Skip to content

Balloon Catheters in Cases of Abnormal Placentation

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01373255
Acronym
Accreta
Enrollment
24
Registered
2011-06-14
Start date
2009-01-31
Completion date
2015-04-30
Last updated
2015-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Partum Bleeding

Keywords

Placenta accreta, Internal iliac artery catheterization, Post partum bleeding

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.

Interventions

PROCEDUREinternal iliac catheterization

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

Sponsors

HaEmek Medical Center, Israel
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

\- women who refuse to participate

Design outcomes

Primary

MeasureTime frame
Number of blood products transfused5 years

Secondary

MeasureTime frame
Need for hysterectomy5 years
catheter's side effects5 years
Length of hospitalization5 years

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026