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Balloon Catheters in Cases of Abnormal Placentation (Accreta)

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ClinicalTrials.gov Identifier: NCT01373255
Recruitment Status : Completed
First Posted : June 14, 2011
Last Update Posted : June 16, 2015
Sponsor:
Information provided by (Responsible Party):
Raed Salim, HaEmek Medical Center, Israel

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.

Condition or disease Intervention/treatment
Post Partum Bleeding Procedure: internal iliac catheterization

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Balloon Catheter for Occlusion of the Pelvic Vasculature as an Adjuvant Therapy in Cases of Placenta Accreta
Study Start Date : January 2009
Primary Completion Date : April 2015
Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: internal iliac artery catheterization
No Intervention: No intervention
no intervention prior to cesarean



Primary Outcome Measures :
  1. Number of blood products transfused [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Need for hysterectomy [ Time Frame: 5 years ]
  2. catheter`s side effects [ Time Frame: 5 years ]
  3. Length of hospitalization [ Time Frame: 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- women who refuse to participate


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01373255


Locations
Israel
Haemek Medical Center
Afula, Israel
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
Principal Investigator: Raed Salim Dep. OB/GYN, HaEmek Medical Center, Afula, Israel

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Raed Salim, MD, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT01373255     History of Changes
Other Study ID Numbers: 0043-08-EMC
Acreta02 ( Other Identifier: Emek Medical Center )
First Posted: June 14, 2011    Key Record Dates
Last Update Posted: June 16, 2015
Last Verified: June 2015

Keywords provided by Raed Salim, HaEmek Medical Center, Israel:
Placenta accreta
Internal iliac artery catheterization
Post partum bleeding

Additional relevant MeSH terms:
Hemorrhage
Placenta Accreta
Postpartum Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Placenta Diseases
Puerperal Disorders
Uterine Hemorrhage