Efficacy of Prophylactic Internal Iliac Artery Balloon Catheterization in the Management of Placenta Previa and Accreta

Deng Dongrui

Status: Completed

Conditions: Placenta Accreta; Placenta Previa

Treatments: Radiation: Radiology operation; Device: Prophylactic internal iliac artery balloon; Procedure: prophylactic internal iliac artery balloon catheterization

Study type: Interventional

Funder types: Other

Identifiers

NCT02966197

TJ-C20150516

Details and patient eligibility

About

Placenta previa and accreta both could potentially cause serious postpartum hemorrhage and even maternal death. Interventional radiological techniques have been developed to limit massive hemorrhage during caesarean section. This study investigated the efficacy of prophylactic internal iliac artery balloon catheterization in management for placenta previa and accreta.

Full description

Placenta previa and accreta both could potentially cause serious postpartum hemorrhage and even maternal death. Interventional radiological techniques have been developed to limit massive hemorrhage during caesarean section. This study investigated the efficacy of prophylactic internal iliac artery balloon catheterization in management for placenta previa and accreta. Between June 2015 and August 2016,patients were personally recruited and managed by the authors,and assigned to either balloon group or control group by their willingness to catheterization or not. Both groups benefitted similar management protocol with the exception of interventional radiology operation. Intraoperative blood loss, transfusion volume, radiation dose, exposure time, surgical duration, procedure complications and neonatal outcomes were analyzed.

Enrollment: 114 patients

Sex: Female

Ages: 15 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pregnant women were eligible if they were diagnosed to have placenta previa and accreta by sonographic examination or Magnetic Resonance Imaging.

Exclusion criteria

• Any case who had bleeding disorder or underwent emergency cesarean delivery was excluded.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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114 participants in 2 patient groups

Balloon group

Experimental group

Description:

Prophylactic Internal Iliac Artery Balloon Catheterization

Treatment:

Radiation: Radiology operation

Device: Prophylactic internal iliac artery balloon

Procedure: prophylactic internal iliac artery balloon catheterization

Control group

No Intervention group

Description:

no intervention