Clinical trial NCT04423263: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Placenta Accreta
Keywords: balloon occlusion
iliac artery
interventional radiology
postpartum hemorrhage
blood transfusion
Lead sponsor: Sarawak General Hospital
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pack cell transfusion
timeFrame: First 7 days post-operatively
Secondary outcomes:
measure: Other blood components
timeFrame: First 7 days post-operatively
measure: Unplanned perioperative surgical procedures
timeFrame: First 7 days post-operatively
measure: Complication from internal iliac occlusion
timeFrame: First 14 days post-operatively
Other outcomes:
measure: Operative time
timeFrame: Perioperative
measure: Neonatal complication
timeFrame: First 24 hours
Locations:
Study officials:
affiliation: Sarawak General Hospital
name: Hian Yan Voon, MRCOG
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.