Internal Iliac Artery Occlusion in Placenta Accreta

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Bilateral Internal Iliac Artery Ligation Before Cesarean Hysterectomy

NCT03129035

Placenta Accreta

UNKNOWN NA

Internal Iliac Artery Ligation Before Cesarean Hysterectomy in Morbidly Adherent Placenta

NCT03824873

Blood Loss

COMPLETED PHASE3

Conservative Treatment of PAS With or Without IIL

NCT05232981

Placenta Accreta Cesarean Hysterectomy Pelvic Devascularization

RECRUITING NA

Prevention of Fascial Dehiscence With Prophylactic Onlay Mesh in Emergency Laparotomies

NCT03293862

Surgical Wound Dehiscence

COMPLETED NA

Cystoinflation to Prevent Bladder Injury in Obstetrics and Gynaecology Surgery

NCT04302545

Bladder Injury Complications; Cesarean Section Adhesions Pelvic

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Placenta Accreta

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention

Receives bilateral internal iliac artery occlusion

Group Type EXPERIMENTAL

Bilateral internal iliac artery balloon occlusion

Intervention Type PROCEDURE

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

Control

Does not receive bilateral internal iliac artery occlusion

Group Type ACTIVE_COMPARATOR

Control

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type PROCEDURE

Control

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes