Preeclampsia (PE)Phase 2STATIN-PRENCT07098975
Statin Intervention for Severe Early-Onset Placental Insufficiency. (STATIN-PRE Trial)
A Phase 2 study testing Pravastatin 40 mg in people with Preeclampsia (PE) and Intrauterine Growth Restriction (IUGR), run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 2 sites in Spain.
Trial summary
In pregnancies with placental insufficiency, the only available treatment is close monitoring to determine the point at which the risks of preterm birth for the baby are lower than the risks of continuing the pregnancy. Therefore, safely prolonging pregnancy is the current management goal for this condition. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preeclampsia (PE), Intrauterine Growth Restriction (IUGR), Placental Insufficiency
- What is being tested?
- Pravastatin 40 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 154 participants
- Where
- 2 sitesSpain
- Study dates
- 14 Jan 2026to Jul 2028
- Phase
- Phase 2
- 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
- Singleton fetus.
- Between 24+0 to 29+6 weeks of gestation at the inclusion.
- Early-onset severe PE: women with a diagnosis of severe-preterm PE who are candidates for expectant management and have no clinical indication for immediate delivery, based on the clinical assessments of the attending doctors.
- And/or
- IUGR: Diagnosis of early onset IUGR according to the SMFM classification with umbilical artery Doppler with absent/reversed diastolic flow; or estimated fetal weight <10th percentile plus pulsatility index (PI) of umbilical artery Doppler >95th percentil.
- Able to give informed consent.
Who cannot join
- Established maternal or fetal compromise that necessitated immediate delivery
- Abnormal karyotype, structural abnormalities, or congenital infections.
- Treatment with pravastatin or other statins prior to inclusion.
- Lactose intolerance
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 2 recruiting
- Recruiting
Hospital de la Santa Creu i de Sant Pau
Barcelona, Barcelona, 08025
Elisa Llurba Olivé, Doctor, +34 687743699, ellurba@santpau.cat
- Not yet recruiting
Hospital Clínic de Barcelona
Barcelona, Barcelona
About this study
Official title: Statin Intervention for Severe Early-Onset Placental Insufficiency: A Randomized Controlled Trial Assessing Daily Administration as a Treatment Strategy (STATIN-PRE Trial)
In pregnancies with placental insufficiency, the only available treatment is close monitoring to determine the point at which the risks of preterm birth for the baby are lower than the risks of continuing the pregnancy. Therefore, safely prolonging pregnancy is the current management goal for this condition.
Statins, such as pravastatin, are approved and marketed drugs used to prevent cardiovascular disease. Recent studies suggest that statins may help treat pregnancy complications and prolong pregnancy, thereby avoiding extreme prematurity and improving long-term health outcomes for both mother and baby.
Read more
Previous clinical trials have shown the ability of statins to stabilize angiogenic factors, thus reducing obstetric complications associated with placental insufficiency. In 2015, a study reported that pravastatin was effective in stabilizing blood pressure and reducing proteinuria associated with preeclampsia. More recently, in 2020, it was demonstrated that in pregnant women with fetal growth restriction treated with pravastatin, the sFlt-1/PlGF ratio was lower than in untreated women, indicating a slower progression of placental insufficiency.
This study proposes administering a daily dose of 40 mg of pravastatin between 24 and 29.6 weeks of gestation to mothers diagnosed with preeclampsia and/or fetal growth restriction. One group of women will receive the medication, while another group will receive a visually identical but inactive pill (a placebo), allowing us to determine whether any observed improvement in pregnancy is attributable to the medication. Assignment to the treatment or placebo group will be random, and neither the mothers nor the healthcare professionals caring for them will know which group they are in.
