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

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ClinicalTrials.gov Identifier: NCT02538887
Recruitment Status : Withdrawn (Sponsor dissolved before study started)
First Posted : September 2, 2015
Last Update Posted : November 5, 2020
Sponsor:
Information provided by (Responsible Party):
The University of Texas Health Science Center, Houston

Brief Summary:
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).

Condition or disease Intervention/treatment
Gossyphiboma Device: Radio Frequency Surgical Detection

Detailed Description:
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.

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Use of a Supplemental Radiofrequency Detection System Subsequent to Manual Counting of Vaginal Textiles Following Vaginal Birth: A Prospective Effectiveness and Efficiency Study For Sponge Tracking
Estimated Study Start Date : November 2015
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : May 2016

Group/Cohort Intervention/treatment
Radio Frequency Surgical Detection Device: Radio Frequency Surgical Detection



Primary Outcome Measures :
  1. Number of patients for whom surgical sponge counts can't be reconciled [ Time Frame: at the time of radio frequency surgical detection ]
  2. Number of patients for whom an X-ray was required [ Time Frame: at the time of radio frequency surgical detection ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All subjects will be inpatients at UTHealth/Memorial Hermann Hospital (and affiliates) who are awaiting vaginal birth. Subjects will be identified upon admittance to Labor and Delivery triage.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02538887


Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Teresa Byrd, MD The University of Texas Health Science Center, Houston
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Responsible Party: The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02538887    
Other Study ID Numbers: HSC-MS-15-0535
First Posted: September 2, 2015    Key Record Dates
Last Update Posted: November 5, 2020
Last Verified: November 2020