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NCT06033131From ClinicalTrials.govRecruiting

PI4 - A Trial Assessing Metformin to Prolong Gestation in Preterm Preeclampsia

Preeclampsia Intervention 4 - A Triple Blind Phase III Randomised Controlled Trial Assessing Metformin to Prolong Gestation in Preterm Preeclampsia

  • Preeclampsia

At a glance

Phase
Phase 3
Study type
Interventional
Sponsor
Lina Bergman
Enrolment target
294
Started
19 January 2024
Main results due
31 December 2027
Study sites
18
Registry updated
28 September 2026

Can you take part?

  • Aged 18 years and over.
  • Women only.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
Inclusion Criteria:

* A diagnosis of preeclampsia (defined as hypertension in combination with significant proteinuria (albumin/creatinine ratio \>8 mg/mmol, protein/creatinine ratio\>30 mg/mmol or \>2+ protein on a urinary dipstick) has been made by the attending clinician
* The managing clinicians have made the assessment to proceed with expectant management.
* The subject has given written consent to participate in the study.
* The woman must be 18 years of age or older
* The gestational age is between 22+0 weeks to 33+6 weeks with a viable fetus
* The woman carries a singleton pregnancy

Exclusion Criteria:

* Contraindications to treatment with metformin as outlined in SmPC
* Contraindications for expectant management of preeclampsia such as an immediate indication for delivery according to SFOG guidelines for preeclampsia (https://www.sfog.se/media/338533/pe-riktlinje-230214.pdf).
* Type 1 Diabetes Mellitus
* Current use of metformin
* Known or suspected allergies against metformin
* Reluctance or language difficulties that result in difficulty understanding the meaning of study participation
* Unable to understand the informed consent process
* Previous participation in the study
* Established fetal compromise that necessitates imminent delivery (including planned delivery after 48 hours of corticosteroid treatment). This will be decided by the clinical team before expectant management is offered to the patient.
* Suspicion of a major known fetal anomaly or malformation.
* Renal disease or dysfunction, suggested by a creatinine level greater than or equal to 125 µmol/L or rapidly declining renal function
* Known acute or chronic metabolic acidosis, including diabetic ketoacidosis
* Not suitable for inclusion by the opinion of the investigator

What this study is about

In the sponsor’s own words, from the registry.

Preterm preeclampsia is a severe condition for both the mother and the fetus. Currently, the only treatment available to stop disease progression is termination/delivery of the fetus and placenta. Therefore, preterm preeclampsia carries the highest rates of neonatal morbidity and mortality due to iatrogenic preterm birth. There is evidence suggesting metformin, a drug commonly used to treat diabetes in and outside pregnancy, may be able to counter the pathophysiology of preeclampsia, raising the possibility that it could be used to treat the condition. This multi centre double blind randomised controlled trial aims to investigate if metformin can prolong gestation, lower neonatal length of stay and increase birthweight in a Nordic setting.

Study sites(18)

  • Helsinki University Hospital

    Helsinki, Finland

    Recruiting

  • Tampere University Hospital

    Tampere, Finland

    Recruiting

  • Akershus University Hospital

    Lørenskog, Norway

    Recruiting

  • Oslo University Hospital

    Oslo, Norway

    Recruiting

  • Södra Älvsborgs Hospital

    Borås, Sweden

    Recruiting

  • Falu Lasarett

    Falun, Sweden

    Recruiting

  • Sahlgrenska University Hospital

    Gothenburg, Sweden

    Recruiting

  • Linköping University Hospital

    Linköping, Sweden

    Recruiting

  • Skåne University Hospital

    Lund, Sweden

    Recruiting

  • Skåne University Hospital

    Malmö, Sweden

    Recruiting

  • Skaraborg Hospital

    Skövde, Sweden

    Recruiting

  • Karolinska University Hospital Huddinge

    Stockholm, Sweden

    Recruiting

  • Karolinska University Hospital Solna

    Stockholm, Sweden

    Recruiting

  • Danderyd Hospital

    Stockholm, Sweden

    Recruiting

  • Norra Älvsborgs County Hospital

    Trollhättan, Sweden

    Recruiting

  • Norrland´s University Hospital

    Umeå, Sweden

    Recruiting

  • Uppsala University Hospital

    Uppsala, Sweden

    Recruiting

  • Västmanlands Hospital Västerås

    Västerås, Sweden

    Recruiting

Showing 18 of 18 sites. 18 of the 18 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06033131. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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PI4 - A Trial Assessing Metformin to Prolong Gestation in Preterm Preeclampsia | Trialion