The investigators also aim to examine whether this intervention during pregnancy protects the cardiovascular system. For this reason, the investigators will assess the mother six months after birth using an ultrasound of the heart and blood vessels, and the investigators will also perform a blood test on the mothers. Additionally, the investigators want to explore the needs and expectations of women who experience these complications during pregnancy and postpartum, so that their stories can guide us in finding answers and solutions that are as personalized as possible to the real needs of families. After the visit at six months postpartum, the investigators will follow up with annual phone calls over the next four years to check on the participants' health and their baby's. During each call, the investigators will review the participant's health status and talk about how the participant is feeling. All of this will help us ensure that the treatment does not cause any long-term issues and will improve future care for other mothers and babies.
A total of 154 pregnant women are expected to be included in order to meet the study's objectives.
Read the detailed description
Preeclampsia (PE) and intrauterine growth restriction (IUGR) arise as clinical manifestations of placental insufficiency. While significant strides have been made in the prevention of PE over the past decade, resulting in a noteworthy decline in its prevalence, both PE and IUGR persist as prominent contributors to peripartum morbidity, major causes of prematurity, and sources of neonatal complications and mortality. In severe instances of PE, the potential for serious complications extends throughout pregnancy and the postpartum period, and both entities have implications on long-term maternal and children cardiovascular risks in later life.
Despite the efforts to generate successful therapeutic strategies aimed to prolong pregnancy and attenuate prematurity-related morbidity, presently, the only effective cure is timely delivery, and pharmacological therapy aims to mitigate tertiary complications such as eclampsia or severe hypertension. PE and IUGR are considered orphan diseases by the European Medicines Agency. Therefore, there is an urgent need to investigate novel drugs aimed to improve maternal and neonatal outcomes and mitigate long term sequels. Between 24 and 28 weeks of pregnancy, every day of prolongation of the pregnancy is followed by a 1-2% reduction of neonatal mortality or severe morbidity.
HMG-CoA reductase inhibitors (HMG-CoA-RI), beyond their lipid-lowering effects, have been shown to improve endothelial function, placental perfusion, have anti-inflammatory and anti-oxidant effects, and up-regulation of angiogenesis with their "pleiotropic effects". These HMG-CoA-RI related beneficial properties suggest their potential protective potential during the acute phase of placental insufficiency and subsequent protection on cardiovascular maternal and fetal programming.
It is our WORKING HYPOTHESIS that 40 mgr of oral administration of pravastatin daily will prolong duration of pregnancy and will provide cardioprotection and additional benefits to both mother and neonates to that afforded by conventional management of PE and IUGR.
FIRST AIM: To assess that daily 40 mgr of oral administration of pravastatin in pregnant individuals with PE and/or IUGR between 24.0 and 29.6 weeks of gestation will prolong duration of pregnancy compared to conventional management.
SECOND AIM: Determine whether pravastatin improve cardiac function, placental perfusion, angiogenesis, total antioxidant status (TAS) and lipid profile during pregnancy and after pregnancy in mothers in the intervention group compared to controls.
THIRD AIM: To evaluate changes in genetic expression profile in human tissues after treatment with novel statins' therapy.
FOURTH AIM: To include women's needs and expectations about PE, IUGR and preterm birth and future health in order to improve the success of the translation into real changes in women and infant health.
- Being tested
- Pravastatin 40 mg, Placebo
- Keywords
- Preeclampsia, Intrauterine growth restriction, Placental Insufficiency, statins, Pravastatin
- Medical subject headings
- Pre-Eclampsia, Fetal Growth Retardation, Placental Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pravastatin 40 mgDrug
This study proposes administering a daily dose of 40 mg of pravastatin between 24 and 29.6 weeks of gestation to mothers diagnosed with preeclampsia and/or fetal growth restriction.
PlaceboOther
A visually identical but inactive pill (a placebo),
| Study group | Role | What they receive |
|---|---|---|
| 40mg of pravastatin | Experimental | 40 mg of pravastatin (2 pills of 20 mg at bedtime) from inclusion to delivery (estimated median of 4 weeks, maximum of 10 weeks). Receives: Drug: Pravastatin 40 mg |
| Placebo | Placebo comparator | placebo of the same presentation as the active drug from inclusion to delivery (estimated median of 4 weeks, maximum of 10 weeks). Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days of prolongation of pregnancy between inclusion and delivery.
