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
Study ID
NCT06798649
Status
Not Yet Recruiting

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Conditions

  • Adverse Pregnancy Outcomes
  • Cardiovascular Diseases

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • The intervention in the GESTACOR study involves providing detailed feedback from vascular imaging to women who have experienced adverse pregnancy outcomes (APOs). — OTHER
    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.

Study Details

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.

Key Dates

First listed
Jan 29, 2025
Start date
Jun 1, 2026
Status verified
Jan 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
318 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • No Intervention: Stantard management
    Women with APOs RECEIVE standard health information but NO receive detailed vascular imaging results.
  • Experimental: Intervention group - images vision
    Women with APOs RECEIVE standard health information PLUS vascular imaging results.

Primary Outcome Measure

Hypertension rate after one year of the delivery [ Time Frame: From the delivery until 1 year after delivery ]

Central Contacts

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