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Clinical Trials in Sweden / NCT06033131
Recruiting Phase 3

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

NCT06033131 · tracked via the Priya Life Science Sweden tracker
Sponsor
Lina Bergman
Phase
Phase 3
Started
2024-01-19
Last updated
2026-09-28

Condition(s) studied

Preeclampsia

Investigational drug(s) / intervention(s)

Metformin ER →Placebo

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.

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.

Study 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

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (18)

FacilityCityRegionStatus
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
Sahlgrenska University Hospital Gothenburg Sweden Recruiting
Linköping University Hospital Linköping Sweden Recruiting
Skåne University Hospital Lund Sweden Recruiting
Skåne University Hospital Malmö Sweden Recruiting
Skaraborg Hospital Skövde Sweden Recruiting
Karolinska University Hospital Huddinge Stockholm Sweden Recruiting
Karolinska University Hospital Solna Stockholm Sweden Recruiting
Danderyd Hospital Stockholm Sweden Recruiting
Norra Älvsborgs County Hospital Trollhättan Sweden Recruiting
Norrland´s University Hospital Umeå Sweden Recruiting
Uppsala University Hospital Uppsala Sweden Recruiting
Västmanlands Hospital Västerås Västerås Sweden Recruiting

Other trials for the same condition

The PreEclampsia Postpartum Prevention Trial Recruiting
Probiotic Supplementation During Pregnancy in Women With High-Risk Pregnancies Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06033131 on ClinicalTrials.gov ↗ ← All trials in Sweden