Adverse Pregnancy OutcomesGESTA-SCORENCT06798649
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
A study testing The intervention in the GESTA-SCORE study involves providing detailed feedback from vascular imaging to women who have experienced adverse pregnancy outcomes (APOs). in people with Adverse Pregnancy Outcomes and Cardiovascular Diseases, run by Maternal-Infantil Vall d´Hebron Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Adverse Pregnancy Outcomes, Cardiovascular Diseases
- What is being tested?
- The intervention in the GESTA-SCORE study involves providing detailed feedback from vascular imaging to women who have experienced adverse pregnancy outcomes (APOs).
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2027to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- History of major cardiovascular events or clinically significant cardiovascular disease, including myocardial infarction, angina, stroke, heart failure, resuscitated cardiac arrest, or atrial fibrillation.
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read more
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.
Read the detailed description
GESTA-SCORE investigates whether an early, structured cardiovascular prevention strategy improves postpartum blood pressure control beyond guideline-based standard care in women with preeclampsia. The rationale is that systematic identification of modifiable cardiovascular risk factors, combined with personalized management and digital health support, may improve the transition from pregnancy-related care to longer-term cardiovascular prevention.
The study combines a prospective, randomized, controlled trial in women with preeclampsia with two non-randomized observational comparison cohorts. Following a baseline cardiovascular assessment within six weeks after delivery, women with preeclampsia will be randomized in a 1:1 ratio to personalized cardiovascular prevention or guideline-based standard care. Follow-up assessments will take place at 3, 6 and 12 months postpartum.
The intervention integrates cardiovascular risk assessment with individualized preventive care. Clinical findings will guide blood pressure management, review and adjustment of antihypertensive treatment when indicated, cardiometabolic and kidney health assessment, and recommendations addressing modifiable lifestyle factors. Digital health monitoring will support participant engagement and clinical follow-up. Healthcare professionals will remain responsible for interpreting clinical information and making treatment decisions.
The standard care group will receive postpartum assessment and management according to applicable clinical practice guidelines, including antihypertensive treatment, cardiovascular risk management and referral when clinically indicated. The randomized comparison will assess the incremental benefit of the structured, personalized prevention pathway. All participants will receive clinically indicated care throughout the study.
The observational cohorts will include women with adverse pregnancy outcomes other than preeclampsia and women without adverse pregnancy outcomes. These participants will undergo cardiovascular assessments at the same scheduled postpartum time points while receiving appropriate usual care. Their inclusion will provide context for interpreting cardiovascular recovery after preeclampsia and allow assessment of differences in postpartum trajectories across pregnancy outcome groups. Comparisons involving these cohorts will be observational and will be interpreted separately from the randomized treatment comparison.
A standardized blood pressure measurement procedure will be applied across the randomized groups and observational cohorts to reduce measurement variability. Trained personnel will use validated automated upper-arm devices and appropriately sized cuffs after a seated rest period. Repeated readings will be obtained at each assessment using a consistent procedure. The timing of the baseline assessment relative to delivery will also be recorded.
The primary randomized comparison will account for baseline systolic blood pressure. Repeated follow-up assessments will characterize blood pressure evolution and cardiovascular recovery throughout the first postpartum year. Together, the randomized and observational components will evaluate the added value of structured prevention after preeclampsia and describe postpartum cardiovascular health across different pregnancy outcomes.
- Being tested
- The intervention in the GESTA-SCORE study involves providing detailed feedback from vascular imaging to women who have experienced adverse pregnancy outcomes (APOs).
- Keywords
- cardiovascular disease, vascular imaging, adverse pregnancy outocomes, preeclampsia, gestational diabetes, preterm birth, cardiovascular prevention, vascular health, clinical trial, health of women
- Medical subject headings
- Cardiovascular Diseases, Pre-Eclampsia, Diabetes, Gestational, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The intervention in the GESTA-SCORE study involves providing detailed feedback from vascular imaging to women who have experienced adverse pregnancy outcomes (APOs).Other
This is aimed at assessing whether such feedback can encourage the adoption of healthier lifestyles and enhance adherence to preventive treatments, thereby potentially reducing the incidence of postpartum hypertension and other cardiovascular diseases.
Components of the Intervention:
Vascular Imaging:
Women in the intervention group undergo advanced vascular imaging using ultrasound technology to detect the presence of arterial plaques vs. no information about vascular images in the standard manag group.
The images are analyzed to assess the extent of vascular health, focusing on areas typically affected by cardiovascular risks such as the carotid arteries.
Feedback Delivery:
Detailed results from the vascular imaging are provided to the participants in a comprehensible format by healthcare professionals specialized in cardiovascular health.
This feedback session includes a thorough explanation of the findings, highlighting areas of concern and potential risks.
| Study group | Role | What they receive |
|---|---|---|
| Stantard management | No intervention | Women with preeclampsia randomized to receive standard postpartum clinical care according to current national and international clinical practice guidelines. |
| Intervention group - images vision | Experimental | Women with preeclampsia randomized to receive an early, structured, personalized cardiovascular prevention program in addition to guideline-based clinical care. Receives: Other: The intervention in the GESTA-SCORE study involves providing detailed feedback from vascular imaging to women who have experienced adverse pregnancy outcomes (APOs). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean systolic blood pressure at 12 months postpartum
Mean systolic blood pressure measured using a validated automated upper-arm device after 5 minutes of seated rest. Three readings will be obtained approximately 1 minute apart; the average of the second and third will be used. Intervention and Standard care groups will be compared, adjusting for baseline systolic blood pressure.
