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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 318
- 主要终点
- Hypertension rate after one year of the delivery
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
Stantard management
Women with APOs RECEIVE standard health information but NO receive detailed vascular imaging results.
Intervention group - images vision
Women with APOs RECEIVE standard health information PLUS vascular imaging results.
干预措施: The intervention in the GESTACOR study involves providing detailed feedback from vascular imaging to women who have experienced adverse pregnancy outcomes (APOs). (Other)
结局指标
主要结局
Hypertension rate after one year of the delivery
时间窗: 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.
次要结局
未报告次要终点
研究者
Maria Goya, MD, PhD
Coordinator
Maternal-Infantil Vall d´Hebron Hospital