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

NCT ID: NCT02966197

Last Updated: 2016-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-09-30

Brief Summary

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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

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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.

Conditions

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Placenta Previa Placenta Accreta

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Balloon group

Prophylactic Internal Iliac Artery Balloon Catheterization

Group Type EXPERIMENTAL

prophylactic internal iliac artery balloon catheterization

Intervention Type PROCEDURE

Between June 2015 and August 2016

Prophylactic internal iliac artery balloon

Intervention Type DEVICE

Radiology operation

Intervention Type RADIATION

Control group

no intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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prophylactic internal iliac artery balloon catheterization

Between June 2015 and August 2016

Intervention Type PROCEDURE

Prophylactic internal iliac artery balloon

Intervention Type DEVICE

Radiology operation

Intervention Type RADIATION

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Deng Dongrui

OTHER

Sponsor Role lead

Responsible Party

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Deng Dongrui

professor, chief doctor

Responsibility Role SPONSOR_INVESTIGATOR

Other Identifiers

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TJ-C20150516

Identifier Type: -

Identifier Source: org_study_id