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RECRUITING
NCT06033131
PHASE3

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

Sponsor: Lina Bergman

View on ClinicalTrials.gov

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

DRUG

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.

DRUG

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