Using Metformin to Extend Pregnancy in Women with Preterm Preeclampsia

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 clinical trial investigates the use of metformin, a diabetes medication, to prolong gestation in women diagnosed with preterm preeclampsia. The study is a multi-center, double-blind, randomized controlled trial conducted in Sweden, aiming to assess whether metformin can delay delivery, improve neonatal outcomes, and increase birth weight. Participants will receive either metformin extended release or a placebo, with outcomes measured in terms of gestational prolongation and neonatal health metrics. The trial builds on previous findings that suggest metformin may modify the disease's progression.

Why it matters

Who can join: the full rules

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

Where it's running

• 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

Study contacts

• Principal investigator: Lina Bergman, Associate professor — Sahlgrenska University Hospital
• Study coordinator: Lina Bergman, Associate Professor
• Email: lina.bergman@obgyn.gu.se
• Phone: 0046-3134307

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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.