• Status: Unknown
• Conditions: Placenta Accreta
• Intervention / Treatment: Procedure: Cesarean hystrectomy; Procedure: Internal iliac artery ligation

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 The ureter was retracted medially by gentle finger dissection, revealing the retroperitoneal anatomy.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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 12151
    • Kasr Alainy medical school

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 44 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants needed blood transfusion	number of cases in each group who needed blood transfusion whether intraoperative or within 24 hours postoperative	within 24 hours from surgery

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2017
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): February 1, 2018

Study Registration Dates

• First Submitted: April 20, 2017
• First Submitted That Met QC Criteria: April 25, 2017
• First Posted (Actual): April 26, 2017

Study Record Updates

• Last Update Posted (Actual): April 26, 2017
• Last Update Submitted That Met QC Criteria: April 25, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Placenta Diseases; Placenta Accreta
• Other Study ID Numbers: 4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No