Bilateral Internal Iliac Artery Ligation Before Cesarean Hysterectomy

• ClinicalTrials.gov Identifier: NCT03129035
• Recruitment Status: Unknown
• First Posted: April 26, 2017
• Last Update Posted: April 26, 2017
• Sponsor: Cairo University
• Information provided by (Responsible Party): Ahmed Maged, Cairo University

Study Description

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 The ureter was retracted medially by gentle finger dissection, revealing the retroperitoneal anatomy.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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Contacts

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

Locations

Egypt

Kasr Alainy medical school

Cairo, Egypt, 12151

Sponsors and Collaborators

Cairo University

Investigators

• Principal Investigator: Ahmed Maged, MD; Kasr Alainy medical school

More Information

• Responsible Party: Ahmed Maged, Professor, Cairo University
• ClinicalTrials.gov Identifier: NCT03129035
• Other Study ID Numbers: 4
• First Posted: April 26, 2017
• Last Update Posted: April 26, 2017
• Last Verified: April 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Placenta Accreta; Obstetric Labor Complications; Pregnancy Complications; Placenta Diseases