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

ConditionPreeclampsia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorLina Bergman

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Metformin ER

    Drug

    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

    Drug

    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.

Treatment groups

294 Participants
are divided into 2 treatment groups
Group A: Metformin ERActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pregnancy prolongation

Length of pregnancy from diagnosis of preeclampsia to delivery

Time frame
From randomisation to delivery, measured in days and hours, up to 105 days

Secondary outcomes

1

Time for neonatal care

Time for neonatal care from birth to discharge

Time frame
From birth to discharge from neonatal care, measured in days and hours, up to 126 days
2

Neonatal birth weight

Birth wight measured in grams

Time frame
At birth

Other outcomes

1

Occurrence of maternal death

Occurrence of maternal death

Time frame
Registered from inclusion to two month post partum
2

Occurrence of Eclampsia

Occurrence of Eclampsia

Time frame
Registered from inclusion to two month post partum
3

Occurrence of Cerebral vascular event

Occurrence of Cerebral vascular event

Time frame
Registered from inclusion to two month post partum
4

Occurrence of posterior reversible encephalopathy syndrome

Occurrence of posterior reversible encephalopathy syndrome

Time frame
Registered from inclusion to two month post partum

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lina Bergman

Lead sponsor

Sahlgrenska University Hospital

Sponsor institution

The Swedish Research Council

Collaborator

Source ClinicalTrials.gov
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