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)

September 26, 2025 updated by: Maria Goya, MD, PhD, Maternal-Infantil Vall d´Hebron Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

318

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hypertension rate after one year of the delivery
Time Frame: From the delivery until 1 year after 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maternal-Infantil Vall d´Hebron Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

January 20, 2025

First Submitted That Met QC Criteria

January 27, 2025

First Posted (Actual)

January 29, 2025

Study Record Updates

Last Update Posted (Estimated)

September 29, 2025

Last Update Submitted That Met QC Criteria

September 26, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hospital Vall d'Hebron
  • GESTA-COR TRIAL (Other Identifier: Vall d'Hebron Hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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