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

Study Overview
=================
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.

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

Conditions
-----------------
Placenta Previa, Placenta Accreta

Intervention / Treatment
-----------------
* Procedure: prophylactic internal iliac artery balloon catheterization
* Device: Prophylactic internal iliac artery balloon
* Radiation: Radiology operation


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Balloon group<br>Prophylactic Internal Iliac Artery Balloon Catheterization | Procedure: prophylactic internal iliac artery balloon catheterization<br>* Between June 2015 and August 2016<br>Device: Prophylactic internal iliac artery balloon<br> <br> Radiation: Radiology operation<br> <br> |
| No Intervention: Control group<br>no intervention | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood loss |  | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operation duration |  | intraoperative | 
| fluid transfusion |  | intraoperative | 
| blood transfusion |  | intraoperative |