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Balloon Catheters in Cases of Abnormal Placentation

NCT01373255 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2015-06-16

No results posted yet for this study

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.

Conditions

  • Post Partum Bleeding

Interventions

PROCEDURE

internal iliac catheterization

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

Sponsors & Collaborators

  • HaEmek Medical Center, Israel

    lead OTHER

Principal Investigators

  • Raed Salim · Dep. OB/GYN, HaEmek Medical Center, Afula, Israel

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01373255 on ClinicalTrials.gov