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临床试验/NCT07009106
NCT07009106已完成不适用

Improving Postpartum Care Knowledge and Visit Attendance in Expecting Persons With Diabetes Through an Educational Video Pilot Study

Women and Infants Hospital of Rhode Island2 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2023年8月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
86
试验地点
2
主要终点
Change in baseline postpartum care knowledge after video education intervention

研究概览

简要总结

Each year in the United States, about 700 people die from pregnancy-related causes. More than half of these deaths occur after delivery, during what is often called the "fourth trimester." Many of these deaths-up to 80%-are believed to be preventable. In the first week postpartum, the most common causes of death are heavy bleeding, high blood pressure, and infection. After the first week, heart problems such as cardiomyopathy are the leading causes of death. In addition to the risk of life-threatening complications, health issues like diabetes and high blood pressure during pregnancy can increase a person's risk of developing long-term conditions such as heart disease and type 2 diabetes. Despite the importance of postpartum care, up to 40% of individuals do not attend their postpartum check-up. Attendance is especially low among people who are younger, publicly insured, or from underserved communities. Among individuals with diabetes in pregnancy, postpartum care is critical to monitor blood sugar levels, assess for type 2 diabetes, manage complications, and ensure long-term follow-up with a primary care provider. However, many do not attend this visit or receive recommended screenings. Common reasons include feeling fine, time constraints, and a lack of understanding about the purpose of the visit.

The study was conducted as a pilot randomized controlled trial at a tertiary care center among pregnant individuals with type 1, type 2, or gestational diabetes. Participants were randomly assigned to receive either usual care or to watch a 3-minute animated video during a prenatal visit. After enrolling, all participants completed a baseline survey using a secure platform (REDCap) assessing their knowledge about the postpartum period and care expectations. The video was available in English and Spanish and covered key information about what to expect after delivery, warning signs for complications, and why postpartum care is important. Immediately after viewing the video, participants in the intervention group repeated the knowledge-based questions to assess changes in their understanding. Investigators reviewed the electronic medical records to assess postpartum visit scheduling and attendance. This study is designed to determine whether a brief, accessible educational video can improve postpartum care engagement among individuals with diabetes in pregnancy. If effective, this type of video intervention could be implemented more widely to improve maternal health outcomes, particularly in high-risk populations.

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
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Diagnosis of Type 1 Diabetes, Type 2 Diabetes, or gestational diabetes
  • 28 weeks gestational age or later
  • 18-50 years of age
  • English or Spanish speaking

排除标准

  • 未提供

结局指标

主要结局

Change in baseline postpartum care knowledge after video education intervention

时间窗: From pre-video survey during enrollment to immediately after video intervention (1-2 weeks later)

Among participants randomized to the video intervention group, change in postpartum care knowledge will be assessed using a structured multiple-choice questionnaire administered before and immediately after viewing the educational video on a secure platform (REDCap). Knowledge questions assess understanding of postpartum expectations, complications, and importance of postpartum care. Improvement will be measured by comparing total scores on the pre- and post-video surveys.

Rate of attendance to the postpartum visit

时间窗: 12 weeks after delivery

The rate of attendance to a postpartum visit within 12 weeks after delivery will be assessed and compared between groups (video vs. usual care), as documented in the electronic medical record. Attendance will be defined as in-person or telehealth contact with an obstetric provider or primary care provider focused on postpartum care. Differences between groups will be compared using Fisher's exact test.

次要结局

未报告次要终点

研究者

发起方
Women and Infants Hospital of Rhode Island
申办方类型
Other
责任方
Principal Investigator
主要研究者

Laurie Griffin

Principal Investigator

Women and Infants Hospital of Rhode Island

研究点 (2)

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