Measured: From date of randomization until the date of delivery, assesed up to 10 weeks
Secondary outcomes (14)
Maternal pregnancy-related morbidity composite score
Including any of the following:
(i) HELLP syndrome .(ii)Central nervous system dysfunction (iii)Hepatic dysfunction (iv) renal dysfunction . (v)Respiratory dysfunction. (vi)Cardiovascular dysfunction. (vii) Placental abruption. (viii) a requirement for transfusion of blood products red cells, platelets, fresh frozen plasma and cryoprecipitate. Minimum score of 0, maximum score of 8. Higher scores mean worse outcome.
Measured: At delivery
Preterm birth before 34 weeks of gestation
Measured: At delivery
Birth weight
Measured: At delivery
Neonatal acidosis
arterial pH <7.10+ base excess >12 mEq/L
Measured: At delivery
Perinatal mortality
Measured: from 22 weeks of gestation to 28 days post-partum
Days in the neonatal intensive care
Measured: From date of delivery until the date of discharge of the neonatal intensive care or date of death from any cause, whichever came first, assessed up to 3 months
Neonatal morbidity
Measured: At delivery
Maternal cardiac function
In the echocardiographic ultrasound assessment at inclusion, at delivery and at 6 months after delivery
Measured: at inclusion, at delivery and at 6 months after delivery
Biomarkers in maternal blood
soluble fms-like tyrosine kinase 1 (sFlt1) and placental growth factor (PlGF); NTProBNP, continuous (pg/mL)
Measured: at the time of diagnosis and delivery
Biomarkers in umbilical cord blood
sFlt1, PlGF and NTProBNP
Measured: At delivery
Concentrations in plasma/serum
of dense low density lipoprotein (dense LDL), apolipoprotein CIII (apoCIII), and TAS
Measured: Since inlcusion until 6 months after delivery
Increased cardiovascular risk by blood preassure measurement, echocardiographic assessment, global longitudinal strain, carotid-ntima-media thickness, Ophtalmic artery Doppler evaluation, IBERLIFERISK score.
Defined by any of the following (binary(yes/no): (1)Presence of hypertension, defined as stage 1 hypertension (SBP of 130-139 or DBP of 80-89 mmHg) and/or (2)Proteinuria>300 mg/24 hours or renal insufficiency and/or (3)High-risk CVD according to IBERLIFERISK score (score >50%) and/or (4) IMT >p90 according to the Spanish population (5) Abnormal cardiac function in the echocardiographic ultrasound assessment. Abnormal values of the different parameters will be considered according to reference limits in pregnancy and post-partum published in 2023 by the British Society of Echocardiography and/or (6) Abnormal biochemical cardiac markers (NTproBNP, high-sensitivity troponin) and/or (7) Cardiovascular major events (ictus, coronary artery disease, cardiac insufficiency or myocardiopathy).
Measured: 6 months after delivery
Cardiovascular algorithms and cloud-based analysis and decision support system
Initially, we will aggregate patient data from diverse sources like electronic health records, medical imaging, biochemical and lipid results forming a comprehensive patient profile. This data undergoes feature extraction and preprocessing to identify relevant parameters and ensure consistency.
We will develop an algorithm, incorporating machine learning techniques. This algorithm will be of use to predict cardiovascular risks in women after a placental complication. The computational demands are met through the utilization of cloud infrastructure, providing secure storage and real-time processing capabilities. The results generated by this algorithm will be integrated into user-friendly interfaces, forming a decision support system for healthcare professionals. This assists them in making well-informed decisions regarding patient care, treatment plans, and interventions.
