Placenta Accreta
Conditions
Keywords
balloon occlusion, iliac artery, interventional radiology, postpartum hemorrhage, blood transfusion
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.
Interventions
Bilateral internal iliac artery balloon placement under fluoroscopic guidance preoperatively which will be occluded intraoperatively based on existing local protocol
PROCEDUREControl
Surgical approach similar to intervention arm, except bilateral internal iliac artery occlusion
Sponsors
Voon Hian Yan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pack cell transfusion | First 7 days post-operatively | To detect a three pint reduction in pack cell transfusion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Other blood components | First 7 days post-operatively | Platelets, fresh fozen plasma, cryoprecipitate |
| Unplanned perioperative surgical procedures | First 7 days post-operatively | Internal iliac artery ligation, abdominal packing, relaparotomy |
| Complication from internal iliac occlusion | First 14 days post-operatively | death, arterial thrombosis, aneurysm, hematoma requiring evacuation |
Other
| Measure | Time frame | Description |
|---|---|---|
| Operative time | Perioperative | Total time taken for procedure |
| Neonatal complication | First 24 hours | Apgar, cord pH, resuscitation, neonatal intensive care admission |
Contacts
Primary ContactHian Yan Voon, MRCOG
Outcome results
None listed