Measured: From the delivery until 1 year after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start1 Jun 2027 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse Pregnancy OutcomesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maternal-Infantil Vall d´Hebron Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Goya, MD, PhD, Maternal-Infantil Vall d´Hebron Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06798649
- Sponsor's protocol ID
- Hospital Vall d'Hebron
- Other IDs
- GESTA-SCORE TRIAL
- Acronym
- GESTA-SCORE
- Status last verified
- Oct 2026
- First submitted
- 20 Jan 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06798649
- Acronym / sponsor ID
- GESTA-SCORE / Hospital Vall d'Hebron
- Keywords
- cardiovascular disease, vascular imaging, adverse pregnancy outocomes, preeclampsia, gestational diabetes, preterm birth, cardiovascular prevention, vascular health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Maternal-Infantil Vall d´Hebron HospitalUniversity, hospital or other
- Study start
- 1 Jun 2027 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 29 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
GESTA-SCORE investigates whether an early, structured cardiovascular prevention strategy improves postpartum blood pressure control beyond guideline-based standard care in women with preeclampsia. The rationale is that systematic identification of modifiable cardiovascular risk factors, combined with personalized management and digital health support, may improve the transition from pregnancy-related care to longer-term cardiovascular prevention.
The study combines a prospective, randomized, controlled trial in women with preeclampsia with two non-randomized observational comparison cohorts. Following a baseline cardiovascular assessment within six weeks after delivery, women with preeclampsia will be randomized in a 1:1 ratio to personalized cardiovascular prevention or guideline-based standard care. Follow-up assessments will take place at 3, 6 and 12 months postpartum.
The intervention integrates cardiovascular risk assessment with individualized preventive care. Clinical findings will guide blood pressure management, review and adjustment of antihypertensive treatment when indicated, cardiometabolic and kidney health assessment, and recommendations addressing modifiable lifestyle factors. Digital health monitoring will support participant engagement and clinical follow-up. Healthcare professionals will remain responsible for interpreting clinical information and making treatment decisions.
The standard care group will receive postpartum assessment and management according to applicable clinical practice guidelines, including antihypertensive treatment, cardiovascular risk management and referral when clinically indicated. The randomized comparison will assess the incremental benefit of the structured, personalized prevention pathway. All participants will receive clinically indicated care throughout the study.
The observational cohorts will include women with adverse pregnancy outcomes other than preeclampsia and women without adverse pregnancy outcomes. These participants will undergo cardiovascular assessments at the same scheduled postpartum time points while receiving appropriate usual care. Their inclusion will provide context for interpreting cardiovascular recovery after preeclampsia and allow assessment of differences in postpartum trajectories across pregnancy outcome groups. Comparisons involving these cohorts will be observational and will be interpreted separately from the randomized treatment comparison.
A standardized blood pressure measurement procedure will be applied across the randomized groups and observational cohorts to reduce measurement variability. Trained personnel will use validated automated upper-arm devices and appropriately sized cuffs after a seated rest period. Repeated readings will be obtained at each assessment using a consistent procedure. The timing of the baseline assessment relative to delivery will also be recorded.
The primary randomized comparison will account for baseline systolic blood pressure. Repeated follow-up assessments will characterize blood pressure evolution and cardiovascular recovery throughout the first postpartum year. Together, the randomized and observational components will evaluate the added value of structured prevention after preeclampsia and describe postpartum cardiovascular health across different pregnancy outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stantard management | No intervention | –Women with preeclampsia randomized to receive standard postpartum clinical care according to current national and international clinical practice guidelines. |
| Intervention group - images vision | Experimental | Other: The intervention in the GESTA-SCORE study involves providing detailed feedback from vascular imaging to women who have experienced adverse pregnancy outcomes (APOs).Women with preeclampsia randomized to receive an early, structured, personalized cardiovascular prevention program in addition to guideline-based clinical care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- History of major cardiovascular events or clinically significant cardiovascular disease, including myocardial infarction, angina, stroke, heart failure, resuscitated cardiac arrest, or atrial fibrillation.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The intervention in the GESTA-SCORE study involves providing detailed feedback from vascular imaging to women who have experienced adverse pregnancy outcomes (APOs).This is aimed at assessing whether such feedback can encourage the adoption of healthier lifestyles and enhance adherence to preventive treatments, thereby potentially reducing the incidence of postpartum hypertension and other cardiovascular diseases. Components of the Intervention: Vascular Imaging: Women in the intervention group undergo advanced vascular imaging using ultrasound technology to detect the presence of arterial plaques vs. no information about vascular images in the standard manag group. The images are analyzed to assess the extent of vascular health, focusing on areas typically affected by cardiovascular risks such as the carotid arteries. Feedback Delivery: Detailed results from the vascular imaging are provided to the participants in a comprehensible format by healthcare professionals specialized in cardiovascular health. This feedback session includes a thorough explanation of the findings, highlighting areas of concern and potential risks. | Other | Intervention group - images vision |
Primary outcome
Mean systolic blood pressure at 12 months postpartum
Time frame: From the delivery until 1 year after delivery
Mean systolic blood pressure measured using a validated automated upper-arm device after 5 minutes of seated rest. Three readings will be obtained approximately 1 minute apart; the average of the second and third will be used. Intervention and Standard care groups will be compared, adjusting for baseline systolic blood pressure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing The intervention in the GESTA-SCORE study involves providing detailed feedback from vascular imaging to women who have experienced adverse pregnancy outcomes (APOs). in people with Adverse Pregnancy Outcomes and Cardiovascular Diseases, run by Maternal-Infantil Vall d´Hebron Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria M Goya, PhD (+34934893085, mariagoya@mac.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean systolic blood pressure at 12 months postpartum (time frame: From the delivery until 1 year after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.