STATIN-PRE trial
- Conditions
- intrauterine growth restrictionpreeclampsia
- Registration Number
- 2024-519853-12-00
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised, recruitment pending
- Sex
- Female
- Target Recruitment
- 154
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.
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.
Active liver disease, including persistent and unexplained elevations of serum transaminases (3 times above the upper limit).
Study & Design
- Study Type
- Not specified
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Days of prolongation of pregnancy between inclusion and delivery; continuous (days). Days of prolongation of pregnancy between inclusion and delivery; continuous (days).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Hospital De La Santa Creu I Sant Pau
🇪🇸Barcelona, Spain
Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
🇪🇸Barcelona, Spain
Universitat Autonoma De Barcelona
🇪🇸Bellaterra, Spain
Hospital Clinic De Barcelona
🇪🇸Barcelona, Spain
Hospital De La Santa Creu I Sant Pau🇪🇸Barcelona, SpainELISA LLURBASite contact935537048ELlurba@santpau.cat