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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: GESTA-COR Trial, a Prospective Randomised Clinical Trial
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.
Detailed Description: The GESTACOR study explores the proactive use of vascular imaging to improve cardiovascular health management in women who have experienced adverse pregnancy outcomes (APOs). This trial uniquely integrates advanced imaging techniques with traditional cardiovascular health assessments to evaluate the efficacy of visual feedback on health behaviour and management. Methodology: Participants are randomly assigned to two groups: one receiving detailed imaging feedback and the other receiving standard care without specific imaging results. Vascular imaging involves state-of-the-art ultrasound techniques to detect arterial plaque, which could be indicative of heightened cardiovascular risk. Over 12 months, participants undergo regular health assessments, including blood pressure monitoring, lipid profiling, and glucose testing, complemented by behavioural health evaluations to capture lifestyle modifications and adherence to prescribed medical regimens. Expected Impacts: The trial is structured to assess whether detailed feedback on vascular health can lead directly to better health outcomes through improved patient engagement and adherence to preventive measures. Outcomes of this research may lead to new guidelines for postpartum women, particularly those with APOs, emphasizing early detection and intervention for cardiovascular risk factors. Innovations and Advancements: GESTA-COR is among the first studies to assess the direct impact of detailed vascular imaging feedback in a postpartum setting. The study's design allows for the collection of significant data on the interplay between visual health information and patient-driven health management. By focusing on a targeted female population traditionally underrepresented in cardiovascular research, GESTA-COR aims to fill a crucial gap in medical research and potential clinical practice, emphasizing gender-specific risk factors and tailored interventions. The findings could pave the way for integrated care approaches that significantly enhance long-term cardiovascular health in postpartum women.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Start Date
June 1, 2026
Primary Completion Date
December 31, 2028
Completion Date
December 31, 2029
Last Updated
September 29, 2025
318
ESTIMATED participants
The intervention in the GESTACOR study involves providing detailed feedback from vascular imaging to women who have experienced adverse pregnancy outcomes (APOs).
OTHER
Lead Sponsor
Maternal-Infantil Vall d´Hebron Hospital
NCT06909773
NCT06505109
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06189313