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Use of a Supplemental Radiofrequency Detection System Subsequent to Manual Counting of Vaginal Textiles Following Vaginal Birth

NCT ID: NCT02538887

Last Updated: 2020-11-05

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

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-05-31

Brief Summary

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The purpose of this study is to evaluate the FDA-approved Radio Frequency Surgical Detection System (RFDS) as a non-radiological means to ease the process of detecting retained sponges and reconciling sponge counts in the labor and delivery room (following vaginal birth).

Detailed Description

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This study proposes to evaluate the FDA-approved Radio Frequency Surgical Detection System (RFDS) as a non-radiological means to ease the process of detecting retained sponges and reconciling sponge counts in the labor and delivery room (following vaginal birth). It would not replace any of the current standard-of-care safety mechanisms already in place at the study site to prevent retained sponges. All safeguards remain enforced: counting, visual inspection, and x-rays if indicated by standard protocol. The system being studied involves the surgeon scanning the subject's vaginal area using a spherical device placed 1cm above the symphysis pubis. This static scan will serve to detect any retained cotton textiles within the vaginal cavity after birth. This Verisphere, a reusable device, is encased in a sterile sheath during use. It does not come into direct contact with the subject's vagina, but hovers above the pelvic/vaginal region. If any radio-frequency tagged sponges remain inside the subject, a signal alerts the surgical team to remove them. The visible console displays a confirmation code once the scan is complete. This confirmation code is kept as part of the medical record once absence of retained textiles is confirmed. Once the provider is assured there is no retained item, the same device may be used to scan trash receptacles to locate a missing textile if the pre- and post-delivery sponge/gauze count remains incongruent. This alleviates the need for the assistant personnel to manually "dig" through soiled materials for sponge localization.

Conditions

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Gossyphiboma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Radio Frequency Surgical Detection

Radio Frequency Surgical Detection

Intervention Type DEVICE

Interventions

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Radio Frequency Surgical Detection

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adults only, 18 years or older
* Admitted as inpatients to labor and delivery; patients must be in anticipation of vaginal delivery

Exclusion Criteria

* Urgent or emergent admissions under the influence of preoperative medication, drugs or alcohol.
* Age less than 18 years,
* The patient does not understand English well enough to adequately understand the study.
* Hesitancy of the patient to participate or family reluctance based on the study doctor's opinion.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Teresa Byrd, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Other Identifiers

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HSC-MS-15-0535

Identifier Type: -

Identifier Source: org_study_id