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Could a common diabetes drug help delay preterm birth in preeclampsia?

NCT ID NCT06033131

Disease control Sponsor: Lina Bergman Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 3 times

Summary

This phase 3 trial tests whether metformin, a diabetes drug, can safely prolong pregnancy in women with preterm preeclampsia. Currently, the only treatment is early delivery, which risks the baby's health. The study will enroll 294 women across Nordic countries, giving them metformin or a placebo from diagnosis until delivery. The goal is to see if metformin can extend gestation, increase birth weight, and reduce time babies need in neonatal care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Metformin (a diabetes drug)
What this could lead to
If it works, this could offer a way to safely prolong pregnancy in preterm preeclampsia, reducing complications from early delivery.
What could go wrong
This is still a trial, and metformin may not effectively delay delivery. Side effects like nausea or diarrhea are possible, and results may not apply to all populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 294 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2024

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Birth Weight preeclampsia Premature Birth

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Preeclampsia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    17 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Akershus University Hospital

    RECRUITING

    Lørenskog, N-1474, Norway

  • Danderyd Hospital

    RECRUITING

    Stockholm, 182 88, Sweden

  • Falu Lasarett

    RECRUITING

    Falun, 79129, Sweden

  • Helsinki University Hospital

    NOT_YET_RECRUITING

    Helsinki, 00290, Finland

  • Karolinska University Hospital Huddinge

    RECRUITING

    Stockholm, 14157, Sweden

  • Karolinska University Hospital Solna

    RECRUITING

    Stockholm, 17176, Sweden

  • Linköping University Hospital

    RECRUITING

    Linköping, 581 85, Sweden

  • Norra Älvsborgs County Hospital

    RECRUITING

    Trollhättan, 461 74, Sweden

  • Norrland´s University Hospital

    RECRUITING

    Umeå, 901 85, Sweden

  • Oslo University Hospital

    RECRUITING

    Oslo, 0372, Norway

  • Sahlgrenska University Hospital

    RECRUITING

    Gothenburg, 416 85, Sweden

  • Skåne University Hospital

    RECRUITING

    Lund, 221 85, Sweden

  • Skåne University Hospital

    RECRUITING

    Malmö, 205 02, Sweden

  • Södra Älvsborgs Hospital

    RECRUITING

    Borås, 50455, Sweden

  • Tampere University Hospital

    RECRUITING

    Tampere, 33520, Finland

  • Uppsala University Hospital

    RECRUITING

    Uppsala, 75237, Sweden

  • Västmanlands Hospital Västerås

    RECRUITING

    Västerås, 72335, Sweden

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