Bilateral Internal Iliac Artery Ligation Before Cesarean Hysterectomy

NCT03129035 | Unknown DMC

• 1 other identifier: 4
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Placenta Accreta

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

internal iliac artery ligation

ACTIVE COMPARATOR

women undergo bilateral internal iliac artery ligation after fetal extraction and before proceeding in cesarean hysterectomy

Procedure: Cesarean hystrectomy; Procedure: Internal iliac artery ligation

No internal iliac artery ligation

ACTIVE COMPARATOR

Women undergo cesarean hysterectomy after fetal extraction

Procedure: Cesarean hystrectomy

Interventions

Cesarean hystrectomy PROCEDURE

Upper segment cesarean section followed by fetal extraction and cesarean hystrectomy started without any attempts of placental removal

No internal iliac artery ligation; internal iliac artery ligation

Internal iliac artery ligation PROCEDURE

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 The ureter was retracted medially by gentle finger dissection, revealing the retroperitoneal anatomy.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

internal iliac artery ligation

Eligibility Criteria

• Age: 20 Years - 44 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy medical school

Cairo, 12151, Egypt

Location

MeSH Terms

Conditions

Placenta Accreta

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases

Study Officials

• Ahmed Maged, MD

  Kasr Alainy medical school

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Maged, MD

CONTACT

01005227404; prof.ahmedmaged@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 20, 2017
• First Posted: April 26, 2017
• Study Start: May 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: February 1, 2018
• Last Updated: April 26, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)