Phase III Trial of Metformin to Extend Pregnancy in Women with Preterm Preeclampsia

What this Trial Is About

Preterm preeclampsia is a severe condition affecting both mother and baby, often requiring early delivery that leads to high rates of newborn complications and death. This trial investigates if metformin, a drug commonly used for diabetes, can help delay delivery, improve newborn weight, and reduce time spent in neonatal care in women with preterm preeclampsia in Nordic countries. The study builds on previous research suggesting metformin may modify the disease and improve outcomes. Participants will be randomly assigned to receive either metformin extended release ER tablets or placebo tablets taken orally three times daily. The dose starts at 500 mg three times a day and may increase to 1 gram three times daily as tolerated. Treatment continues until delivery, and dose adjustments may be made if side effects occur. The study is triple-blind, meaning neither participants nor researchers know who receives metformin or placebo. During the study, participants will keep a diary to record tablet intake, and their routine care for preeclampsia will continue without interference. Researchers will measure the length of pregnancy from randomization to delivery, newborn weight at birth, and the duration of neonatal care. Follow-up assessments of mothers and children will occur two years after birth. The study aims to improve outcomes while monitoring safety and treatment adherence.

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