Идёт набор NCT06645106

Offering Routine and Rapid Point of Care (POC) Syphilis Testing in Pregnant Patients Presenting to the Emergency Department

Без фазы С лечением Syphilis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Rapid Point of Care (POC) Syphilis testing.
Кому может быть актуально: Состояния в реестре: Syphilis. Базовые параметры: 18 лет — 50 лет · Женщины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The purpose of this study is to offer routine lab-based and rapid point of care (POC) syphilis diagnostic testing in the emergency department (ED) and obstetrical (OB) triage , thereby increasing screening and treatment initiation for pregnant patients without prenatal care or with no documented syphilis results during the index pregnancy in other to increase rates of full treatment to determine if the implementation of a robust linkage to care program for pregnant patients with positive rapid POC results will more likely result in complete treatment for all stages of syphilis and adherence to recommended maternal and newborn longitudinal follow up and to assess factors that contribute to treatment completion after implementation of the intervention will also be analyzed to tailor efforts targeting social and healthcare navigation factors that affect health equity; including poverty, insurance, health literacy and others.

Вмешательства

Устройство Rapid Point of Care (POC) Syphilis testing
Participants will undergo the point of care (POC) FDA cleared syphilis health check (SHC) POC test by a research staff using 50 microliters or 1-3 drops of whole blood via finger stick. The analyzer is handheld, and all testing equipment is temperature stable and does not need refrigeration. The SHC-Syphilis results will be available within 10 minutes of receipt given the published turnaround time to results of 15 minutes per package insert and will be recorded as a research note in the electron

Первичные конечные точки

Percentage of patients without prenatal care during the index pregnancy who received full treatment for all stages of syphilis [Срок оценки: within 1 week of presentation until the time of delivery]
Percentage of patients with no documented syphilis test during the index pregnancy who received full treatment for all stages of syphilis [Срок оценки: within 1 week of presentation until the time of delivery]

Вторичные конечные точки (12)

The percentage of patients who adhere to recommended maternal and newborn longitudinal follow up [Срок оценки: within 1 week of presentation until the time of delivery]
The percentage of patients who adhere to recommended maternal and newborn longitudinal follow up [Срок оценки: at time of postpartum (upto 15 months after delivery)]
Percentage of participants that are married on completion of syphilis treatment [Срок оценки: from presentation to delivery]
Percentage of participants that have health insurance on completion of syphilis treatment [Срок оценки: from presentation to delivery]
Percentage of participants that have psychiatric problems on completion of syphilis treatment [Срок оценки: from presentation to delivery]
Percentage of participants that show substance abuse including alcohol on completion of syphilis treatment [Срок оценки: from presentation to delivery]
Percentage of participants that have unstable housing on completion of syphilis treatment [Срок оценки: from presentation to delivery]
Percentage of participants that have transportation on completion of syphilis treatment [Срок оценки: from presentation to delivery]
Percentage of participants that experience intimate partner violence on completion of syphilis treatment [Срок оценки: from presentation to delivery]
number of prenatal care visits on completion of syphilis treatment [Срок оценки: from presentation to delivery]
Percentage of participants that are married on completion of syphilis treatment [Срок оценки: at time of postpartum (upto 15 months after delivery)]
Percentage of participants that have health insurance on completion of syphilis treatment [Срок оценки: at time of postpartum (upto 15 months after delivery)]

Критерии участия

Критерии включения

Pregnant individuals that are seeking care at University of Texas, Memorial Herman and Lyndon B Johnson sites ED or obstetrical triage units.
No Prenatal care during index pregnancy
No documented syphilis result during the index pregnancy