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Balloon Catheters in Cases of Abnormal Placentation

Not Applicable
Completed
Conditions
Post Partum Bleeding
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
Inclusion Criteria
  • pregnant women age 18-45
  • antepartum diagnosis of placenta accreta
Exclusion Criteria
  • women who refuse to participate

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Number of blood products transfused5 years
Secondary Outcome Measures
NameTimeMethod
Length of hospitalization5 years
catheter's side effects5 years
Need for hysterectomy5 years

Trial Locations

Locations (1)

Haemek Medical Center

🇮🇱

Afula, Israel

Haemek Medical Center
🇮🇱Afula, Israel

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