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

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

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).

Study Overview

• Status: Withdrawn
• Conditions: Gossyphiboma
• Intervention / Treatment: 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.

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patients for whom surgical sponge counts can't be reconciled	at the time of radio frequency surgical detection
Number of patients for whom an X-ray was required	at the time of radio frequency surgical detection

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Teresa Byrd, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2015
• Primary Completion (Anticipated): May 1, 2016
• Study Completion (Anticipated): May 1, 2016

Study Registration Dates

• First Submitted: August 31, 2015
• First Submitted That Met QC Criteria: August 31, 2015
• First Posted (Estimate): September 2, 2015

Study Record Updates

• Last Update Posted (Actual): November 5, 2020
• Last Update Submitted That Met QC Criteria: November 3, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: HSC-MS-15-0535