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

Launched by LINA BERGMAN · Sep 10, 2023

Keywords

ClinConnect Summary

This clinical trial, called the PI4 trial, is studying whether a medication called metformin can help women with preterm preeclampsia carry their pregnancies longer. Preeclampsia is a serious condition that can affect both the mother and the baby, and the only current treatment is to deliver the baby. This trial aims to see if metformin, a drug often used to manage diabetes, might improve outcomes for mothers and their babies by prolonging the pregnancy, increasing the baby’s weight at birth, and reducing the time the baby needs to stay in the hospital after birth.

To be eligible for this trial, women must be at least 18 years old, diagnosed with preeclampsia, and between 22 and 33 weeks pregnant with a single baby. They also need to give their consent to participate. If women join the trial, they will be randomly assigned to receive either metformin or a placebo (a dummy treatment) and will be closely monitored by healthcare professionals throughout the study. This trial is currently recruiting participants, and it is important for those considering joining to discuss it with their healthcare provider to ensure they meet the criteria and understand the process.

Gender

FEMALE

Eligibility criteria

• 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