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Study of Metformin to Extend Pregnancy Duration 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 investigates the use of metformin in pregnant individuals with preterm preeclampsia. Preeclampsia is a pregnancy complication characterized by high blood pressure and signs of damage to organ systems, particularly the liver and kidneys. When it occurs before 32 weeks of pregnancy, it is called preterm preeclampsia. The study also includes patients with HELLP syndrome, a severe form of preeclampsia that affects the blood and liver, and other hypertensive disorders of pregnancy.

The study aims to determine if metformin can help extend pregnancy duration in individuals with preterm preeclampsia. Participants will receive either metformin tablets or placebo. The medication will be given as film-coated tablets for oral use, with doses up to 3000 mg per day for up to 98 days.

The treatment involves taking the study medication daily until delivery or until it becomes necessary to end the pregnancy for medical reasons. The study will monitor both the mother's health and the baby's development throughout the treatment period. The medication will be provided in a modified form (overencapsulated) to ensure that neither the participant nor the healthcare provider knows whether they are receiving metformin or placebo.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial medication phase

    You will receive metformin or a placebo (inactive substance) in the form of film-coated tablets for oral use

    The treatment begins between week 23 and week 31+6 days of pregnancy

    The medication will be administered when you are diagnosed with preterm preeclampsia (high blood pressure during pregnancy)

  2. Step 2

    Monitoring period during pregnancy

    Your pregnancy will be closely monitored to ensure both your and your baby's safety

    Regular checks will be performed to monitor your blood pressure and other health indicators

    The medical team will track how many additional days your pregnancy continues after starting the medication

  3. Step 3

    Birth and immediate post-birth period

    The medical team will monitor the birth process

    Your health status will be checked during delivery and immediately after

    Your baby's health will be assessed at birth

  4. Step 4

    Follow-up period

    Your health status will be monitored for up to 42 days after delivery

    Your baby's health will be monitored for 28 days after birth

    The medical team will assess various aspects of both your and your baby's health during this period

Who can join the trial?

8 criteria

  • Must be 18 years or older
  • Must be pregnant with only one baby (singleton pregnancy)
  • Must be between 23 weeks and 31 weeks plus 6 days of pregnancy
  • The baby must weigh more than 400 grams based on ultrasound estimates
  • Must have preeclampsia (a pregnancy condition involving high blood pressure and signs of damage to other organ systems)
  • The medical team and patient must agree that immediate delivery is not required
  • Must be able to understand English or Dutch language
  • Must be willing and able to provide written informed consent (formal agreement to participate in the study)

Who cannot join the trial?

15 criteria

  • Multiple pregnancy (carrying more than one baby)
  • Known allergy or intolerance to metformin
  • Pre-existing diabetes or gestational diabetes requiring medication
  • Severe liver dysfunction (poor liver function)
  • Severe kidney dysfunction (poor kidney function)
  • Active labor (ongoing contractions with cervical changes)
  • HELLP syndrome (a severe form of preeclampsia involving liver problems and low platelets)
  • Planned delivery within 48 hours
  • Current participation in another clinical trial
  • Inability to provide informed consent
  • Chronic medical conditions requiring ongoing treatment
  • History of adverse reactions to similar medications
  • Evidence of fetal compromise requiring immediate delivery
  • Severe maternal complications requiring immediate delivery
  • Age under 18 years
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Investigated drugs

Metformin is a medication commonly used to treat type 2 diabetes, but in this trial, it is being studied for a different purpose. It's being tested to see if it can help extend pregnancy duration in women who develop preeclampsia (high blood pressure during pregnancy) before their due date. The medication is taken orally and works by improving how the body handles insulin and reduces inflammation, which might help manage preeclampsia symptoms and allow the pregnancy to continue safely for a longer time.

What is already known about the treatment

Metformin – An oral antidiabetic medication that is being investigated for its potential use in preterm preeclampsia and HELLP syndrome during pregnancy. The drug works by reducing insulin resistance and glucose production in the liver while improving the body's sensitivity to insulin at the cellular level. Traditionally used as a first-line treatment for type 2 diabetes, metformin is now being studied for its potential benefits in prolonging pregnancy in women with preeclampsia, as it may help improve placental function and reduce inflammation. This medication belongs to the biguanide class of drugs and is typically administered in tablet form, with dosing determined based on individual patient factors and medical condition severity.

Investigated diseases

  • HELLP syndrome

    A serious pregnancy complication characterized by the breakdown of red blood cells, elevated liver enzymes, and low platelet count. It typically develops in the later stages of pregnancy or right after childbirth. The condition is considered a variant of preeclampsia and affects the mother's blood and liver function.

  • Preterm preeclampsia

    A pregnancy-related condition that occurs before 37 weeks of pregnancy, characterized by high blood pressure and signs of damage to organ systems. It involves abnormal blood flow to the placenta and can affect multiple organs. The condition typically begins with elevated blood pressure and protein in the urine.

  • Hypertensive disorders of pregnancy

    A group of conditions marked by high blood pressure during pregnancy, which can occur before, during, or after pregnancy. These disorders include chronic hypertension, gestational hypertension, and preeclampsia. The condition can develop gradually or appear suddenly during pregnancy.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-510382-10-00Protocol codeU1111-1303-8616Estimated enrolment180 patientsSponsorAmsterdam UMC Stichting

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