Balloon Catheters in Cases of Abnormal Placentation (Accreta)

HaEmek Medical Center, Israel

Status: Completed

Conditions: Post Partum Bleeding

Treatments: Procedure: internal iliac catheterization

Study type: Interventional

Funder types: Other

Identifiers

NCT01373255

0043-08-EMC

Acreta02 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• women who refuse to participate

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

24 participants in 2 patient groups

internal iliac catheterization

Experimental group

Description:

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

Treatment:

Procedure: internal iliac catheterization

No intervention

No Intervention group

Description:

no intervention prior to cesarean