Measured: Through study completion, an avarage of 4 years
mRNAs in trophoblast
Gene expression of: IL-6, IFN-γ, TNF-α, VEGFA, VEGFB, FGF2, and RQVEGF Receptor1
Measured: At delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start14 Jan 2026
- Primary completionNov 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preeclampsia (PE)Studies 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- INCLUSION CRITERIA: * Singleton fetus. * Between 24+0 to 29+6 weeks of gestation at the inclusion. * Early-onset severe PE: women with a diagnosis of severe-preterm PE who are candidates for expectant management and have no clinical indication for immediate delivery, based on the clinical assessments of the attending doctors. And/or * IUGR: Diagnosis of early onset IUGR according to the SMFM classification with umbilical artery Doppler with absent/reversed diastolic flow; or estimated fetal weight \<10th percentile plus pulsatility index (PI) of umbilical artery Doppler \>95th percentil. * Able to give informed consent. EXCLUSION CRITERIA: * Established maternal or fetal compromise that necessitated immediate delivery * Abnormal karyotype, structural abnormalities, or congenital infections. * Treatment with pravastatin or other statins prior to inclusion
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Sponsor type
- University, hospital or other
- Collaborators
- Universitat Autonoma de Barcelona, Hospital Clinic of Barcelona, Hospital Universitari Vall d'Hebron Research Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07098975
- Sponsor's protocol ID
- IIBSP-PRE-2024-198
- Acronym
- STATIN-PRE
- Status last verified
- Oct 2026
- First submitted
- 14 Jul 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Aligned with open science principles and Horizon Europe guidelines, our project prioritizes transparency and reproducibility. Data will be openly shared on the Open Science Framework (OSF), guided by FAIT principles for accessibility and reusability. Biobanked samples will be accessible to other researchers, fostering collaboration and further exploration.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Statin Intervention for Severe Early-Onset Placental Insufficiency: A Randomized Controlled Trial Assessing Daily Administration as a Treatment Strategy (STATIN-PRE Trial)
- ClinicalTrials.gov ID
- NCT07098975
- Acronym / sponsor ID
- STATIN-PRE / IIBSP-PRE-2024-198
- Keywords
- Preeclampsia, Intrauterine growth restriction, Placental Insufficiency, statins, Pravastatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Collaborators
- Universitat Autonoma de Barcelona, Hospital Clinic of Barcelona, Hospital Universitari Vall d'Hebron Research Institute
- Study start
- 14 Jan 2026 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 1 Aug 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.
In pregnancies with placental insufficiency, the only available treatment is close monitoring to determine the point at which the risks of preterm birth for the baby are lower than the risks of continuing the pregnancy. Therefore, safely prolonging pregnancy is the current management goal for this condition.
Statins, such as pravastatin, are approved and marketed drugs used to prevent cardiovascular disease. Recent studies suggest that statins may help treat pregnancy complications and prolong pregnancy, thereby avoiding extreme prematurity and improving long-term health outcomes for both mother and baby.
Previous clinical trials have shown the ability of statins to stabilize angiogenic factors, thus reducing obstetric complications associated with placental insufficiency. In 2015, a study reported that pravastatin was effective in stabilizing blood pressure and reducing proteinuria associated with preeclampsia. More recently, in 2020, it was demonstrated that in pregnant women with fetal growth restriction treated with pravastatin, the sFlt-1/PlGF ratio was lower than in untreated women, indicating a slower progression of placental insufficiency.
This study proposes administering a daily dose of 40 mg of pravastatin between 24 and 29.6 weeks of gestation to mothers diagnosed with preeclampsia and/or fetal growth restriction. One group of women will receive the medication, while another group will receive a visually identical but inactive pill (a placebo), allowing us to determine whether any observed improvement in pregnancy is attributable to the medication. Assignment to the treatment or placebo group will be random, and neither the mothers nor the healthcare professionals caring for them will know which group they are in.
