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Internal Iliac Artery Occlusion in Placenta Accreta

NCT04423263 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2020-06-09

No results posted yet for this study

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.

Conditions

  • Placenta Accreta

Interventions

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

PROCEDURE

Control

Surgical approach similar to intervention arm, except bilateral internal iliac artery occlusion

Sponsors & Collaborators

  • Voon Hian Yan

    lead OTHER

Principal Investigators

  • Hian Yan Voon, MRCOG · Sarawak General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2023-07-01
Completion
2023-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04423263 on ClinicalTrials.gov