Internal Iliac Artery Occlusion in Placenta Accreta

Placenta Accreta Clinical Trial

Official title:

Perioperative Prophylactic Bilateral Internal Iliac Artery Occlusion in Placenta Accreta: a Randomized Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04423263
• Other study ID #: Research ID 55302
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2020
• Source: Sarawak General Hospital
• Contact: Hian Yan Voon, MRCOG
• Phone: +6082 276666
• Email: vhaxyn[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: December 31, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Placenta Accreta

Intervention

Procedure:
• 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
• Control
Surgical approach similar to intervention arm, except bilateral internal iliac artery occlusion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Voon Hian Yan

References & 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. — View 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):1022-8. doi: 10.1097/AOG.0000000000001113. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Operative time	Total time taken for procedure	Perioperative
Other	Neonatal complication	Apgar, cord pH, resuscitation, neonatal intensive care admission	First 24 hours
Primary	Pack cell transfusion	To detect a three pint reduction in pack cell transfusion	First 7 days post-operatively
Secondary	Other blood components	Platelets, fresh fozen plasma, cryoprecipitate	First 7 days post-operatively
Secondary	Unplanned perioperative surgical procedures	Internal iliac artery ligation, abdominal packing, relaparotomy	First 7 days post-operatively
Secondary	Complication from internal iliac occlusion	death, arterial thrombosis, aneurysm, hematoma requiring evacuation	First 14 days post-operatively