[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600552":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":30,"locations":36,"responsibleParty":59,"collaborators":61,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":26,"enrollmentInfo":78,"targetDuration":26,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":89,"overallStatus":39,"whyStopped":26,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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).",[13],"Drug: Pravastatin 40 mg",{"label":15,"type":16,"description":17,"interventionNames":18},"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).",[19],"Other: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Pravastatin 40 mg","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\u002For fetal growth restriction.",[9],null,{"type":6,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"A visually identical but inactive pill (a placebo),",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":26,"email":35},"Elisa Llurba Olivé, Doctor","CONTACT","+34 93 553 70 48\u002F 93 553 70 41","ellurba@santpau.cat",[37,53],{"facility":38,"status":39,"city":40,"state":26,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Hospital de la Santa Creu i de Sant Pau","RECRUITING","Barcelona","08025","Spain","ES",{"type":45,"coordinates":46},"Point",[47,48],2.15899,41.38879,{"lat":48,"lon":47},[51],{"name":32,"role":33,"phone":52,"phoneExt":26,"email":35},"+34 687743699",{"facility":54,"status":55,"city":40,"state":26,"zip":26,"country":42,"countryCode":43,"cosmosGeoPoint":56,"geoPoint":58,"contacts":26},"Hospital Clínic de Barcelona","NOT_YET_RECRUITING",{"type":45,"coordinates":57},[47,48],{"lat":48,"lon":47},{"type":60,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[62,64,66],{"name":63,"class":6},"Universitat Autonoma de Barcelona",{"name":65,"class":6},"Hospital Clinic of Barcelona",{"name":67,"class":6},"Hospital Universitari Vall d'Hebron Research Institute","100600552","phase-2-statin-intervention-for-severe-early-onset-placental-insufficiency-statin-pre-trial-100600552",false,"NCT07098975","Statin Intervention for Severe Early-Onset Placental Insufficiency. (STATIN-PRE Trial)","Statin Intervention for Severe Early-Onset Placental Insufficiency: A Randomized Controlled Trial Assessing Daily Administration as a Treatment Strategy (STATIN-PRE Trial)","STATIN-PRE","Inclusion Criteria:\n\n* Singleton fetus.\n* Between 24+0 to 29+6 weeks of gestation at the inclusion.\n* 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.\n\nAnd\u002For\n\n* IUGR: Diagnosis of early onset IUGR according to the SMFM classification with umbilical artery Doppler with absent\u002Freversed diastolic flow; or estimated fetal weight \\\u003C10th percentile plus pulsatility index (PI) of umbilical artery Doppler \\>95th percentil.\n* Able to give informed consent.\n\nExclusion Criteria:\n\n* Established maternal or fetal compromise that necessitated immediate delivery\n* Abnormal karyotype, structural abnormalities, or congenital infections.\n* Treatment with pravastatin or other statins prior to inclusion.\n* Lactose intolerance","FEMALE","18 Years",{"count":79,"type":80},154,"ESTIMATED","INTERVENTIONAL",[83],"PHASE2","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.\n\nStatins, 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.\n\nPrevious 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\u002FPlGF ratio was lower than in untreated women, indicating a slower progression of placental insufficiency.\n\nThis 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\u002For 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.\n\nThe 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.\n\nA total of 154 pregnant women are expected to be included in order to meet the study's objectives.",[86,87,88],"Preeclampsia (PE)","Intrauterine Growth Restriction (IUGR)","Placental Insufficiency",[90,91,88,92,93],"Preeclampsia","Intrauterine growth restriction","statins","Pravastatin","2026-02-19",{"date":96,"type":97},"2026-02-23","ACTUAL",{"date":99,"type":97},"2026-01-14",{"date":101,"type":80},"2028-07",{"name":5,"class":6},2]