Balloon Catheters in Cases of Abnormal Placentation (Accreta)

June 14, 2015 updated by: Raed Salim, HaEmek Medical Center, Israel

Balloon Catheter for Occlusion of the Pelvic Vasculature as an Adjuvant Therapy in Cases of Placenta Accreta

Placenta accreta is a relatively rare event, in which the placenta is abnormally implanted into the uterine myometrium. The most significant complication is intense bleeding, mainly during labor. The most important risk factors are previous cesarean delivery, placenta previa, and advanced maternal age. Cesarean hysterectomy is the recommended management. During the recent years, inserting intravascular balloon catheter for occlusion and/or arterial embolization, was introduced as an adjuvant therapy in order to minimize blood loss during cesarean hysterectomy or in conduct with conservative management with the intent of avoiding hysterectomy in selective cases. Contradicting reports exist regarding the effectiveness and safety of the catheters in cases of placenta accreta. The objective of this study is to estimate the efficacy of the balloon catheters among women diagnosed with a placenta accreta.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Afula, Israel
        • Haemek Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • pregnant women age 18-45
  • antepartum diagnosis of placenta accreta

Exclusion Criteria:

- women who refuse to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: internal iliac catheterization
Women in this arm will undergo internal iliac artery catheterization prior to the cesarean delivery
Procedure: internal iliac catheterization
Women in this arm will undergo internal iliac artery catheterization prior to the cesarean delivery
Other Names:
  • internal iliac artery catheterization
NO_INTERVENTION: No intervention
no intervention prior to cesarean

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of blood products transfused
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Need for hysterectomy
Time Frame: 5 years
5 years
catheter's side effects
Time Frame: 5 years
5 years
Length of hospitalization
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HaEmek Medical Center, Israel

Investigators

  • Principal Investigator: Raed Salim, Dep. OB/GYN, HaEmek Medical Center, Afula, Israel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (ACTUAL)

April 1, 2015

Study Completion (ACTUAL)

April 1, 2015

Study Registration Dates

First Submitted

June 10, 2011

First Submitted That Met QC Criteria

June 13, 2011

First Posted (ESTIMATE)

June 14, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

June 16, 2015

Last Update Submitted That Met QC Criteria

June 14, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0043-08-EMC
  • Acreta02 (OTHER: Emek Medical Center)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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