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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Receives bilateral internal iliac artery occlusion |
|
| Control | Active Comparator | Does not receive bilateral internal iliac artery occlusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pack cell transfusion | To detect a three pint reduction in pack cell transfusion | First 7 days post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Other blood components | Platelets, fresh fozen plasma, cryoprecipitate | First 7 days post-operatively |
| Unplanned perioperative surgical procedures | Internal iliac artery ligation, abdominal packing, relaparotomy |
| Measure | Description | Time Frame |
|---|---|---|
| Operative time | Total time taken for procedure | Perioperative |
| Neonatal complication | Apgar, cord pH, resuscitation, neonatal intensive care admission |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hian Yan Voon, MRCOG | Contact | +6082 276666 | vhaxyn@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hian Yan Voon, MRCOG | Sarawak General Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32282608 | Background | 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. | |
| 26444128 | 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. |
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Study protocol and anonymized information including demographics, primary and secondary outcomes
36 months from the date of completion of study
Written permission to authors and submission of complete protocol
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| ID | Term |
|---|---|
| D010921 | Placenta Accreta |
| D006473 | Postpartum Hemorrhage |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| Control | Procedure | Surgical approach similar to intervention arm, except bilateral internal iliac artery occlusion |
|
| First 7 days post-operatively |
| Complication from internal iliac occlusion | death, arterial thrombosis, aneurysm, hematoma requiring evacuation | First 14 days post-operatively |
| First 24 hours |
| D010922 | Placenta Diseases |
| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |