Internal Iliac Artery Occlusion in Placenta Accreta
Primary Purpose
Placenta Accreta
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bilateral internal iliac artery balloon occlusion
Control
Sponsored by
About this trial
This is an interventional treatment trial for Placenta Accreta focused on measuring balloon occlusion, iliac artery, interventional radiology, postpartum hemorrhage, blood transfusion
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention
Control
Arm Description
Receives bilateral internal iliac artery occlusion
Does not receive bilateral internal iliac artery occlusion
Outcomes
Primary Outcome Measures
Pack cell transfusion
To detect a three pint reduction in pack cell transfusion
Secondary Outcome Measures
Other blood components
Platelets, fresh fozen plasma, cryoprecipitate
Unplanned perioperative surgical procedures
Internal iliac artery ligation, abdominal packing, relaparotomy
Complication from internal iliac occlusion
death, arterial thrombosis, aneurysm, hematoma requiring evacuation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04423263
Brief Title
Internal Iliac Artery Occlusion in Placenta Accreta
Official Title
Perioperative Prophylactic Bilateral Internal Iliac Artery Occlusion in Placenta Accreta: a Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2020 (Anticipated)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Voon Hian Yan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Placenta Accreta
Keywords
balloon occlusion, iliac artery, interventional radiology, postpartum hemorrhage, blood transfusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Receives bilateral internal iliac artery occlusion
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Does not receive bilateral internal iliac artery occlusion
Intervention Type
Procedure
Intervention Name(s)
Bilateral internal iliac artery balloon occlusion
Intervention Description
Bilateral internal iliac artery balloon placement under fluoroscopic guidance preoperatively which will be occluded intraoperatively based on existing local protocol
Intervention Type
Procedure
Intervention Name(s)
Control
Intervention Description
Surgical approach similar to intervention arm, except bilateral internal iliac artery occlusion
Primary Outcome Measure Information:
Title
Pack cell transfusion
Description
To detect a three pint reduction in pack cell transfusion
Time Frame
First 7 days post-operatively
Secondary Outcome Measure Information:
Title
Other blood components
Description
Platelets, fresh fozen plasma, cryoprecipitate
Time Frame
First 7 days post-operatively
Title
Unplanned perioperative surgical procedures
Description
Internal iliac artery ligation, abdominal packing, relaparotomy
Time Frame
First 7 days post-operatively
Title
Complication from internal iliac occlusion
Description
death, arterial thrombosis, aneurysm, hematoma requiring evacuation
Time Frame
First 14 days post-operatively
Other Pre-specified Outcome Measures:
Title
Operative time
Description
Total time taken for procedure
Time Frame
Perioperative
Title
Neonatal complication
Description
Apgar, cord pH, resuscitation, neonatal intensive care admission
Time Frame
First 24 hours
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hian Yan Voon, MRCOG
Phone
+6082 276666
Email
vhaxyn@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hian Yan Voon, MRCOG
Organizational Affiliation
Sarawak General Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Study protocol and anonymized information including demographics, primary and secondary outcomes
IPD Sharing Time Frame
36 months from the date of completion of study
IPD Sharing Access Criteria
Written permission to authors and submission of complete protocol
Citations:
PubMed Identifier
32282608
Citation
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.
Results Reference
background
PubMed Identifier
26444128
Citation
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.
Results Reference
background
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Internal Iliac Artery Occlusion in Placenta Accreta
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