Balloon Catheters in Cases of Abnormal Placentation
- Conditions
- Post Partum Bleeding
- Interventions
- Procedure: internal iliac catheterization
- Registration Number
- NCT01373255
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 24
- pregnant women age 18-45
- antepartum diagnosis of placenta accreta
- women who refuse to participate
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description internal iliac catheterization internal iliac catheterization Women in this arm will undergo internal iliac artery catheterization prior to the cesarean delivery
- Primary Outcome Measures
Name Time Method Number of blood products transfused 5 years
- Secondary Outcome Measures
Name Time Method catheter's side effects 5 years Need for hysterectomy 5 years Length of hospitalization 5 years
Trial Locations
- Locations (1)
Haemek Medical Center
🇮🇱Afula, Israel