产妇聊天与护理研究：预防黑人产妇严重发病的实用随机临床试验的原理和设计。

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-02-21 DOI:10.1016/j.cct.2025.107850

Stephanie L. Fitzpatrick , Jennifer Polo , Patti Ephraim , Elizabeth Vrany , Codruta Chiuzan , Melissa Basile , Ciaran P. Friel , Khatiya Chelidze Moon , Emily Silvia , Hallie Bleau , Wanda Nicholson , Dawnette Lewis

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MOMs Chat & Care Study: Rationale and design of a pragmatic randomized clinical trial to prevent severe maternal morbidity among Black birthing people

Background

Black birthing people are disproportionately affected by severe maternal morbidity (SMM). The MOMs Chat & Care Study (R01NR021134) is a pragmatic, randomized clinical trial designed to test the effectiveness of an integrated care model to facilitate timely, appropriate care for high-risk Black birthing people and reduce the risk for SMM.

Methods

We will recruit 674 adult, English and Spanish-speaking Black birthing people who are less than 17 weeks gestational age, considered high risk based on the Obstetrics-Comorbidity Index and/or history of preeclampsia, and receive care at a Northwell Health obstetric practice. Participants will be randomized to either MOMs High Touch or Low Touch. In both intervention arms participants will receive close monitoring via chatbot technology and navigation to timely care and services by the MOMs team throughout the prenatal and postpartum periods, Fitbit to track physical activity, and bi-weekly postpartum telehealth visits up to 6-weeks postpartum. MOMs High Touch will also receive 12 bi-weekly self-management support telehealth visits during pregnancy and a home blood pressure monitor. The two arms will be compared on incidence of SMM at labor and delivery (Aim 1), SMM-related hospitalizations at 1-month and 1-year postpartum (Aim 1a), time to preeclampsia diagnosis and treatment (Aim 2), perceived social support (Aim 3), and physical activity trajectories (exploratory Aim 4). Mixed methods will be used to examine facilitators and barriers to intervention implementation (Aim 5).

Conclusion

Findings from this study will inform how to feasibly implement an effective and sustainable integrated care approach to address SMM disparities.

Registration of Clinical Trials: This trial is registered on www.ClinicalTrials.gov (NCT06335381).

Protocol version: 07/22/2024, 24–0131-NH.

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.