Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
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RecruitingPhase 3interventionalRules rewrite

Phase 3: testing Metformin Hydrochloride for Pre-Eclampsia Onset Less Than 37 Weeks

The goal of this study is to find out if pregnant individuals with preterm preeclampsia (PE) who are treated with metformin can stay pregnant for longer, and if this is safe(r) for the mother and child. Preterm PE affects about 1 in 100 pregnant individuals in the Netherlands.

Official registry: https://clinicaltrials.gov/study/NCT06452498 · Amsterdam UMC · enrollment listed as 180

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Metformin Hydrochloride, or Placebo. The registry lists allocation as randomized. The goal of this study is to find out if pregnant individuals with preterm preeclampsia (PE) who are treated with metformin can stay pregnant for longer, and if this is safe(r) for the mother and child.

They plan to enroll about 180 people at Amsterdam. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Metformin for the Prolongation of Pregnancy in Preterm Preeclampsia

Interventions: Metformin Hydrochloride, Placebo

Primary outcome (registry wording): Number of days between randomization and delivery

Who it is for (from inclusion criteria)

  • Ages 18 Years to 50 Years
  • Women only
  • All of the following:
  • Aged 18 years or older
  • Singleton pregnancy
  • Gestational age between 23+0 and 31+6 weeks
  • 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

Public study contact (from the registry)

M. Khelil, MD

+31 20 566 9111

PI_NL@amsterdamumc.nl

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT06452498 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06452498?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06452498?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary