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OpenTrials
Completed

NCT Number: NCT02966197

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

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.

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Key information

Age range

15 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

prophylactic internal iliac artery balloon catheterization

Procedure

Between June 2015 and August 2016

Prophylactic internal iliac artery balloon

Device

Radiology operation

Radiation

Primary outcomes

  1. blood loss

    Time frame: intraoperative

Secondary outcomes

  1. operation duration

    Time frame: intraoperative

  2. fluid transfusion

    Time frame: intraoperative

  3. blood transfusion

    Time frame: intraoperative

Sponsors and collaborators

Lead sponsor

Deng Dongrui

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 17, 2016
Registry last updated
Nov 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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