About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Metformin ER
- Placebo
Treatment groups
Sponsors and collaborators
Lina Bergman
Lead sponsor
Sahlgrenska University Hospital
Sponsor institution
The Swedish Research Council
Collaborator