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

Placenta Accreta Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02966197
• Other study ID #: TJ-C20150516
• Status: Completed
• Phase: N/A
• First received: November 15, 2016
• Last updated: November 16, 2016
• Start date: June 2015
• Est. completion date: September 2016

Study information

• Verified date: November 2016
• Source: Tongji Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 60 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Placenta Accreta
• Placenta Previa

Intervention

Procedure:
• prophylactic internal iliac artery balloon catheterization
Between June 2015 and August 2016

Device:
• Prophylactic internal iliac artery balloon

Radiation:
• Radiology operation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Deng Dongrui

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood loss		intraoperative	No
Secondary	operation duration		intraoperative	No
Secondary	fluid transfusion		intraoperative	No
Secondary	blood transfusion		intraoperative	No