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

NCT06798649 | Not Yet Recruiting DMC

• 2 other identifiers: Hospital Vall d'HebronGESTA-COR TRIAL
• Study Type: interventional
• Target: 318
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Adverse Pregnancy Outcomes; Cardiovascular Diseases

Keywords

cardiovascular disease; vascular imaging; adverse pregnancy outocomes; preeclampsia; gestational diabetes; preterm birth; cardiovascular prevention; vascular health; clinical trial; health of women

Outcome Measures

Primary Outcomes (1)

• Hypertension rate after one year of the delivery

  The primary objective of the GESTACOR study is to assess the effectiveness of detailed vascular imaging feedback in reducing the incidence of hypertension one year postpartum in women who have experienced adverse pregnancy outcomes (APOs). The study specifically targets the intervention group, providing them with detailed images of their vascular state to determine if this visual feedback can encourage adherence to healthier lifestyle choices and preventive healthcare measures. By directly linking these interventions with a reduction in postpartum hypertension, the study aims to establish a proactive approach to managing long-term cardiovascular risks in this population.

  From the delivery until 1 year after delivery

Study Arms (2)

Stantard management

NO INTERVENTION

Women with APOs RECEIVE standard health information but NO receive detailed vascular imaging results.

Intervention group - images vision

EXPERIMENTAL

Women with APOs RECEIVE standard health information PLUS vascular imaging results.

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

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.

Intervention group - images vision

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only pregnant individuals after delivery
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged 18 years and older.
• History of one or more adverse pregnancy outcomes (APOs) such as preeclampsia, gestational diabetes, preterm birth before 37 weeks of gestation, or intrauterine growth restriction (fetal weight below the 10th percentile).

You may not qualify if:

• Women with a history of significant cardiovascular events such as myocardial infarction, angina, stroke, heart failure, recovered sudden death, or atrial fibrillation.
• Inability to provide informed consent.
• Women who do not meet the specific APO criteria set out for the study.

Sponsors & Collaborators

• Maternal-Infantil Vall d´Hebron Hospital: lead

MeSH Terms

Conditions

Cardiovascular Diseases; Pre-Eclampsia; Diabetes, Gestational; Premature Birth

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Obstetric Labor, Premature; Obstetric Labor Complications

Central Study Contacts

Maria M Goya, PhD

CONTACT

+34934893085; maria.goya@mac.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinator

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: January 29, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: September 29, 2025

Record last verified: 2025-01