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临床试验/NCT04267211
NCT04267211已完成不适用

Prenatal Consult With Illustrated Literature

University of Virginia2 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2017年6月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
82
试验地点
2
主要终点
Maternal Anxiety

研究概览

简要总结

The overall purpose of this study is to determine whether implementing a 'Prenatal Consult Bundle' to the existing prenatal consult, including provision of sample questions, added discussion points and handouts, and a return visit, will decrease parental anxiety and improve information recall. Additionally, this study will determine if this effect is further increased with the use of illustrated literature.

详细描述

This study will be a prospective randomized control trial. Seventy participants will be enrolled for the 'Standard' consult. These women will receive a questionnaire 6-24 hours after their consult. Then 140 participants will be randomized to either the 'Standard Upgrade' or 'Illustrated Upgrade' arm. Randomization will additionally be stratified based on estimated gestational age. These participants will receive an upgraded consult implementing the 'Prenatal Consult Bundle' which emphasizes the parents' role and follow up, with or without an illustrated handout. These participants will receive the same questionnaire 6-24 hours after their consult. Demographic information collected will include maternal age, gravidity, use of magnesium, social support and health literacy. All data will be collected to assess whether either arm of the consult 'upgrade' reduces anxiety or improves knowledge retention after the prenatal consult. Analyses will be completed using Statistical Analysis Software (SAS) using appropriate statistical testing.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Investigator)

入排标准

年龄范围
15 Years 至 99 Years(Child, Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women admitted to OB unit at the University of Virginia Medical Center
  • Estimated gestational age of >25 weeks and <35 weeks

排除标准

  • Non-English Speaking
  • Pregnant women <15 years of age
  • Known critical conditions or congenital anomalies
  • Women who have had any prior prenatal consultations regarding current pregnancy

结局指标

主要结局

Maternal Anxiety

时间窗: Within 48 hours of consultation

Using the State-Trait Anxiety Inventory (STAI), maternal anxiety will be assessed between the two groups

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jonathan Swanson, MD

Associate Professor

University of Virginia

研究点 (2)

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