Back to resultsBalloon Catheters in Cases of Abnormal Placentation (Accreta)
Primary Purpose
Post Partum Bleeding
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
internal iliac catheterization
Sponsored by
About this trial
This is an interventional prevention trial for Post Partum Bleeding focused on measuring Placenta accreta, Internal iliac artery catheterization, Post partum bleeding
Eligibility Criteria
Inclusion Criteria:
- pregnant women age 18-45
- antepartum diagnosis of placenta accreta
Exclusion Criteria:
- women who refuse to participate
Sites / Locations
- Haemek Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
internal iliac catheterization
No intervention
Arm Description
Women in this arm will undergo internal iliac artery catheterization prior to the cesarean delivery
no intervention prior to cesarean
Outcomes
Primary Outcome Measures
Number of blood products transfused
Secondary Outcome Measures
Need for hysterectomy
catheter's side effects
Length of hospitalization
Full Information
NCT ID
NCT01373255
First Posted
June 10, 2011
Last Updated
June 14, 2015
Sponsor
HaEmek Medical Center, Israel
1. Study Identification
Unique Protocol Identification Number
NCT01373255
Brief Title
Balloon Catheters in Cases of Abnormal Placentation
Acronym
Accreta
Official Title
Balloon Catheter for Occlusion of the Pelvic Vasculature as an Adjuvant Therapy in Cases of Placenta Accreta
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
HaEmek Medical Center, Israel
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Partum Bleeding
Keywords
Placenta accreta, Internal iliac artery catheterization, Post partum bleeding
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
internal iliac catheterization
Arm Type
Experimental
Arm Description
Women in this arm will undergo internal iliac artery catheterization prior to the cesarean delivery
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
no intervention prior to cesarean
Intervention Type
Procedure
Intervention Name(s)
internal iliac catheterization
Other Intervention Name(s)
internal iliac artery catheterization
Intervention Description
Women in this arm will undergo internal iliac artery catheterization prior to the cesarean delivery
Primary Outcome Measure Information:
Title
Number of blood products transfused
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Need for hysterectomy
Time Frame
5 years
Title
catheter's side effects
Time Frame
5 years
Title
Length of hospitalization
Time Frame
5 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
pregnant women age 18-45
antepartum diagnosis of placenta accreta
Exclusion Criteria:
- women who refuse to participate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raed Salim
Organizational Affiliation
Dep. OB/GYN, HaEmek Medical Center, Afula, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haemek Medical Center
City
Afula
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
26444128
Citation
Salim R, Chulski A, Romano S, Garmi G, Rudin M, Shalev E. Precesarean Prophylactic Balloon Catheters for Suspected Placenta Accreta: A Randomized Controlled Trial. Obstet Gynecol. 2015 Nov;126(5):1022-1028. doi: 10.1097/AOG.0000000000001113.
Results Reference
derived
Learn more about this trial
Balloon Catheters in Cases of Abnormal Placentation
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