Balloon Catheters in Cases of Abnormal Placentation (Accreta)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by HaEmek Medical Center, Israel
Sponsor:
Information provided by (Responsible Party):
Raed Salim, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT01373255
First received: June 10, 2011
Last updated: April 8, 2014
Last verified: March 2013
  Purpose

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 Intervention
Post Partum Bleeding
Procedure: internal iliac catheterization

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Balloon Catheter for Occlusion of the Pelvic Vasculature as an Adjuvant Therapy in Cases of Placenta Accreta

Resource links provided by NLM:


Further study details as provided by HaEmek Medical Center, Israel:

Primary Outcome Measures:
  • Number of blood products transfused [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Need for hysterectomy [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • catheter`s side effects [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Length of hospitalization [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 16
Study Start Date: January 2009
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01373255

Locations
Israel
Haemek Medical Center Recruiting
Afula, Israel
Contact: Raed Salim, MD    97246494355    salim_ra@clalit.org.il   
Contact: Gali Garmi, MD    97246494355    galit_ga@clalit.org.il   
Principal Investigator: Raed Salim, MD         
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
Principal Investigator: Raed Salim Dep. OB/GYN, HaEmek Medical Center, Afula, Israel
  More Information

No publications provided

Responsible Party: Raed Salim, MD, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT01373255     History of Changes
Other Study ID Numbers: 0043-08-EMC, Acreta02
Study First Received: June 10, 2011
Last Updated: April 8, 2014
Health Authority: Israel: Ministry of Health

Keywords provided by 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

ClinicalTrials.gov processed this record on August 20, 2014