Clinical trial NCT06798649: 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
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: Maternal-Infantil Vall d´Hebron Hospital
Sponsor class: OTHER
First posted: 2025-01-29
Enrollment: 318
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Hypertension rate after one year of the delivery
timeFrame: From the delivery until 1 year after delivery
Secondary outcomes:
Other outcomes:
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