Balloon Catheters in Cases of Abnormal Placentation

Post Partum Bleeding Clinical Trial

— Accreta  

Official title:

Balloon Catheter for Occlusion of the Pelvic Vasculature as an Adjuvant Therapy in Cases of Placenta Accreta

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01373255
• Other study ID #: 0043-08-EMC
• Secondary ID: Acreta02
• Status: Completed
• Phase: N/A
• First received: June 10, 2011
• Last updated: June 14, 2015
• Start date: January 2009
• Est. completion date: April 2015

Study information

• Verified date: June 2015
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• pregnant women age 18-45

• antepartum diagnosis of placenta accreta

Exclusion Criteria:

• women who refuse to participate

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Placenta Accreta
• Post Partum Bleeding
• Postpartum Hemorrhage

Intervention

Procedure:
• internal iliac catheterization
Women in this arm will undergo internal iliac artery catheterization prior to the cesarean delivery

Locations

Country	Name	City	State
Israel	Haemek Medical Center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of blood products transfused		5 years	Yes
Secondary	Need for hysterectomy		5 years	Yes
Secondary	catheter`s side effects		5 years	Yes
Secondary	Length of hospitalization		5 years	Yes