Internal Iliac Artery Occlusion in Placenta Accreta

Not Applicable

• Conditions: Placenta Accreta
• Interventions: Procedure: Bilateral internal iliac artery balloon occlusion; Procedure: Control

• Registration Number: NCT04423263
• Lead Sponsor: Voon Hian Yan

Brief Summary

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.

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 Timeline

• Status Verified: 2020-06
• Study First Submitted: 2020-06-05
• Study First Submitted QC: 2020-06-05
• Last Update Submitted: 2020-06-05
• Study First Posted: 2020-06-09
• Last Update Posted: 2020-06-09
• Study Start: 2020-07-01
• Primary Completion: 2023-07-01
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Bilateral internal iliac artery balloon occlusion	Receives bilateral internal iliac artery occlusion
Control	Control	Does not receive bilateral internal iliac artery occlusion

Primary Outcome Measures

Name	Time	Method
Pack cell transfusion	First 7 days post-operatively	To detect a three pint reduction in pack cell transfusion

Secondary Outcome Measures

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