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Metformin for the prolongation of pregnancy in preterm preeclampsia: the PI-NL trial
EU CTIS ID: 2023-510382-10-00
What this study is testing
To assess whether metformin, compared to placebo, prolongs gestation (for at least 5 more days) in pregnant individuals with preterm PE.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.