Preeclampsia Intervention 4 - A Triple Blind Phase III Randomised Controlled Trial Assessing Metformin to Prolong Gestation in Preterm Preeclampsia
Status: Recruiting
Location: See all (17) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Finland
Helsinki University Hospital
NOT_YET_RECRUITING
Helsinki
Tampere University Hospital
RECRUITING
Tampere
Norway
Akershus University Hospital
NOT_YET_RECRUITING
Lørenskog
Oslo University Hospital
RECRUITING
Oslo
Sweden
Södra Älvsborgs Hospital
RECRUITING
Borås
Falu Lasarett
RECRUITING
Falun
Sahlgrenska University Hospital
RECRUITING
Gothenburg
Linköping University Hospital
RECRUITING
Linköping
Skåne University Hospital
RECRUITING
Lund
Skåne University Hospital
RECRUITING
Malmö
Danderyd Hospital
RECRUITING
Stockholm
Karolinska University Hospital Huddinge
RECRUITING
Stockholm
Karolinska University Hospital Solna
RECRUITING
Stockholm
Norra Älvsborgs County Hospital
RECRUITING
Trollhättan
Norrland´s University Hospital
RECRUITING
Umeå
Uppsala University Hospital
RECRUITING
Uppsala
Västmanlands Hospital Västerås
NOT_YET_RECRUITING
Västerås
Contact Information
Primary
Lina Bergman, Associate Professor
lina.bergman@obgyn.gu.se
0046-3134307
Backup
Pia Gudmundsson, PhD
pia.gudmundsson@obgyn.gu.se
0046-313434327
Time Frame
Start Date:2024-01-19
Estimated Completion Date:2029-12-31
Participants
Target number of participants:294
Treatments
Active_comparator: Metformin ER
Metformin ER oral tablet 500 mg three times daily and increased to one gram (two tablets) three times daily as tolerated.
Placebo_comparator: Placebo
1 placebo tablet three times daily and increased to 2 placebo tablets three times daily as tolerated.