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OpenTrials
Completed

NCT Number: NCT01373255

Balloon Catheters in Cases of Abnormal Placentation

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.

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Key information

Conditions

Post Partum Bleeding Female Urogenital Diseases and Pregnancy Complications Hemorrhage Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Placenta Accreta Placenta Diseases Postpartum Hemorrhage Pregnancy Complications Puerperal Disorders Urogenital Diseases Uterine Hemorrhage

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Haemek Medical Center

Afula, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • women who refuse to participate

Treatment and study plan

internal iliac catheterization

Procedure

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

Other names: internal iliac artery catheterization

Primary outcomes

  1. Number of blood products transfused

    Time frame: 5 years

Secondary outcomes

  1. Need for hysterectomy

    Time frame: 5 years

  2. catheter's side effects

    Time frame: 5 years

  3. Length of hospitalization

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

HaEmek Medical Center, Israel

Other

Registry information

Official study title

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

Acronym: Accreta

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Jun 14, 2011
Registry last updated
Jun 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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