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PI4 - A Trial Assessing Metformin to Prolong Gestation in Preterm Preeclampsia
Sponsor: Lina Bergman
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. 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.
Official title: Preeclampsia Intervention 4 - A Triple Blind Phase III Randomised Controlled Trial Assessing Metformin to Prolong Gestation in Preterm Preeclampsia
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
294
Start Date
2024-01-19
Completion Date
2029-07-31
Last Updated
2026-04-07
Healthy Volunteers
No
Conditions
Interventions
Metformin ER
Metformin ER, one gram three times daily taken orally. Once the participants have been recruited, they will start by taking one 500 mg tablet three times a day. If well tolerated it will be increased day two to a maximum of two tablets three times a day. Treatment will continue until delivery. If there are side effects that are not tolerable, the dose will be decreased and the participant will remain blinded. Each participant will keep a treatment diary and number of tablets taken will be documented by the participant or hospital staff. The study will not alter or interfere with treatment or care routinely given for preterm preeclampsia.
Placebo
Placebo, two tablets three times daily taken orally. Once the participants have been recruited, they will start by taking one tablet three times a day. If well tolerated it will be increased day two to a maximum of two tablets three times a day. Treatment will continue until delivery. If there are side effects that are not tolerable, the dose will be decreased and the participant will remain blinded. Each participant will keep a treatment diary and number of tablets taken will be documented by the participant or hospital staff. The study will not alter or interfere with treatment or care routinely given for preterm preeclampsia.
Locations (17)
Helsinki University Hospital
Helsinki, Finland
Tampere University Hospital
Tampere, Finland
Akershus University Hospital
Lørenskog, Norway
Oslo University Hospital
Oslo, Norway
Södra Älvsborgs Hospital
Borås, Sweden
Falu Lasarett
Falun, Sweden
Sahlgrenska University Hospital
Gothenburg, Sweden
Linköping University Hospital
Linköping, Sweden
Skåne University Hospital
Lund, Sweden
Skåne University Hospital
Malmo, Sweden
Karolinska University Hospital Huddinge
Stockholm, Sweden
Karolinska University Hospital Solna
Stockholm, Sweden
Danderyd Hospital
Stockholm, Sweden
Norra Älvsborgs County Hospital
Trollhättan, Sweden
Norrland´s University Hospital
Umeå, Sweden
Uppsala University Hospital
Uppsala, Sweden
Västmanlands Hospital Västerås
Västerås, Sweden