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Идёт набор NCT06510075

Providing an Optimized and Empowered Pregnancy for You (POPPY) Aim 3: Randomized Controlled Trial

Без фазы С лечением Pregnancy Complications Maternal Distress Adverse Birth Outcomes Infant Conditions

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: Digital Health intervention, Community Health Worker, Digital Health Intervention plus Community Health Worker.
Кому может быть актуально
Состояния в реестре: Pregnancy Complications, Maternal Distress, Adverse Birth Outcomes, Infant Conditions. Базовые параметры: 16 лет — 49 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
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Официальное название

Providing an Optimized and emPowered Pregnancy for You (PᵌOPPY) Aim 3: Randomized Controlled Trial

Обзор

The PᵌOPPY study is designed to support the American Heart Association's mission to improve maternal/infant health outcomes and address inequities in maternal/infant health care. The P3OPPY Project is one of five projects within the American Heart Association P3 EQUATE Network. The overarching goal of the P3 EQUATE American Heart Association Health Equity Research Network (HERN) is to promote equity in Maternal and Infant Health outcomes by identifying innovative and cost-effective strategies to enhance access to quality health information, care, and experiences during pregnancy, postnatal and postpartum/preconception periods, particularly for Black and under-served populations. Collectively, the investigators will collaborate with pregnant and postpartum individuals and their families, hospitals, and communities to discover ways to reduce racism and social problems that contribute to poor health outcomes. In this trial, 400 non-Hispanic Black participants will be randomized to see if 2 promising interventions (digital health interventions and community health workers) reduce adverse pregnancy outcomes.

Подробное описание

The aim of this trial is to assess whether an existing Digital Heath Intervention (DHI) and/or a Community Health Worker (CHW) Intervention will reduce adverse maternal and perinatal outcomes. A 2 x 2 factorial randomized controlled trial of Non-Hispanic Black (NHB) patients living in high area deprivation index (ADI) communities will be conducted. Participants (n=400) will be randomized 1:1:1:1 to one of 4 arms: 1) standard prenatal care (PNC) alone, or 2) standard PNC plus DHI, or 3) standard PNC plus CHW, or 4) standard PNC, plus DHI and CHW.

The PᵌOPPY study is designed to support the American Heart Association's mission to improve maternal/infant health outcomes and address inequities in maternal/infant health care. The promise of digital health and community health worker engagement makes PᵌOPPY interventions potentially transformative, sustainable, and scalable for Non-Hispanic Black mothers and their infants from under-served communities in Alabama and beyond.

Вмешательства

  • Поведенческое Digital Health intervention
    Health care information delivered via a link in a text message that is then opened in a secure browser.
  • Поведенческое Community Health Worker
    Health care information delivered via CHW.
  • Поведенческое Digital Health Intervention plus Community Health Worker
    Health care information delivered via DHI plus CHW

Первичные конечные точки

  • Weighted Adverse Outcome Score (WAOS) [Срок оценки: [Time Frame: From randomization to 6 weeks postpartum]]
Вторичные конечные точки (8)
  • Outpatient Prenatal Care Visits [Срок оценки: Duration of pregnancy through 6 weeks postpartum]
  • Preterm Birth [Срок оценки: At birth]
  • Neonatal birthweight [Срок оценки: At birth]
  • Cesarean delivery [Срок оценки: At birth]
  • Maternal blood transfusion [Срок оценки: Duration of pregnancy through 6 weeks postpartum]
  • Breastfeeding intent [Срок оценки: From randomization to delivery of the infant(s)]
  • Maternal postpartum readmission [Срок оценки: From discharge from the delivery-associated hospitalization to 6 weeks postpartum]
  • Neonatal hospital readmission [Срок оценки: Birth to 6 weeks of life]

Критерии участия

Критерии включения

  • Self Identifies as Non-Hispanic Black
  • Between 16-49 years old
  • Pregnant individuals between 8⁰ - 22⁶ weeks gestational age
  • Live singleton or dichorionic twin gestation
  • Dating sonogram at <23 weeks gestation,
  • Area Deprivation Index (ADI) National 4th or 5th Quintile
  • Planning to deliver at UAB Hospital
  • Speaks and writes in English
  • No indication for delivery at the time of enrollment

Критерии исключения

  • Declines randomization
  • Speaks or writes in languages other than English
  • Currently incarcerated
  • Fetal demise diagnosed prior to enrollment
  • Known major structural chromosomal abnormalities prior to enrollment
  • Participated in POPPY Pilot

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Профилактика

Центры проведения

США · 1 центр
  • University of Alabama at Birmingham — Birmingham

Идентификаторы

NCT: NCT06510075 · IRB-300013085 · 22HERNPMI985239

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