Clinical Trial: Balloon Catheters in Cases of Abnormal Placentation
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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 Summary:
Sponsor: HaEmek Medical Center, Israel
Current Primary Outcome: Number of blood products transfused [ Time Frame: 5 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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: Same as current
Information By: HaEmek Medical Center, Israel
Dates:
Date Received: June 10, 2011
Date Started: January 2009
Date Completion:
Last Updated: June 14, 2015
Last Verified: June 2015
