Statin Intervention for Severe Early-Onset Placental Insufficiency. (STATIN-PRE Trial)

NCT07098975 | Recruiting Phase 2 DMC

• 1 other identifier: IIBSP-PRE-2024-198
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 2

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.

Conditions

Preeclampsia (PE); Intrauterine Growth Restriction (IUGR); Placental Insufficiency

Keywords

Preeclampsia; Intrauterine growth restriction; Placental Insufficiency; statins; Pravastatin

Outcome Measures

Primary Outcomes (1)

• Days of prolongation of pregnancy between inclusion and delivery.

  From date of randomization until the date of delivery, assesed up to 10 weeks

Secondary Outcomes (14)

• Maternal pregnancy-related morbidity composite score

  At delivery

• Preterm birth before 34 weeks of gestation

  At delivery

• Birth weight

  At delivery

• Neonatal acidosis

  At delivery

• Perinatal mortality

  from 22 weeks of gestation to 28 days post-partum

Study Arms (2)

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).

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).

Other: Placebo

Interventions

Pravastatin 40 mg DRUG

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.

40mg of pravastatin

Placebo OTHER

A visually identical but inactive pill (a placebo),

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Singleton fetus.
• 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.

You may not qualify if:

• Established maternal or fetal compromise that necessitated immediate delivery
• Abnormal karyotype, structural abnormalities, or congenital infections.
• Lactose intolerance

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead
• Universitat Autonoma de Barcelona: collaborator
• Hospital Clinic of Barcelona: collaborator
• Hospital Universitari Vall d'Hebron Research Institute: collaborator

Study Sites (2)

Hospital de la Santa Creu i de Sant Pau

Barcelona, 08025, Spain

RECRUITING

Hospital Clínic de Barcelona

Barcelona, Spain

NOT YET RECRUITING

MeSH Terms

Conditions

Pre-Eclampsia; Fetal Growth Retardation; Placental Insufficiency

Interventions

Pravastatin

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fetal Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Placenta Diseases

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Central Study Contacts

Elisa Llurba Olivé, Doctor

CONTACT

+34 93 553 70 48/ 93 553 70 41; ellurba@santpau.cat

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: August 1, 2025
• Study Start: January 14, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: February 23, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

ES (2)