Recruiting

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

ClinicalTrials.gov IDNCT06033131

PhasePHASE3

Enrollment294

SponsorLina Bergman

Age18 Years

SexFEMALE

I'm interested View official listing

Conditions studied

Preeclampsia

About this study

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.

Interventions

Drug: Metformin ER — Metformin ER, one gram three times daily taken orally. Once the participants have been recruited, they will start by taking one 500 mg tablet three times a day. If well tolerated it will be increased day two to a maximum of two tablets three times a day. Treatment will continue until delivery. If there are side effects that are not tolerable, the dose will be decreased and the participant will remain blinded. Each participant will keep a treatment diary and number of tablets taken will be documented by the participant or hospital staff. The study will not alter or interfere with treatment or care routinely given for preterm preeclampsia.
Drug: Placebo — Placebo, two tablets three times daily taken orally. Once the participants have been recruited, they will start by taking one tablet three times a day. If well tolerated it will be increased day two to a maximum of two tablets three times a day. Treatment will continue until delivery. If there are side effects that are not tolerable, the dose will be decreased and the participant will remain blinded. Each participant will keep a treatment diary and number of tablets taken will be documented by the participant or hospital staff. The study will not alter or interfere with treatment or care routinely given for preterm preeclampsia.

Primary outcomes

Pregnancy prolongation (From randomisation to delivery, measured in days and hours, up to 105 days)

Eligibility information

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

Study locations

Helsinki University Hospital, Helsinki, 00290 Finland
Tampere University Hospital, Tampere, 33520 Finland
Akershus University Hospital, Lørenskog, N-1474 Norway
Oslo University Hospital, Oslo, 0372 Norway
Södra Älvsborgs Hospital, Borås, 50455 Sweden
Falu Lasarett, Falun, 79129 Sweden
Sahlgrenska University Hospital, Gothenburg, 416 85 Sweden
Linköping University Hospital, Linköping, 581 85 Sweden
Skåne University Hospital, Lund, 221 85 Sweden
Skåne University Hospital, Malmö, 205 02 Sweden

Showing 10 of 17 reported sites. See the official listing for all locations.

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.