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

ConditionPreeclampsia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorLina Bergman

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

294 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Lina Bergman

Lead sponsor

Sahlgrenska University Hospital

Sponsor institution

The Swedish Research Council

Collaborator