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

Not Applicable

Completed

• Conditions: Placenta Previa; Placenta Accreta
• Interventions: Procedure: prophylactic internal iliac artery balloon catheterization; Device: Prophylactic internal iliac artery balloon; Radiation: Radiology operation

• Registration Number: NCT02966197
• Lead Sponsor: Deng Dongrui

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2015-06
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2016-11
• Study First Submitted: 2016-11-15
• Study First Submitted QC: 2016-11-16
• Last Update Submitted: 2016-11-16
• Study First Posted: 2016-11-17
• Last Update Posted: 2016-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 114

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Balloon group	prophylactic internal iliac artery balloon catheterization	Prophylactic Internal Iliac Artery Balloon Catheterization
Balloon group	Prophylactic internal iliac artery balloon	Prophylactic Internal Iliac Artery Balloon Catheterization
Balloon group	Radiology operation	Prophylactic Internal Iliac Artery Balloon Catheterization

Primary Outcome Measures

Name	Time	Method
blood loss	intraoperative

Secondary Outcome Measures

Name	Time	Method
operation duration	intraoperative
blood transfusion	intraoperative
fluid transfusion	intraoperative