NCT07098975 Statin Intervention for Severe Early-Onset Placental Insufficiency. (STATIN-PRE Trial)
| NCT ID | NCT07098975 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
| Condition | Preeclampsia (PE) |
| Study Type | INTERVENTIONAL |
| Enrollment | 154 participants |
| Start Date | 2026-01-14 |
| Primary Completion | 2027-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 154 participants in total. It began in 2026-01-14 with a primary completion date of 2027-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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 both the mother and the baby 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, yhe 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.
Eligibility Criteria
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. * Lactose intolerance
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07098975 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Preeclampsia (PE). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07098975 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07098975 currently recruiting?
Yes, NCT07098975 is actively recruiting participants. Contact the research team at ellurba@santpau.cat for enrollment information.
Where is the NCT07098975 trial being conducted?
This trial is being conducted at Barcelona, Spain, Barcelona, Spain.
Who is sponsoring the NCT07098975 clinical trial?
NCT07098975 is sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau. The trial plans to enroll 154 participants.