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Study on the Effects of Metformin in Pregnant Women with Gestational Diabetes

Verified siteRegistered drugNo placebo

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What is this trial about?

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

The POEM Study is focused on understanding the effects of the medication metformin on gestational diabetes mellitus (GDM), a type of diabetes that occurs during pregnancy. Metformin is a medication commonly used to help control blood sugar levels by reducing insulin resistance, which is a key issue in GDM. The study aims to see if adding metformin to the usual care for GDM can improve health outcomes for both the mother and the child.

Participants in the study will be divided into two groups. One group will receive the standard care for GDM, while the other group will receive standard care plus metformin. The study will follow the participants from the time of their GDM diagnosis during pregnancy until 20 years after delivery. This long-term study is divided into three phases: during pregnancy until 6 weeks after delivery, from 6 weeks to 1 year after delivery, and from 1 to 20 years after delivery. The study will look at various health outcomes, such as the development of type 2 diabetes in mothers, weight changes in both mothers and children, and other health-related factors.

The study will also monitor several specific health outcomes during and after pregnancy, such as pregnancy-related high blood pressure, the size of the baby at birth, and the need for certain types of delivery. Additionally, it will track the health and development of the child over time, including growth, weight, and other developmental milestones. The goal is to gather comprehensive data on how metformin might benefit mothers with GDM and their children in the long run.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Phase A: Pregnancy and Early Postpartum
During this phase, the study focuses on the effects of metformin in combination with standard care for managing gestational diabetes mellitus (GDM).
Participants will take metformin hydrochloride in the form of an oral film-coated tablet with a dosage of 850 mg. The frequency and duration of administration will be determined by the study protocol.
This phase lasts from the diagnosis of GDM until 6 weeks after delivery.
The primary goal is to assess the impact of metformin on pregnancy outcomes, including the risk of pregnancy-related hypertension, large for gestational age infants, premature delivery, and other related conditions.
Step 2
Phase B: Postpartum to One Year
This phase extends from 6 weeks to 1 year after delivery.
The study continues to monitor the health of the mother and child, focusing on the development of type 2 diabetes in the mother, as well as weight changes in both the mother and child.
Participants will continue to follow the study protocol, which may include ongoing administration of metformin and regular health assessments.
Step 3
Phase C: Long-term Follow-up
This phase covers the period from 1 year to 20 years after delivery.
The study aims to evaluate long-term health outcomes, including the development of chronic diseases, growth and weight development, and other health indicators in both the mother and child.
Participants will be monitored periodically to assess these outcomes, with specific objectives and endpoints defined by the study protocol.

Who can join the trial?

7 criteria

Must be a pregnant woman diagnosed with gestational diabetes mellitus (GDM). This is a type of diabetes that occurs during pregnancy.
Have a fasting plasma glucose (FPG) level of 5.3 mmol/l or higher. This is a blood sugar test done after not eating for a while.
Have an oral glucose tolerance test (OGTT) result with a plasma glucose (PG) level of 7.8 mmol/l or higher, two hours after drinking a sugary drink. This test checks how your body processes sugar.
Must provide written informed consent, meaning you agree to participate in the study after understanding what it involves.
Be between the ages of 18 and 45 years.
Be between 16 and 34 weeks of pregnancy when joining the study.
Have an HbA1c level of 48 mmol/mol (6.5%) or lower at the time of joining. This is a blood test that shows your average blood sugar levels over the past few months.

Who cannot join the trial?

4 criteria

Individuals who do not have gestational diabetes mellitus (a type of diabetes that occurs during pregnancy) cannot participate.
Participants must be within the specified age range for the study.
Both females and males can participate, but they must meet all other criteria.
Individuals who are considered part of a vulnerable population may not be eligible.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Frisius
Verified
Heerenveen, The Netherlands
Medical Center Haaglanden
Verified
Leidschendam, The Netherlands
Stichting Martini Ziekenhuis
Verified
Groningen, The Netherlands

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Investigated drugs

Metformin is a medication used in this study to help manage gestational diabetes mellitus (GDM). It works by reducing insulin resistance, which is a key issue in GDM. The study aims to see if adding metformin to the usual care for GDM can improve health outcomes for both the mother and child. The effects of metformin are being compared to standard care alone during pregnancy and for up to 20 years after delivery.

Metformin Hydrochloride

What is already known about the treatment

Metformin – Metformin is typically administered orally in tablet form. It is a well-established medication in the medical field, widely documented in medical literature for its use in managing type 2 diabetes and, more recently, gestational diabetes mellitus (GDM). The primary therapeutic indication for metformin in this context is to improve outcomes in GDM by reducing insulin resistance, which is a key factor in the condition. At the molecular level, metformin works by decreasing glucose production in the liver and improving the body's sensitivity to insulin. It is classified pharmacologically as a biguanide, a type of medication that helps control blood sugar levels.

Investigated diseases

Gestational Diabetes Mellitus – This condition occurs during pregnancy when the body cannot produce enough insulin to meet the increased needs, leading to high blood sugar levels. It typically develops in the second or third trimester and often does not present noticeable symptoms. The condition can result in complications such as high blood pressure, large birth weight of the baby, and premature delivery. After childbirth, blood sugar levels usually return to normal, but it increases the risk of developing type 2 diabetes later in life. Monitoring and managing blood sugar levels are crucial to minimize potential complications for both the mother and the baby.