About this 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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- The intervention in the GESTACOR study involves providing detailed feedback from vascular imaging to women who have experienced adverse pregnancy outcomes (APOs).