Foetal exposure during pregnancy Trials in Disease

Study of Metformin to Extend Pregnancy Duration in Women with Preterm Preeclampsia

This trial is investigating whether metformin, a medication typically used for diabetes, can help extend pregnancy in women who develop preterm preeclampsia. Preeclampsia is a serious pregnancy complication that involves high blood pressure and signs of damage to organ systems, particularly the liver and kidneys. When this condition occurs before 32 weeks of pregnancy, it is considered preterm preeclampsia and can pose significant risks to both mother and baby.

Who can participate in this trial?

The trial is looking for pregnant women who meet the following criteria:

• Must be 18 years or older
• Must be carrying 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 been diagnosed with preeclampsia
• The medical team and patient must agree that immediate delivery is not required
• Must be able to understand English or Dutch
• Must be willing and able to provide written consent to participate

Who cannot participate in this trial?

Women will not be able to join this study if they have:

• Multiple pregnancy (carrying more than one baby)
• Known allergy or intolerance to metformin
• Pre-existing diabetes or gestational diabetes requiring medication
• Severe liver or kidney dysfunction
• Active labor with ongoing contractions and cervical changes
• HELLP syndrome, a severe form of preeclampsia involving liver problems and low platelets
• Planned delivery within 48 hours
• Evidence that the baby or mother requires immediate delivery due to serious complications
• Current participation in another clinical trial
• Age under 18 years

What does the trial involve?

Participants will receive either metformin tablets or placebo (an inactive substance) in the form of film-coated tablets taken by mouth. Neither the participant nor the healthcare provider will know which treatment is being given. The medication can be taken in doses up to 3000 mg per day for up to 98 days, and treatment continues daily until delivery or until it becomes medically necessary to end the pregnancy.

Throughout the treatment period, both the mother's health and the baby's development will be closely monitored. The medical team will regularly check blood pressure and other health indicators to ensure safety. After delivery, the mother's health will be monitored for up to 42 days, and the baby's health will be monitored for 28 days.

Investigational drug: Metformin

Metformin is a medication commonly used to treat type 2 diabetes, but in this trial it is being studied for a different purpose. Researchers are testing whether it can help extend pregnancy duration in women who develop preeclampsia before their due date. The medication 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.

Summary

Currently, only one clinical trial is actively recruiting participants for research related to foetal exposure during pregnancy complications. This trial is being conducted in the Netherlands and specifically focuses on women with preterm preeclampsia. The study is investigating metformin as a potential treatment to extend pregnancy duration in this high-risk group. The trial includes careful monitoring protocols and excludes women with the most severe complications requiring immediate delivery. This research represents an important step in finding ways to safely prolong pregnancy when preeclampsia develops early, potentially improving outcomes for both mothers and babies.