2023-510382-10-00RecruitingPhase 3
Metformin for the prolongation of pregnancy in preterm preeclampsia: the PI-NL trial
Amsterdam UMC8 sites in 1 country180 target enrollmentStarted: September 24, 2024Last updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 180
- Locations
- 8
- Primary Endpoint
- Gestational prolongation (in days)
Study Overview
Brief Summary
To assess whether metformin, compared to placebo, prolongs gestation (for at least 5 more days) in pregnant individuals with preterm PE.
Study Design
- Allocation
- Randomized
- Primary Purpose
- Treatment phase
- Masking
- Double (Subject, Investigator, Carer)
Eligibility Criteria
- Ages
- 18 years to 64 years (18-64 Years)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Aged 18 years or older
- •Singleton pregnancy
- •Gestational age between 23+0 and 31+6 weeks
- •Estimated fetal weight >400 grams
- •There is no clear indication (maternal or fetal) or intention, by both the treating multidisciplinary team and the patient after counseling, to immediately deliver (or directly after corticosteroid administration) or to terminate the pregnancy otherwise
- •A diagnosis of PE, according to PI-NL criteria
- •Ability to understand English or Dutch
- •Ability and willingness to provide written informed consent
Exclusion Criteria
- •Aged <18 years
- •Multiple pregnancy
- •Current use of metformin or a clinical indication for the use of metformin
- •A decision for immediate delivery (including cases where corticosteroids are administered with planned delivery directly after completion of treatment) or termination of pregnancy (e.g., due to disease severity in the patient combined with a dismal prognosis for the fetus), as made by the treating multidisciplinary team and the parent(s)
- •Contraindication(s) for use of metformin
- •Use of drugs that might interact with metformin
- •Suspicion of a major fetal anomaly and/or chromosomal abnormality
- •Unable or unwilling to (completely) understand or provide informed consent, due to language, culture, or other barriers
Outcomes
Primary Outcomes
Gestational prolongation (in days)
Gestational prolongation (in days)
Secondary Outcomes
- Combined endpoint of maternal adverse outcome, consisting of maternal death (death during pregnancy or within 42 days of delivery), eclampsia, pulmonary edema, severe renal impairment, cerebrovascular accident, placental abruption, and/or liver hematoma or rupture.
- Combined endpoint of fetal adverse outcome, consisting of intrauterine fetal death (IUFD, including intrapartum death), suboptimal fetal condition based on the heart rate pattern on the CTG (as judged by the treating clinician), and/or fetal growth restriction (FGR)
- Combined endpoint of neonatal adverse outcome, consisting of neonatal death (within 28 days of birth), intraventricular hemorrhage (grade III or IV), retinopathy of prematurity requiring treatment, necrotizing enterocolitis (grade II or higher), bronchopulmonary dysplasia, neonatal sepsis, and/or cystic periventricular leukomalacia (grade II or higher)
Investigators
PI-NL Research Team
Scientific
Amsterdam UMC
Study Sites (8)
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