Overview
Sponsor-declared trial summary
intrauterine growth restriction
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.
Key facts
- Sponsor
- Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13], Diseases [C] - Pathological Conditions, Signs and Symptoms [C23]
- Trial duration
- 14 Jan 2026 → ongoing
- Decision date (initial)
- 2025-06-13
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
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.
Conditions and MedDRA coding
intrauterine growth restriction
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- 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 4
- 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).
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Days of prolongation of pregnancy between inclusion and delivery; continuous (days).
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Pravastatina Kern Pharma 40 mg comprimidos EFG
PRD375525 · Product
- Active substance
- Pravastatin Sodium
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 40 mg milligram(s)
- Max treatment duration
- 10 Week(s)
- Authorisation status
- Authorised
- ATC code
- C10AA03 — PRAVASTATIN
- Marketing authorisation
- 65.939
- MA holder
- KERN PHARMA, S.L.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
- Sponsor organisation
- Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
- Address
- Calle Sant Quinti 77-79
- City
- Barcelona
- Postcode
- 08041
- Country
- Spain
Scientific contact point
- Organisation
- Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
- Contact name
- Alejandra Espinosa
Public contact point
- Organisation
- Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
- Contact name
- Alejandra Espinosa
Locations
1 EU/EEA country · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 154 | 6 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Spain | 2026-01-14 | 2026-01-14 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-519853-12-00 for pub | 4 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | Triptic STATIN-PRE TRIAL | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF HSP for pub | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF UAB for pub | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC pravastatina | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis MS 2024-519853-12-00 for pub | 4 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-02-17 | Spain | Acceptable 2025-06-09
|
2025-06-13 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-11-06 | Spain | Acceptable 2025-12-15
|
2026-01-09 |