NCT06798649Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
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
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 20 Jan 2025
- Start date
- 1 Jun 2027
- Primary completion date
- 31 Dec 2029
- Lead sponsor
- Maternal-Infantil Vall d´Hebron Hospital
- Diseases
- High blood pressure
- NCT number
- NCT06798649
What you commit to
- Study type: Interventional
- Planned participants: 150
- From 1 Jun 2027 to the primary completion date, 31 Dec 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of major cardiovascular events or clinically significant cardiovascular disease, including myocardial infarction, angina, stroke, heart failure, resuscitated cardiac arrest, or atrial fibrillation.
Other
- Unable to provide informed consent.
- Do not meet the eligibility criteria for any of the three predefined study cohorts.
- Unable to complete the baseline cardiovascular assessment within six weeks after delivery.
Who the study is looking for
- Women aged 18 years or older.
- Able to complete the baseline cardiovascular assessment within six weeks after delivery.
- Belong to one of the following three mutually exclusive study cohorts:
- Preeclampsia cohort: Women with preeclampsia during the index pregnancy who are eligible for randomization to the intervention or standard care group.
- Other-APO cohort: Women whose index pregnancy was complicated by adverse pregnancy outcomes other than preeclampsia, including gestational diabetes, preterm birth before 37 weeks of gestation, or fetal growth restriction, defined as estimated fetal weight or birth weight below the 10th percentile according to the study protocol.
- No-APO cohort: Women whose index pregnancy was not complicated by preeclampsia or any other adverse pregnancy outcome specified in the study protocol.
- Able and willing to provide written informed consent and participate in scheduled follow-up assessments.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.