Clinical trial NCT02538887: Use of a Supplemental Radiofrequency Detection System Subsequent to Manual Counting of Vaginal Textiles Following Vaginal Birth
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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Gossyphiboma
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2015-09-02
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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).

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.

Eligibility 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.

Primary outcomes:
measure: Number of patients for whom surgical sponge counts can't be reconciled
timeFrame: at the time of radio frequency surgical detection
measure: Number of patients for whom an X-ray was required
timeFrame: at the time of radio frequency surgical detection
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Teresa Byrd, MD
role: PRINCIPAL_INVESTIGATOR
References: