Use of metformin to prolong pregnancy in preterm preeclampsia in the Netherlands

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, triple-blind, randomized, placebo-controlled trial in the Netherlands compares metformin hydrochloride to placebo in pregnant individuals with preterm preeclampsia between 23+0 and 31+6 weeks gestation. The goal is to determine if metformin safely prolongs gestation and reduces adverse maternal, fetal, and neonatal outcomes. Secondary goals include evaluating cost-effectiveness and analyzing neonatal outcomes such as birth weight and length of hospital stay. The study builds on prior data suggesting metformin may reduce inflammation and improve endothelial function in preterm preeclampsia. Eligible participants must have singleton pregnancies, confirmed preterm preeclampsia with proteinuria, and no immediate plan for delivery or pregnancy termination.

Why it matters

Who can join: the full rules

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

Where it's running

• Amsterdam UMC
  Amsterdam, Netherlands Recruiting

Study contacts

• Principal investigator: R.C. Painter, Prof, MD, PhD — Amsterdam UMC
• Study coordinator: M. Khelil, MD
• Email: PI_NL@amsterdamumc.nl
• Phone: +31 20 566 9111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.