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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

Tracking Information
First Submitted Date  ICMJE June 10, 2011
First Posted Date  ICMJE June 14, 2011
Last Update Posted Date June 16, 2015
Study Start Date  ICMJE January 2009
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 13, 2011)
Number of blood products transfused [ Time Frame: 5 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01373255 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2011)
  • Need for hysterectomy [ Time Frame: 5 years ]
  • catheter`s side effects [ Time Frame: 5 years ]
  • Length of hospitalization [ Time Frame: 5 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Balloon Catheters in Cases of Abnormal Placentation
Official Title  ICMJE Balloon Catheter for Occlusion of the Pelvic Vasculature as an Adjuvant Therapy in Cases of Placenta Accreta
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Post Partum Bleeding
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: internal iliac catheterization
    Women in this arm will undergo internal iliac artery catheterization prior to the cesarean delivery
    Intervention: Procedure: internal iliac catheterization
  • No Intervention: No intervention
    no intervention prior to cesarean
Publications * 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):1022-8. doi: 10.1097/AOG.0000000000001113.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 21, 2015)
24
Original Estimated Enrollment  ICMJE
 (submitted: June 13, 2011)
16
Actual Study Completion Date  ICMJE April 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

- women who refuse to participate

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01373255
Other Study ID Numbers  ICMJE 0043-08-EMC
Acreta02 ( Other Identifier: Emek Medical Center )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Raed Salim, HaEmek Medical Center, Israel
Study Sponsor  ICMJE HaEmek Medical Center, Israel
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Raed Salim Dep. OB/GYN, HaEmek Medical Center, Afula, Israel
PRS Account HaEmek Medical Center, Israel
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP