Internal Iliac Artery Occlusion in Placenta Accreta

Perioperative Prophylactic Bilateral Internal Iliac Artery Occlusion in Placenta Accreta: a Randomized Trial

This is a randomized study to assess the efficacy of prophylactic bilateral internal iliac artery occlusion performed prior to planned surgical management for placenta accreta spectrum (PAS). The intervention group would receive balloon occlusion, ureteric stenting and caesaeran hysterectomy while the control group would undergo the same procedure, excluding balloon occlusion. The primary outcome is to demonstrate a three pint or greater reduction in pack cell transfusion requirement.

Study Overview

• Status: Not yet recruiting
• Conditions: Placenta Accreta
• Intervention / Treatment: Procedure: Bilateral internal iliac artery balloon occlusion; Procedure: Control

Detailed Description

Interventional radiology, including internal iliac artery occlusion, has been used as an adjunct in the management of placenta accreta spectrum (PAS). Retrospective studies have shown benefit in terms of reduction of blood loss. However, studies reported in literature vary widely in terms of the exact surgical procedure undertaken, in conjunction with the radiological intervention. The radiological intervention itself lacks standardization, occurring at different anatomical levels, ranging from infrarenal aortic occlusion to internal iliac or uterine artery. Furthermore, there have been reported cases of arterial thrombosis associated with arterial occlusion.

We sought to clarify the effectiveness of a standardized approach , where perioperative bilateral internal iliac artery occlusion is performed followed by bilateral ureteric stenting and caesarean hysterectomy. The control group would undergo the exact procedure, excluding internal iliac artery occlusion. Patients would be randomized but neither the patient nor surgeon could be blinded.

The primary outcome would be to demonstrate a three pint or greater reduction in packed cell transfusion. Secondary outcomes include a difference in estimated blood loss, additional blood product transfusion, unplanned additional surgical procedure, serious complications arising from internal iliac artery occlusion, total procedural time and early neonatal outcome.

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hian Yan Voon, MRCOG; Phone Number: +6082 276666; Email: vhaxyn@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• All pregnant women with prenatally diagnosed placenta accreta spectrum

Exclusion Criteria:

• Women who declined to participate
• Women with bleeding diathesis or severe thrombocytopenia <100k x 1,000,000/L
• Surgery performed prior to 28 weeks of gestation

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
Experimental: Intervention; Receives bilateral internal iliac artery occlusion	Procedure: Bilateral internal iliac artery balloon occlusion; Bilateral internal iliac artery balloon placement under fluoroscopic guidance preoperatively which will be occluded intraoperatively based on existing local protocol
Active Comparator: Control; Does not receive bilateral internal iliac artery occlusion	Procedure: Control; Surgical approach similar to intervention arm, except bilateral internal iliac artery occlusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pack cell transfusion	To detect a three pint reduction in pack cell transfusion	First 7 days post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Other blood components	Platelets, fresh fozen plasma, cryoprecipitate	First 7 days post-operatively
Unplanned perioperative surgical procedures	Internal iliac artery ligation, abdominal packing, relaparotomy	First 7 days post-operatively
Complication from internal iliac occlusion	death, arterial thrombosis, aneurysm, hematoma requiring evacuation	First 14 days post-operatively

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative time	Total time taken for procedure	Perioperative
Neonatal complication	Apgar, cord pH, resuscitation, neonatal intensive care admission	First 24 hours

Collaborators and Investigators

• Sponsor: Voon Hian Yan

Publications and helpful links

General Publications

• Chen M, Liu X, You Y, Wang X, Li T, Luo H, Qu H, Xu L. Internal Iliac Artery Balloon Occlusion for Placenta Previa and Suspected Placenta Accreta: A Randomized Controlled Trial. Obstet Gynecol. 2020 May;135(5):1112-1119. doi: 10.1097/AOG.0000000000003792.
• Salim R, Chulski A, Romano S, Garmi G, Rudin M, Shalev E. Precesarean Prophylactic Balloon Catheters for Suspected Placenta Accreta: A Randomized Controlled Trial. Obstet Gynecol. 2015 Nov;126(5):1022-1028. doi: 10.1097/AOG.0000000000001113.

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2020
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: June 5, 2020
• First Submitted That Met QC Criteria: June 5, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Actual): June 9, 2020
• Last Update Submitted That Met QC Criteria: June 5, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: blood transfusion; postpartum hemorrhage; interventional radiology; balloon occlusion; iliac artery
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Placenta Diseases; Placenta Accreta
• Other Study ID Numbers: Research ID 55302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Study protocol and anonymized information including demographics, primary and secondary outcomes
• IPD Sharing Time Frame: 36 months from the date of completion of study
• IPD Sharing Access Criteria: Written permission to authors and submission of complete protocol
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes