NCT06033131 PI4 - A Trial Assessing Metformin to Prolong Gestation in Preterm Preeclampsia
| NCT ID | NCT06033131 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Lina Bergman |
| Condition | Preeclampsia |
| Study Type | INTERVENTIONAL |
| Enrollment | 294 participants |
| Start Date | 2024-01-19 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 294 participants in total. It began in 2024-01-19 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Lina Bergman, Associate professor
PRINCIPAL INVESTIGATOR
Sahlgrenska University Hospital
Frequently Asked Questions
Who can join the NCT06033131 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Preeclampsia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06033131 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 294 participants.
Is NCT06033131 currently recruiting?
Yes, NCT06033131 is actively recruiting participants. Contact the research team at lina.bergman@obgyn.gu.se for enrollment information.
Where is the NCT06033131 trial being conducted?
This trial is being conducted at Helsinki, Finland, Tampere, Finland, Lørenskog, Norway, Oslo, Norway and 11 additional locations.
Who is sponsoring the NCT06033131 clinical trial?
NCT06033131 is sponsored by Lina Bergman. The principal investigator is Lina Bergman, Associate professor at Sahlgrenska University Hospital. The trial plans to enroll 294 participants.