Balloon Catheters in Cases of Abnormal Placentation

NCT ID: NCT01373255

Last Updated: 2015-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2015-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Post Partum Bleeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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internal iliac catheterization

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

Group Type EXPERIMENTAL

internal iliac catheterization

Intervention Type PROCEDURE

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

No intervention

no intervention prior to cesarean

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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internal iliac catheterization

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

Intervention Type PROCEDURE

Other Intervention Names

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internal iliac artery catheterization

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\- women who refuse to participate
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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HaEmek Medical Center, Israel

OTHER

Sponsor Role lead

Responsible Party

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Raed Salim

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Raed Salim

Role: PRINCIPAL_INVESTIGATOR

Dep. OB/GYN, HaEmek Medical Center, Afula, Israel

Locations

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Haemek Medical Center

Afula, , Israel

Site Status

Countries

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Israel

References

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Salim R, Chulski A, Romano S, Garmi G, Rudin M, Shalev E. Precesarean Prophylactic Balloon Catheters for Suspected Placenta Accreta: A Randomized Controlled Trial. Obstet Gynecol. 2015 Nov;126(5):1022-1028. doi: 10.1097/AOG.0000000000001113.

Reference Type DERIVED
PMID: 26444128 (View on PubMed)

Other Identifiers

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Acreta02

Identifier Type: OTHER

Identifier Source: secondary_id

0043-08-EMC

Identifier Type: -

Identifier Source: org_study_id

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