Internal Iliac Artery Occlusion in Placenta Accreta

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Placenta Accreta

Intervention / Treatment
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* Procedure: Bilateral internal iliac artery balloon occlusion
* Procedure: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Receives bilateral internal iliac artery occlusion | Procedure: Bilateral internal iliac artery balloon occlusion<br>* Bilateral internal iliac artery balloon placement under fluoroscopic guidance preoperatively which will be occluded intraoperatively based on existing local protocol<br>|
| Active Comparator: Control<br>Does not receive bilateral internal iliac artery occlusion | Procedure: Control<br>* Surgical approach similar to intervention arm, except bilateral internal iliac artery occlusion<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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balloon occlusion, iliac artery, interventional radiology, postpartum hemorrhage, blood transfusion