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规划被遗忘的妊娠第四个三月期:一项平行组随机对照试验,以测试产后规划干预与标准产前护理的效果。

Planning for the forgotten fourth trimester of pregnancy: A parallel group randomized control trial to test a postpartum planning intervention vs. standard prenatal care.

机构信息

Emory University School of Medicine, Department of Gynecology and Obstetrics, Atlanta, Georgia, United States; Emory University Rollins School of Public Health, Department of Epidemiology, 1518 Clifton Road NE Office 3023, Atlanta, Georgia, United States.

Emory University School of Medicine, Department of Gynecology and Obstetrics, Atlanta, Georgia, United States.

出版信息

Contemp Clin Trials. 2024 Aug;143:107586. doi: 10.1016/j.cct.2024.107586. Epub 2024 Jun 3.

Abstract

BACKGROUND

Black and brown birthing people experience persistent disparities in adverse maternal health outcomes, partially due to inadequate perinatal care. The goal of this study is to design and evaluate a patient-centered intervention for obstetric patients with one or more cardiometabolic risk factors for severe maternal morbidity [gestational diabetes, diabetes mellitus, hypertensive disorders of pregnancy (chronic hypertension, preeclampsia, eclampsia, or gestational hypertension), or preconception obesity (BMI > 30)] to promote postpartum visit attendance.

METHODS

To address identified unmet needs for postpartum support and barriers to postpartum care, we developed 20 thematic postpartum planning modules, each with corresponding patient educational materials, community resources, care coordination protocols, and clinician support tools (decision aids, electronic medical record prompts and fields). During prenatal care encounters, a research coordinator delivers the educational content (in English or Spanish), facilitates the participant's planning and shared decision-making, provides the participant with resources, and documents decisions in the electronic medical record. We will randomize 320 eligible patients with a 1:1 ratio to the intervention or standard prenatal care and evaluate the impact on postpartum visit attendance at 4-12 weeks and secondary outcomes (postpartum mental health, perceived future maternal and cardiometabolic risk, contraceptive use, primary care use, readmission, and patient satisfaction with care).

DISCUSSION

Through engagement with patients and community stakeholders, we developed a guideline-based, locally tailored intervention to address drivers of engagement with postpartum care for high-risk obstetric patients. If demonstrated to be effective, the educational materials and electronic medical record based-tool can be adapted to other settings.

TRIAL REGISTRATION

This trial was registered on ClinicalTrials.gov (NCT05430815) on June 23, 2022.

摘要

背景

黑人和棕色人种产妇在不良母婴健康结局方面持续存在差异,部分原因是围产期护理不足。本研究旨在设计并评估一种以患者为中心的干预措施,针对患有一种或多种心血管代谢严重产妇发病率风险因素的产科患者[妊娠糖尿病、糖尿病、妊娠高血压疾病(慢性高血压、子痫前期、子痫或妊娠期高血压)或孕前肥胖(BMI>30)],以促进产后访视的参与。

方法

为了解决产后支持需求未得到满足和产后护理障碍的问题,我们开发了 20 个主题性产后计划模块,每个模块都有相应的患者教育材料、社区资源、护理协调协议和临床医生支持工具(决策辅助工具、电子病历提示和字段)。在产前保健就诊期间,研究协调员提供教育内容(英语或西班牙语),促进参与者的计划和共同决策,为参与者提供资源,并在电子病历中记录决策。我们将以 1:1 的比例随机分配 320 名符合条件的患者到干预组或标准产前护理组,并评估对产后 4-12 周访视参与度以及次要结局(产后心理健康、感知未来的母婴和心血管代谢风险、避孕措施使用、初级保健使用、再入院和对护理的满意度)的影响。

讨论

通过与患者和社区利益相关者的合作,我们开发了一种基于指南、针对当地情况的干预措施,以解决高风险产科患者参与产后护理的驱动因素。如果证明有效,教育材料和基于电子病历的工具可以适应其他环境。

试验注册

该试验于 2022 年 6 月 23 日在 ClinicalTrials.gov(NCT05430815)上注册。

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