Internal Iliac Artery Occlusion in Placenta Accreta

NCT04423263 | Unknown

• 1 other identifier: Research ID 55302
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Placenta Accreta

Keywords

balloon occlusion; iliac artery; interventional radiology; postpartum hemorrhage; blood transfusion

Outcome Measures

Primary Outcomes (1)

• Pack cell transfusion

  To detect a three pint reduction in pack cell transfusion

  First 7 days post-operatively

Secondary Outcomes (3)

• Other blood components

  First 7 days post-operatively

• Unplanned perioperative surgical procedures

  First 7 days post-operatively

• Complication from internal iliac occlusion

  First 14 days post-operatively

Other Outcomes (2)

• Operative time

  Perioperative

• Neonatal complication

  First 24 hours

Study Arms (2)

Intervention

EXPERIMENTAL

Receives bilateral internal iliac artery occlusion

Procedure: Bilateral internal iliac artery balloon occlusion

Control

ACTIVE COMPARATOR

Does not receive bilateral internal iliac artery occlusion

Procedure: Control

Interventions

Bilateral internal iliac artery balloon occlusion PROCEDURE

Bilateral internal iliac artery balloon placement under fluoroscopic guidance preoperatively which will be occluded intraoperatively based on existing local protocol

Intervention

Control PROCEDURE

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

Control

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• All pregnant women with prenatally diagnosed placenta accreta spectrum

You may not qualify if:

• 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

Sponsors & Collaborators

• Voon Hian Yan: lead

Related Publications (2)

• Chen M, Liu X, You Y, Wang X, Li T, Luo H, Qu H, Xu L. Internal Iliac Artery Balloon Occlusion for Placenta Previa and Suspected Placenta Accreta: A Randomized Controlled Trial. Obstet Gynecol. 2020 May;135(5):1112-1119. doi: 10.1097/AOG.0000000000003792.

  PMID: 32282608 BACKGROUND

• Salim R, Chulski A, Romano S, Garmi G, Rudin M, Shalev E. Precesarean Prophylactic Balloon Catheters for Suspected Placenta Accreta: A Randomized Controlled Trial. Obstet Gynecol. 2015 Nov;126(5):1022-1028. doi: 10.1097/AOG.0000000000001113.

  PMID: 26444128 BACKGROUND

MeSH Terms

Conditions

Placenta Accreta; Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hian Yan Voon, MRCOG

  Sarawak General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hian Yan Voon, MRCOG

CONTACT

+6082 276666; vhaxyn@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant Maternal Fetal Medicine Specialist

Study Record Dates

• First Submitted: June 5, 2020
• First Posted: June 9, 2020
• Study Start: July 1, 2020
• Primary Completion: July 1, 2023
• Study Completion: December 31, 2023
• Last Updated: June 9, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 36 months from the date of completion of study
• Access Criteria: Written permission to authors and submission of complete protocol