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New treatment option for Preeclampsia
Official title PI4 - A Trial Assessing Metformin to Prolong Gestation in Preterm Preeclampsia
ClinicalTrials.gov ID: NCT06033131
What this study is testing
What is Metformin ER?
Metformin ER is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for preeclampsia.
Also referred to as Glucophage SR 500 mg prolonged release tablets.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- A diagnosis of preeclampsia (defined as hypertension in combination with significant proteinuria (albumin/creatinine ratio \>8 mg/mmol...
- 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
You likely can't join if
- 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...
- 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
See the full eligibility 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...
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Helsinki, Finland
- Tampere, Finland
- Lørenskog, Norway
- Oslo, Norway
- Borås, Sweden
- Falun, Sweden
- Gothenburg, Sweden
- Linköping, Sweden
- Lund, Sweden
- Malmö, Sweden
- Stockholm, Sweden
- Trollhättan, Sweden
- Umeå, Sweden
- Uppsala, Sweden
- Västerås, Sweden
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Helsinki, Finland; Tampere, Finland; Lørenskog, Norway; Oslo, Norway; Borås, Sweden; Falun, Sweden and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.