Internal Iliac Artery Occlusion in Placenta Accreta

Voon Hian Yan

Status: Not yet enrolling

Conditions: Placenta Accreta

Treatments: Procedure: Control; Procedure: Bilateral internal iliac artery balloon occlusion

Study type: Interventional

Funder types: Other

Identifiers

NCT04423263

Research ID 55302

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Intervention

Experimental group

Description:

Receives bilateral internal iliac artery occlusion

Treatment:

Procedure: Bilateral internal iliac artery balloon occlusion

Control

Active Comparator group

Description:

Does not receive bilateral internal iliac artery occlusion

Treatment:

Procedure: Control