Clinical Research Directory

A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia

Sponsor: Maternal-Infantil Vall d´Hebron Hospital

Summary

GESTA-SCORE is a prospective, randomized clinical trial designed to evaluate whether an early, personalized cardiovascular prevention strategy can achieve a clinically meaningful 6 mmHg reduction in systolic blood pressure at one year postpartum compared with guideline-based standard care in women with preeclampsia. Women with preeclampsia will be randomly assigned in a 1:1 ratio to one of two groups. The Intervention group will receive a structured cardiovascular prevention program based on early identification of cardiovascular risk factors, personalized clinical assessment, digital health monitoring and targeted preventive interventions. The Standard care group will receive postpartum care, including blood pressure assessment, antihypertensive treatment when indicated, cardiovascular risk management and clinical follow-up, in accordance with current clinical practice guidelines. All participants will receive appropriate medical care, and no clinically indicated treatment will be withheld. The study will also include two non-randomized observational comparison cohorts: women with other adverse pregnancy outcomes (APOs), such as gestational diabetes, preterm birth or fetal growth restriction, and women without APOs. These cohorts will help researchers understand differences in blood pressure evolution and cardiovascular recovery during the first year after childbirth. Participants will undergo an initial cardiovascular assessment during the first six weeks postpartum, followed by scheduled assessments at 3, 6 and 12 months after delivery. Blood pressure will be measured at each assessment using a validated automated upper-arm device and a standardized protocol. After five minutes of seated rest, three consecutive measurements will be obtained, approximately one minute apart. The average of the second and third measurements will be used as the blood pressure value for each assessment. The primary outcome will be mean systolic blood pressure at 12 months postpartum, comparing the Intervention and Standard care groups and adjusting for baseline systolic blood pressure measured during the first six weeks postpartum. The study is designed to detect a between-group difference of 6 mmHg. Secondary objectives include evaluating hypertension, cardiometabolic and kidney health, lifestyle changes and differences in postpartum cardiovascular recovery between women with preeclampsia, other APOs and pregnancies without APOs. GESTA-SCORE aims to establish whether early, personalized cardiovascular prevention can improve blood pressure control beyond current guideline-based care and contribute to more effective cardiovascular prevention after pregnancy.

Official title: A Prospective Randomized Clinical Trial to Reduce Blood Pressure at One Year Postpartum in Women With Preeclampsia, With Non-randomized Comparison Cohorts of Women With Other Adverse Pregnancy Outcomes and Pregnancies Without Adverse Outcomes: GESTA-SCORE Trial

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