Internal Iliac Artery Occlusion in Placenta Accreta

V

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)

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

Trial contacts and locations

0

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Central trial contact

Hian Yan Voon, MRCOG

Data sourced from clinicaltrials.gov

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