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Study on Metformin for Prolonging Pregnancy in Women with Preterm Preeclampsia

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying preeclampsia, a condition that can occur during pregnancy, characterized by high blood pressure and signs of damage to other organ systems. The study is investigating whether a medication called metformin, specifically in the form of Glucophage SR 500mg prolonged release tablet, can help prolong pregnancy in women diagnosed with preterm preeclampsia. Preterm preeclampsia refers to the condition occurring before the pregnancy reaches full term, which is typically before 37 weeks of gestation.

The purpose of the study is to determine if taking 3 grams of metformin daily can extend the duration of pregnancy in women who are managing preterm preeclampsia with expectant management, which means closely monitoring the condition without immediate delivery. Participants in the study will be randomly assigned to receive either the metformin treatment or a placebo, which is a substance with no active medication. The study will follow the participants from the time they are enrolled until they give birth, to see if the treatment helps in prolonging the pregnancy.

Throughout the study, researchers will also look at other factors such as the length of time newborns stay in neonatal care and the birth weight of the babies. The goal is to gather information that could help improve outcomes for both mothers and their babies when dealing with preterm preeclampsia. This study is expected to continue until March 2028, providing valuable insights into the potential benefits of using metformin in managing this condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will have already provided written consent to participate. This confirms your understanding and agreement to be part of the trial.
You must be 18 years or older, with a diagnosis of preeclampsia made by your attending clinician. Your pregnancy should be between 22 weeks and 33 weeks and 6 days, with a single baby and a viable fetus.
Step 2
Randomization
You will be randomly assigned to one of two groups. One group will receive the medication metformin hydrochloride, and the other group will receive a placebo, which looks like the medication but has no active ingredients.
This process is double-blind, meaning neither you nor the researchers will know which group you are in, to ensure unbiased results.
Step 3
Medication administration
If you are in the group receiving metformin hydrochloride, you will take 3 grams of the medication daily. This is provided in the form of Glucophage SR 500mg prolonged release tablets.
The medication is taken orally, which means you will swallow the tablets. The exact duration of taking the medication will depend on your individual circumstances and the progression of your pregnancy.
Step 4
Monitoring and follow-up
Throughout the trial, your health and the health of your baby will be closely monitored. This includes regular check-ups and assessments to track the progress of your pregnancy.
The primary goal is to see if the medication can help prolong your pregnancy. The time from when you start the trial to when you deliver will be recorded.
Step 5
Completion of the trial
The trial will conclude with the delivery of your baby. The length of your baby's stay in neonatal care, if needed, will also be recorded.
Your participation will help researchers understand the effects of metformin hydrochloride on preterm preeclampsia and its potential to prolong pregnancy.

Who can join the trial?

6 criteria

A diagnosis of preeclampsia has been made by the attending clinician. Preeclampsia is a condition in pregnancy characterized by high blood pressure and often a significant amount of protein in the urine.
The managing clinicians have decided to proceed with expectant management, meaning they will monitor the condition closely and delay delivery as long as it is safe, and delivery is not expected within 48 hours.
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 weeks and 33 weeks and 6 days with a viable fetus. Gestational age refers to how far along the pregnancy is.
The woman carries a singleton pregnancy, meaning she is pregnant with only one baby.

Who cannot join the trial?

4 criteria

Patients who are not diagnosed with **preeclampsia** cannot participate. Preeclampsia is a condition in pregnancy characterized by high blood pressure and often a significant amount of protein in the urine.
Patients who are not pregnant between 22 weeks and 33 weeks and 6 days cannot participate.
Patients who are not undergoing **expectant management** cannot participate. Expectant management is a medical approach where the condition is closely monitored without immediate treatment, waiting to see how it progresses.
Patients who are not female cannot participate.

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Verified sites

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Verified
Akershus University Hospital
Lorenskog, Norway
Responsive
Region Oestergoetland
Linkoping, Sweden
Responsive
Region Vaesterbotten
Umea, Sweden

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Investigated drugs

Metformin ER is a medication commonly used to manage blood sugar levels in people with type 2 diabetes. In this clinical trial, it is being tested to see if it can help prolong pregnancy in women who have preterm preeclampsia. Preeclampsia is a condition that can occur during pregnancy, characterized by high blood pressure and signs of damage to other organ systems. The trial aims to find out if taking metformin can help extend the pregnancy, giving the baby more time to develop before birth.

Metformin Hydrochloride

What is already known about the treatment

Metformin – Metformin is administered orally in the form of extended-release tablets, taken daily. It is currently being studied in a phase III clinical trial to determine its effectiveness in prolonging pregnancy in women with preterm preeclampsia. The main therapeutic indication being investigated is its potential to extend gestation in pregnancies affected by this condition. At the molecular level, metformin works by improving the body's response to insulin and reducing glucose production in the liver. It is classified as a biguanide, a type of medication commonly used to manage blood sugar levels in people with type 2 diabetes.

Investigated diseases

Preeclampsia – Preeclampsia is a pregnancy-related condition characterized by high blood pressure and often a significant amount of protein in the urine. It typically occurs after 20 weeks of gestation in women whose blood pressure had previously been normal. The disease can lead to complications for both the mother and the baby if not managed properly. Symptoms may include severe headaches, changes in vision, upper abdominal pain, and swelling in the hands and face. The condition can progress to more severe forms, such as eclampsia, which involves seizures. The exact cause of preeclampsia is not fully understood, but it is believed to involve problems with the blood vessels that supply the placenta.