The investigators also aim to examine whether this intervention during pregnancy protects the cardiovascular system. For this reason, the investigators will assess the mother six months after birth using an ultrasound of the heart and blood vessels, and the investigators will also perform a blood test on the mothers. Additionally, the investigators want to explore the needs and expectations of women who experience these complications during pregnancy and postpartum, so that their stories can guide us in finding answers and solutions that are as personalized as possible to the real needs of families. After the visit at six months postpartum, the investigators will follow up with annual phone calls over the next four years to check on the participants' health and their baby's. During each call, the investigators will review the participant's health status and talk about how the participant is feeling. All of this will help us ensure that the treatment does not cause any long-term issues and will improve future care for other mothers and babies.
A total of 154 pregnant women are expected to be included in order to meet the study's objectives.
Detailed description
Preeclampsia (PE) and intrauterine growth restriction (IUGR) arise as clinical manifestations of placental insufficiency. While significant strides have been made in the prevention of PE over the past decade, resulting in a noteworthy decline in its prevalence, both PE and IUGR persist as prominent contributors to peripartum morbidity, major causes of prematurity, and sources of neonatal complications and mortality. In severe instances of PE, the potential for serious complications extends throughout pregnancy and the postpartum period, and both entities have implications on long-term maternal and children cardiovascular risks in later life.
Despite the efforts to generate successful therapeutic strategies aimed to prolong pregnancy and attenuate prematurity-related morbidity, presently, the only effective cure is timely delivery, and pharmacological therapy aims to mitigate tertiary complications such as eclampsia or severe hypertension. PE and IUGR are considered orphan diseases by the European Medicines Agency. Therefore, there is an urgent need to investigate novel drugs aimed to improve maternal and neonatal outcomes and mitigate long term sequels. Between 24 and 28 weeks of pregnancy, every day of prolongation of the pregnancy is followed by a 1-2% reduction of neonatal mortality or severe morbidity.
HMG-CoA reductase inhibitors (HMG-CoA-RI), beyond their lipid-lowering effects, have been shown to improve endothelial function, placental perfusion, have anti-inflammatory and anti-oxidant effects, and up-regulation of angiogenesis with their "pleiotropic effects". These HMG-CoA-RI related beneficial properties suggest their potential protective potential during the acute phase of placental insufficiency and subsequent protection on cardiovascular maternal and fetal programming.
It is our WORKING HYPOTHESIS that 40 mgr of oral administration of pravastatin daily will prolong duration of pregnancy and will provide cardioprotection and additional benefits to both mother and neonates to that afforded by conventional management of PE and IUGR.
FIRST AIM: To assess that daily 40 mgr of oral administration of pravastatin in pregnant individuals with PE and/or IUGR between 24.0 and 29.6 weeks of gestation will prolong duration of pregnancy compared to conventional management.
SECOND AIM: Determine whether pravastatin improve cardiac function, placental perfusion, angiogenesis, total antioxidant status (TAS) and lipid profile during pregnancy and after pregnancy in mothers in the intervention group compared to controls.
THIRD AIM: To evaluate changes in genetic expression profile in human tissues after treatment with novel statins' therapy.
FOURTH AIM: To include women's needs and expectations about PE, IUGR and preterm birth and future health in order to improve the success of the translation into real changes in women and infant health.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- INCLUSION CRITERIA: * Singleton fetus. * Between 24+0 to 29+6 weeks of gestation at the inclusion. * Early-onset severe PE: women with a diagnosis of severe-preterm PE who are candidates for expectant management and have no clinical indication for immediate delivery, based on the clinical assessments of the attending doctors. And/or * IUGR: Diagnosis of early onset IUGR according to the SMFM classification with umbilical artery Doppler with absent/reversed diastolic flow; or estimated fetal weight <10th percentile plus pulsatility index (PI) of umbilical artery Doppler >95th percentil. * Able to give informed consent. EXCLUSION CRITERIA: * Established maternal or fetal compromise that necessitated immediate delivery * Abnormal karyotype, structural abnormalities, or congenital infections. * Treatment with pravastatin or other statins prior to inclusion
| Arm | Type | Receives |
|---|---|---|
| 40mg of pravastatin | Experimental | Drug: Pravastatin 40 mg40 mg of pravastatin (2 pills of 20 mg at bedtime) from inclusion to delivery (estimated median of 4 weeks, maximum of 10 weeks). |
| Placebo | Placebo comparator | Other: Placeboplacebo of the same presentation as the active drug from inclusion to delivery (estimated median of 4 weeks, maximum of 10 weeks). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Singleton fetus.
