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Effect of Visual Presentation of Atherosclerotic Plaque on Modification of Arterial Hypertension One Year Postpartum in Women With a History of Adverse Pregnancy Outcomes, and Risk Customization With AI Prediction Algorithms
Sponsor: Maternal-Infantil Vall d´Hebron Hospital
Summary
The GESTA-COR study is a prospective, non-commercial, randomized clinical trial designed to evaluate the impact of detailed vascular imaging feedback on the management of cardiovascular health in women with a history of adverse pregnancy outcomes (APOs). The trial aims to determine if providing these women with detailed images of their vascular status can encourage the adoption of healthier lifestyles and adherence to preventive treatments, thereby potentially reducing the incidence of postpartum hypertension and other cardiovascular diseases. This study involves two randomized groups: Intervention Group (Randomized): Women with APOs receiving detailed vascular imaging results. Standard Management Group (Randomized): Women with APOs who will continue receiving standard health information without vascular imaging results. Participants will be monitored for 12 months postpartum, focusing on blood pressure levels, cardiovascular health indicators, and lifestyle changes.
Official title: Effect of Visual Presentation of Atherosclerotic Plaque on Modification of Arterial Hypertension One Year Postpartum in Women With a History of Adverse Pregnancy Outcomes, and Risk Customization With AI Prediction Algorithms: GESTA-COR Trial, a Prospective Randomised Clinical Trial
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
318
Start Date
2026-06-01
Completion Date
2029-12-31
Last Updated
2025-09-29
Healthy Volunteers
No
Interventions
The intervention in the GESTACOR study involves providing detailed feedback from vascular imaging to women who have experienced adverse pregnancy outcomes (APOs).
This is aimed at assessing whether such feedback can encourage the adoption of healthier lifestyles and enhance adherence to preventive treatments, thereby potentially reducing the incidence of postpartum hypertension and other cardiovascular diseases. Components of the Intervention: Vascular Imaging: Women in the intervention group undergo advanced vascular imaging using ultrasound technology to detect the presence of arterial plaques vs. no information about vascular images in the standard manag group. The images are analyzed to assess the extent of vascular health, focusing on areas typically affected by cardiovascular risks such as the carotid arteries. Feedback Delivery: Detailed results from the vascular imaging are provided to the participants in a comprehensible format by healthcare professionals specialized in cardiovascular health. This feedback session includes a thorough explanation of the findings, highlighting areas of concern and potential risks.