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

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ClinicalTrials.gov Identifier: NCT02966197
Recruitment Status : Completed
First Posted : November 17, 2016
Last Update Posted : November 17, 2016
Sponsor:
Information provided by (Responsible Party):
Deng Dongrui, Tongji Hospital

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.

Condition or disease Intervention/treatment Phase
Placenta Previa Placenta Accreta Procedure: prophylactic internal iliac artery balloon catheterization Device: Prophylactic internal iliac artery balloon Radiation: Radiology operation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: the Efficacy of Prophylactic Internal Iliac Artery Balloon Catheterization in the Management of Placenta Previa and Accreta
Study Start Date : June 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Balloon group
Prophylactic Internal Iliac Artery Balloon Catheterization
Procedure: prophylactic internal iliac artery balloon catheterization
Between June 2015 and August 2016

Device: Prophylactic internal iliac artery balloon
Radiation: Radiology operation
No Intervention: Control group
no intervention



Primary Outcome Measures :
  1. blood loss [ Time Frame: intraoperative ]

Secondary Outcome Measures :
  1. operation duration [ Time Frame: intraoperative ]
  2. fluid transfusion [ Time Frame: intraoperative ]
  3. blood transfusion [ Time Frame: intraoperative ]


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

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Responsible Party: Deng Dongrui, professor, chief doctor, Tongji Hospital
ClinicalTrials.gov Identifier: NCT02966197     History of Changes
Other Study ID Numbers: TJ-C20150516
First Posted: November 17, 2016    Key Record Dates
Last Update Posted: November 17, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Placenta Previa
Placenta Accreta
Obstetric Labor Complications
Pregnancy Complications
Placenta Diseases