- Between 24+0 to 29+6 weeks of gestation at the inclusion.
- Early-onset severe PE: women with a diagnosis of severe-preterm PE who are candidates for expectant management and have no clinical indication for immediate delivery, based on the clinical assessments of the attending doctors.
- And/or
- IUGR: Diagnosis of early onset IUGR according to the SMFM classification with umbilical artery Doppler with absent/reversed diastolic flow; or estimated fetal weight <10th percentile plus pulsatility index (PI) of umbilical artery Doppler >95th percentil.
Key exclusion criteria (4 listed)
- Established maternal or fetal compromise that necessitated immediate delivery
- Abnormal karyotype, structural abnormalities, or congenital infections.
- Treatment with pravastatin or other statins prior to inclusion.
- Lactose intolerance
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 |
|---|---|---|
| Pravastatin 40 mgThis study proposes administering a daily dose of 40 mg of pravastatin between 24 and 29.6 weeks of gestation to mothers diagnosed with preeclampsia and/or fetal growth restriction. | Drug | 40mg of pravastatin |
| PlaceboA visually identical but inactive pill (a placebo), | Other | Placebo |
Primary outcome
Days of prolongation of pregnancy between inclusion and delivery.
Time frame: From date of randomization until the date of delivery, assesed up to 10 weeks
14 secondary outcomes
Maternal pregnancy-related morbidity composite score
Time frame: At delivery
Preterm birth before 34 weeks of gestation
Time frame: At delivery
Birth weight
Time frame: At delivery
Neonatal acidosis
Time frame: At delivery
Perinatal mortality
Time frame: from 22 weeks of gestation to 28 days post-partum
Days in the neonatal intensive care
Time frame: From date of delivery until the date of discharge of the neonatal intensive care or date of death from any cause, whichever came first, assessed up to 3 months
Neonatal morbidity
Time frame: At delivery
Maternal cardiac function
Time frame: at inclusion, at delivery and at 6 months after delivery
Biomarkers in maternal blood
Time frame: at the time of diagnosis and delivery
Biomarkers in umbilical cord blood
Time frame: At delivery
Concentrations in plasma/serum
Time frame: Since inlcusion until 6 months after delivery
Increased cardiovascular risk by blood preassure measurement, echocardiographic assessment, global longitudinal strain, carotid-ntima-media thickness, Ophtalmic artery Doppler evaluation, IBERLIFERISK score.
Time frame: 6 months after delivery
Cardiovascular algorithms and cloud-based analysis and decision support system
Time frame: Through study completion, an avarage of 4 years
mRNAs in trophoblast
Time frame: At delivery
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 16 Oct 2026.
- Individual participant dataSharing planned: Yes. Aligned with open science principles and Horizon Europe guidelines, our project prioritizes transparency and reproducibility. Data will be openly shared on the Open Science Framework (OSF), guided by FAIT principles for accessibility and reusability. Biobanked samples will be accessible to other researchers, fostering collaboration and further exploration.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pravastatin 40 mg in people with Preeclampsia (PE) and Intrauterine Growth Restriction (IUGR), run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 2 sites in Spain.
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 6 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: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Elisa Llurba Olivé, Doctor (+34 93 553 70 48/ 93 553 70 41, ellurba@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days of prolongation of pregnancy between inclusion and delivery. (time frame: From date of randomization until the date of delivery, assesed up to 10 weeks). 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 16 Oct 2026.