Preeclampsia Intervention Netherlands

Launched by AMSTERDAM UMC · Jun 5, 2024

Keywords

ClinConnect Summary

The Preeclampsia Intervention Netherlands (PI-NL) trial is studying whether a medication called metformin can help pregnant individuals with preterm preeclampsia stay pregnant longer and if it is safe for both the mother and the baby. Preterm preeclampsia is a condition that can happen during pregnancy, causing high blood pressure and other serious issues before the 34th week. This condition affects about 1 in 100 pregnant individuals in the Netherlands and can lead to early delivery, which may pose risks for the baby's health, such as infections and breathing problems.

To participate in this trial, individuals must be at least 18 years old, have a single baby on the way, and be diagnosed with preterm preeclampsia between 23 and 31 weeks of pregnancy. They cannot have any major reasons for immediate delivery or already be taking metformin. Participants will receive standard care, and they will be randomly assigned to either take metformin or a placebo (a non-active look-alike pill), without knowing which one they are receiving. This study aims to gather important information about how metformin may help prolong pregnancy safely in these cases.

Gender

FEMALE

Eligibility criteria

• • Inclusion Criteria
• All of the following:
• • Aged 18 years or older
• • Singleton pregnancy
• • Gestational age between 23+0 and 31+6 weeks
• • A diagnosis of preterm preeclampsia, defined according to modified International Society for the Study of Hypertension in Pregnancy (ISSHP) classification, including only those who have proteinuria (≥300 mg of protein in a 24-hour urine specimen or a protein-creatinine-ratio \>50 in a single urine sample)
• • Estimated fetal weight \>400 grams
• • 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.
• • Ability to understand English or Dutch
• • Ability and willingness to provide written informed consent
• • Exclusion Criteria
• Any of the following:
• • 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 the use of metformin (e.g., severe renal insufficiency, acute metabolic acidosis, severe liver insufficiency)
• • 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