Actively Recruiting
PI4 - A Trial Assessing Metformin to Prolong Gestation in Preterm Preeclampsia
Led by Lina Bergman · Updated on 2026-05-04
294
Participants Needed
17
Research Sites
310 weeks
Total Duration
On this page
Sponsors
L
Lina Bergman
Lead Sponsor
T
The Swedish Research Council
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PI4 - A Trial Assessing Metformin to Prolong Gestation in Preterm Preeclampsia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with preeclampsia confirmed by hypertension and significant proteinuria
- Planning to manage preeclampsia expectantly as assessed by clinicians
- Provided written consent to participate
- Female aged 18 years or older
- Gestational age between 22+0 and 33+6 weeks with a viable single fetus
- Carrying a singleton pregnancy
You will not qualify if you...
- Any contraindications to metformin treatment
- Immediate need for delivery according to preeclampsia guidelines
- Diagnosis of Type 1 Diabetes Mellitus
- Current metformin use
- Known or suspected allergy to metformin
- Difficulty understanding study participation due to language or other issues
- Unable to provide informed consent
- Previous participation in this study
- Fetal compromise requiring imminent delivery
- Suspicion of major fetal anomaly or malformation
- Renal disease indicated by creatinine ≥125 µmol/L or rapidly declining function
- Known acute or chronic metabolic acidosis including diabetic ketoacidosis
- Deemed unsuitable for inclusion by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
Helsinki University Hospital
Helsinki, Finland, 00290
Not Yet Recruiting
2
Tampere University Hospital
Tampere, Finland, 33520
Actively Recruiting
3
Akershus University Hospital
Lørenskog, Norway, N-1474
Not Yet Recruiting
4
Oslo University Hospital
Oslo, Norway, 0372
Not Yet Recruiting
5
Södra Älvsborgs Hospital
Borås, Sweden, 50455
Actively Recruiting
6
Falu Lasarett
Falun, Sweden, 79129
Actively Recruiting
7
Sahlgrenska University Hospital
Gothenburg, Sweden, 416 85
Actively Recruiting
8
Linköping University Hospital
Linköping, Sweden, 581 85
Actively Recruiting
9
Skåne University Hospital
Lund, Sweden, 221 85
Actively Recruiting
10
Skåne University Hospital
Malmö, Sweden, 205 02
Actively Recruiting
11
Karolinska University Hospital Huddinge
Stockholm, Sweden, 14157
Actively Recruiting
12
Karolinska University Hospital Solna
Stockholm, Sweden, 17176
Actively Recruiting
13
Danderyd Hospital
Stockholm, Sweden, 182 88
Actively Recruiting
14
Norra Älvsborgs County Hospital
Trollhättan, Sweden, 461 74
Actively Recruiting
15
Norrland´s University Hospital
Umeå, Sweden, 901 85
Actively Recruiting
16
Uppsala University Hospital
Uppsala, Sweden, 75237
Actively Recruiting
17
Västmanlands Hospital Västerås
Västerås, Sweden, 72335
Not Yet Recruiting
Research Team
L
Lina Bergman, Associate Professor
CONTACT
P
Pia Gudmundsson, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here