Using Metformin to Extend Pregnancy in Women with Preterm Preeclampsia
Preeclampsia Intervention 4 - A Triple Blind Phase III Randomised Controlled Trial Assessing Metformin to Prolong Gestation in Preterm Preeclampsia
This study is testing if the diabetes drug metformin can help women with preterm preeclampsia have longer pregnancies and healthier babies.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 294 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Sahlgrenska University Hospital Academic / other |
| Locations | 17 sites (Helsinki and 16 other locations) |
| Trial ID | NCT06033131 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of metformin, a diabetes medication, to prolong gestation in women diagnosed with preterm preeclampsia. The study is a multi-center, double-blind, randomized controlled trial conducted in Sweden, aiming to assess whether metformin can delay delivery, improve neonatal outcomes, and increase birth weight. Participants will receive either metformin extended release or a placebo, with outcomes measured in terms of gestational prolongation and neonatal health metrics. The trial builds on previous findings that suggest metformin may modify the disease's progression.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women aged 18 and older, diagnosed with preeclampsia between 22 and 33 weeks of gestation, and carrying a singleton fetus.
Not a fit: Patients with type 1 diabetes, contraindications to metformin, or those requiring immediate delivery due to severe preeclampsia will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for mothers and their babies by prolonging pregnancy and reducing neonatal complications.
How similar studies have performed: Previous studies, such as the Preeclampsia Intervention 2 trial, have shown promising results with metformin in delaying delivery in early preterm preeclampsia, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Helsinki and 16 other locations
- Helsinki University Hospital — Helsinki, Finland (Not_yet_recruiting)
- Tampere University Hospital — Tampere, Finland (Recruiting)
- Akershus University Hospital — Lørenskog, Norway (Not_yet_recruiting)
- Oslo University Hospital — Oslo, Norway (Not_yet_recruiting)
- Södra Älvsborgs Hospital — Borås, Sweden (Recruiting)
- Falu Lasarett — Falun, Sweden (Recruiting)
- Sahlgrenska University Hospital — Gothenburg, Sweden (Recruiting)
- Linköping University Hospital — Linköping, Sweden (Recruiting)
- Skåne University Hospital — Lund, Sweden (Recruiting)
- Skåne University Hospital — Malmö, Sweden (Recruiting)
- Karolinska University Hospital Huddinge — Stockholm, Sweden (Recruiting)
- Karolinska University Hospital Solna — Stockholm, Sweden (Recruiting)
- Danderyd Hospital — Stockholm, Sweden (Recruiting)
- Norra Älvsborgs County Hospital — Trollhättan, Sweden (Recruiting)
- Norrland´s University Hospital — Umeå, Sweden (Recruiting)
- Uppsala University Hospital — Uppsala, Sweden (Recruiting)
- Västmanlands Hospital Västerås — Västerås, Sweden (Not_yet_recruiting)
Study contacts
- Principal investigator: Lina Bergman, Associate professor — Sahlgrenska University Hospital
- Study coordinator: Lina Bergman, Associate Professor
- Email: lina.bergman@obgyn.gu.se
- Phone: 0046-3134307
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.