Status:
RECRUITING
PI4 - A Trial Assessing Metformin to Prolong Gestation in Preterm Preeclampsia
Lead Sponsor:
Lina Bergman
Collaborating Sponsors:
The Swedish Research Council
Conditions:
Preeclampsia
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief 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. The...
Detailed Description
Preeclampsia is globally responsible for 60,000 maternal deaths per year, and far greater numbers of fetal losses. Preterm preeclampsia is a severe variant with the highest rates of neonatal morbidity...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2029
Estimated Enrollment :
294 Patients enrolled
Trial Details
Trial ID
NCT06033131
Start Date
January 19 2024
End Date
July 31 2029
Last Update
April 9 2025
Active Locations (9)
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1
Falu Lasarett
Falun, Sweden, 79129
2
Sahlgrenska University Hospital
Gothenburg, Sweden, 416 85
3
Linköping University Hospital
Linköping, Sweden, 581 85
4
Skåne University Hospital
Lund, Sweden, 221 85