A Phase 2 interventional study of Pravastatin 40 mg and Placebo in Preeclampsia (PE), Intrauterine Growth Restriction (IUGR) and Placental Insufficiency, sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau. Recruiting at 2 sites in Spain. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Phase 2, Interventional, and Supportive care
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Among 25 studies in Pre-Eclampsia with a site in Spain — 13 open to participants now, 14 under way, 1 of them phase 3. Pre-Eclampsia · Spain.
Among the 25 studies in Pre-Eclampsia with a site in Spain, this one is the 11th largest by planned enrollment of the 13 interventional ones that give a count, is one of 5 that started in 2026, is the only one in phase 2, reaches primary completion later than 7 of the 13 other live ones, and was the 19th registered.
917 studies on the registry are indexed under Pre-Eclampsia; 244 are open to participants now.
Browse Pre-Eclampsia studies →13 of the 25 studies in Pre-Eclampsia with a site in Spain are open now. Recruiting first, the newest first:
Institut d'Investigacions Biomèdiques August Pi i Sunyer · Sites in Spain
Ages 18+ · Women only
Hospital Universitari Vall d'Hebron Research Institute · Sites in Spain
Ages 18+ · Women only
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia · Sites in Spain
Ages 18+ · Women only
Aristotle University Of Thessaloniki · Sites in Spain, Bulgaria, Greece
Ages 18+ · Women only · Healthy volunteers
Hospital Universitari Vall d'Hebron Research Institute · Sites in Spain
Ages 18+ · Women only
A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →
Of the 162 Pre-Eclampsia studies recruiting now, 81 (50%) set no upper age limit and 80 (49%) stop at 75 or younger; 18 take children under 18; 60 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
25 studies; the count open now beside each. This study's row is marked.
First in 2012; this study’s year is marked. 5 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 154 is above the median of 110 across 481 interventional studies indexed under Pre-Eclampsia.
Median enrollment 386 across the 13 interventional studies, 1,280 across the 12 observational. Of the 7 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
2 of 25 have an industry lead sponsor. The 10 most frequent:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau is the lead sponsor of 343 studies on the registry; 65 are open to participants now.
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau has 7 studies filed under Pre-Eclampsia — fewer than ten, so there is no comparison to draw.
4 of the studies in Pre-Eclampsia with a site in Spain that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04766866Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauSFlt1/PlGF and Planned Delivery to Prevent Preeclampsia At Term. | 2026-12-31 |
| NCT06716242iPremomValidation of the MaiRa Preeclampsia Test for Screening Early/Late Preeclampsia in First and Second Trimesters | 2027-06 |
| NCT07656532University of SalamancaPolyphenol Intake, Mediterranean Diet Adherence, and Oxidative Stress in Pregnancy | 2027-09-01 |
| NCT07098975Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauStatin Intervention for Severe Early-Onset Placental Insufficiency. (STATIN-PRE Trial) | 2027-11 |
Add all 4 to your calendar (.ics) → With an account.
Among the 25 studies in Pre-Eclampsia with a site in Spain, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
And/or
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
40 mg of pravastatin (2 pills of 20 mg at bedtime) from inclusion to delivery (estimated median of 4 weeks, maximum of 10 weeks).
Drug: Pravastatin 40 mg
placebo of the same presentation as the active drug from inclusion to delivery (estimated median of 4 weeks, maximum of 10 weeks).
Other: Placebo
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.
A visually identical but inactive pill (a placebo),
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
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.
Time frame: At delivery
Preterm birth before 34 weeks of gestation
Time frame: At delivery
Birth weight
Time frame: At delivery
Neonatal acidosis
arterial pH \<7.10+ base excess \<=12 mmol/L. Binary (yes/no)
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
In the echocardiographic ultrasound assessment at inclusion, at delivery and at 6 months after delivery
Time frame: 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)
Time frame: at the time of diagnosis and delivery
Biomarkers in umbilical cord blood
sFlt1, PlGF and NTProBNP
Time frame: At delivery
Concentrations in plasma/serum
of dense low density lipoprotein (dense LDL), apolipoprotein CIII (apoCIII), and TAS
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.
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).
Time frame: 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.
Time frame: 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
Time frame: At delivery
Plan to share: 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.
No publications or documents are linked to this record.
Started Jan 2026 (actual). Primary completion is estimated for Nov 2027, 22 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Pravastatin
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau →