Ongoing Clinical Trials for Pre-eclampsia
This article provides information about 7 ongoing clinical trials focused on preventing and managing pre-eclampsia, a serious pregnancy complication characterized by high blood pressure. The trials investigate medications including aspirin (acetylsalicylic acid), metformin, and pravastatin in various pregnancy scenarios including women with chronic hypertension, twin pregnancies, and those undergoing assisted reproductive technology.
Clinical trial locations
- Austria
- Belgium
- Czechia
- Denmark
- France
- Greece
- Netherlands
- Spain
- Sweden
Study of Acetylsalicylic Acid (Aspirin) 150 mg for Prevention of Complications in Pregnant Women with Chronic Hypertension
This trial is investigating the use of aspirin to prevent serious pregnancy complications in women who have chronic high blood pressure. The research focuses on whether taking 150 mg of aspirin daily can reduce the risk of developing pre-eclampsia, problems with the baby’s growth, early separation of the placenta, and early delivery.
Main inclusion criteria: Women must be between 10 and 19 weeks and 6 days pregnant with a single baby and have chronic high blood pressure (whether treated or untreated). Participants must be willing to provide written consent and have active social security coverage.
Main exclusion criteria: Women cannot participate if they have a known allergy to aspirin, are carrying multiple babies, have bleeding disorders, active stomach ulcers, are currently using blood-thinning medications, have severe liver or kidney disease, or are already taking aspirin or similar medications regularly. Those with very low platelet counts (less than 100,000 per microliter) are also excluded.
Focus and goals: The study examines how aspirin affects pregnancy-related complications including pre-eclampsia, fetal growth restriction, and other blood pressure problems during pregnancy. Participants will receive either aspirin tablets or placebo for 6 months during pregnancy. The trial will monitor various conditions throughout pregnancy and follow children’s development until they reach 4 years of age.
Investigational drug: Acetylsalicylic acid (aspirin) is being studied for its potential benefits in pregnant women with chronic high blood pressure. The medication works by preventing the formation of substances that cause inflammation and blood clotting. When used during pregnancy, it may help prevent serious complications by improving blood flow to the placenta.
Study of Metformin to Extend Pregnancy Duration in Women with Preterm Preeclampsia
This trial investigates whether metformin can help extend pregnancy duration in women who develop pre-eclampsia before 32 weeks of pregnancy. The study also includes patients with HELLP syndrome, a severe form of pre-eclampsia that affects the blood and liver.
Main inclusion criteria: Women must be 18 years or older, pregnant with only one baby, between 23 and 31 weeks plus 6 days of pregnancy, with the baby weighing more than 400 grams based on ultrasound. They must have pre-eclampsia and both the medical team and patient must agree that immediate delivery is not required. Participants must understand English or Dutch and be willing to provide written consent.
Main exclusion criteria: Women cannot participate if they are carrying multiple babies, have a known allergy to metformin, have pre-existing or gestational diabetes requiring medication, severe liver or kidney dysfunction, are in active labor, have HELLP syndrome, or have planned delivery within 48 hours. Those unable to provide consent or with chronic medical conditions requiring ongoing treatment are also excluded.
Focus and goals: The study aims to determine if metformin can help extend pregnancy duration in individuals with preterm pre-eclampsia. Participants will receive either metformin tablets (up to 3000 mg per day) or placebo for up to 98 days. The trial will monitor both mother’s health and baby’s development throughout treatment, continuing follow-up for 42 days after delivery for mothers and 28 days for babies.
Investigational drug: Metformin, commonly used to treat type 2 diabetes, is being tested to see if it can help extend pregnancy duration in women who develop pre-eclampsia before their due date. The medication works by improving how the body handles insulin and reducing inflammation, which might help manage symptoms and allow pregnancy to continue safely for longer.
Study on Aspirin for Preventing Preeclampsia in First-Time Pregnant Women Using Assisted Reproductive Technology
This trial focuses on preventing pre-eclampsia in women who are pregnant for the first time after using assisted reproductive technology, such as in vitro fertilization. The study investigates whether taking 150 mg of aspirin daily can prevent preterm pre-eclampsia, which occurs when the condition develops before 37 weeks of pregnancy.
Main inclusion criteria: Women must be 18 years or older and have never given birth before. Pregnancy must have occurred following assisted reproductive technology (including IVF, ICSI, egg donation, or intrauterine insemination with sperm donor) and be a single baby pregnancy between 9 and 14 weeks of gestation. Participants must have French Social Security Insurance or equivalent coverage and provide written informed consent.
Main exclusion criteria: The trial excludes women who are not pregnant, not in their first pregnancy, did not use assisted reproductive technology, are not between 9 and 14 weeks pregnant, or are not at risk of developing pre-eclampsia. Women unwilling to take aspirin or placebo daily cannot participate.
Focus and goals: Participants will begin taking aspirin between 9 and 14 weeks of pregnancy and continue until the 26th week. The study will monitor the occurrence of pre-eclampsia, preterm birth, cesarean delivery, and other pregnancy-related complications. The trial will also track newborn health, including birth weight and any complications after birth, and will assess treatment cost-effectiveness.
Investigational drug: Aspirin is being tested for its potential to lower the risk of developing pre-eclampsia in women pregnant for the first time after assisted reproductive technology. The medication can help improve blood flow to the placenta and reduce inflammation during pregnancy.
Study on Aspirin for Preventing Preeclampsia in Twin Pregnancies
This international trial is investigating whether taking a low dose of aspirin (75 mg) can prevent pre-eclampsia in women expecting twins. The study is being conducted across multiple countries including Spain, Belgium, Austria, Greece, Denmark, and Czechia.
Main inclusion criteria: Women must be over 18 years old and pregnant with twins (either dichorionic diamniotic or monochorionic diamniotic). Both babies must be alive between 11 weeks and 2 days to 13 weeks and 6 days of pregnancy. Participants must provide informed and written consent.
Main exclusion criteria: The trial does not specify detailed exclusion criteria beyond stating that participants must be female and within the specified age range.
Focus and goals: The trial aims to determine if taking 75 mg of aspirin daily can reduce the chances of developing pre-eclampsia before 37 weeks of pregnancy. Participants will be randomly assigned to receive either aspirin or placebo tablets from the first trimester until delivery. The study is designed to be double-blind, meaning neither participants nor researchers will know who is receiving aspirin during the trial period.
Investigational drug: Aspirin 75 mg gastro-resistant tablets are being tested to see if they can help prevent pre-eclampsia in women pregnant with twins. The tablets are specially coated to dissolve in the intestine rather than the stomach.
Study on Metformin for Prolonging Pregnancy in Women with Preterm Preeclampsia
This Swedish trial investigates whether metformin, specifically Glucophage SR 500mg prolonged release tablets, can help prolong pregnancy in women diagnosed with preterm pre-eclampsia. The study focuses on women who are managing the condition with expectant management, meaning close monitoring without immediate delivery.
Main inclusion criteria: Women must be 18 years or older with a diagnosis of pre-eclampsia made by their attending clinician. Pregnancy must be between 22 weeks and 33 weeks and 6 days with a single baby and viable fetus. Managing clinicians must have decided to proceed with expectant management, and delivery must not be expected within 48 hours. Participants must give written consent.
Main exclusion criteria: Women cannot participate if they are not diagnosed with pre-eclampsia, are not pregnant between 22 and 33 weeks and 6 days, or are not undergoing expectant management.
Focus and goals: The study aims to determine if taking 3 grams of metformin daily can extend pregnancy duration in women managing preterm pre-eclampsia with expectant management. Participants will be randomly assigned to receive either metformin treatment or placebo. Throughout the trial, health of both mother and baby will be closely monitored with regular check-ups and assessments.
Investigational drug: Metformin ER (extended-release) is being tested to see if it can help prolong pregnancy in women with preterm pre-eclampsia. The medication works by improving the body’s response to insulin and reducing glucose production in the liver, which may help extend gestation in affected pregnancies.
Study on Pravastatin for Pregnant Patients with Preeclampsia or Intrauterine Growth Restriction
This Spanish trial focuses on two pregnancy-related conditions: pre-eclampsia and intrauterine growth restriction, where the baby grows slower than expected in the womb. The study tests whether pravastatin, commonly used to lower cholesterol, can help manage these conditions during pregnancy.
Main inclusion criteria: Women must be pregnant with a single baby between 24 weeks and 29 weeks and 6 days. They must have early-onset severe pre-eclampsia (high blood pressure and other symptoms, but not requiring immediate delivery according to doctor’s assessment) and/or intrauterine growth restriction (baby smaller than expected with specific blood flow issues in the umbilical cord). Participants must be able to give informed consent.
Main exclusion criteria: Individuals who are not pregnant cannot participate. The trial excludes those with conditions other than intrauterine growth restriction or pre-eclampsia. Participants must not belong to vulnerable population groups not specified in the trial.
Focus and goals: The study determines if taking 40 mg of pravastatin daily can help prolong pregnancy in women diagnosed with severe early-onset pre-eclampsia or growth restriction between 24 and 29 weeks of gestation. Participants will be randomly assigned to receive either pravastatin or placebo. The trial monitors pregnancy duration from inclusion until delivery.
Investigational drug: Pravastatin, usually used to lower cholesterol levels, is being tested to see if it can help prolong pregnancy in women with placental insufficiency. The medication works by inhibiting an enzyme involved in cholesterol production, which may improve blood flow to the placenta.
Study on Low Dose Acetylsalicylic Acid to Prevent Preeclampsia in Pregnant Women After Frozen Embryo Transfer
This Belgian trial investigates the use of low-dose aspirin (160 mg) as a preventive treatment for pre-eclampsia in pregnant women who have undergone frozen embryo transfer as part of fertility treatment.
Main inclusion criteria: Healthy women must be aged between 18 and 43 years old and planning to have a frozen embryo transfer. They must be using a natural cycle, modified natural cycle, or hormone replacement therapy cycle for the embryo transfer. Participants must have given informed consent and have a confirmed pregnancy at week 6 of amenorrhea (6 weeks pregnant).
Main exclusion criteria: Women who are not planning frozen embryo transfer, not in the specified age range, or unwilling to take the study medication cannot participate. Those with medical conditions deemed unsafe by study doctors, already taking interfering medications, having bleeding disorders, severe liver or kidney disease, or history of allergic reactions to aspirin are excluded. Women participating in another clinical trial simultaneously are also excluded.
Focus and goals: The study determines if taking low-dose acetylsalicylic acid can reduce the occurrence of pre-eclampsia in women who have undergone frozen embryo transfer. Participants will be randomly assigned to either receive 160 mg of aspirin or no treatment. The study monitors participants throughout pregnancy to compare how many women in each group develop pre-eclampsia.
Investigational drug: Acetylsalicylic acid (aspirin) is being studied as a preventive treatment for pre-eclampsia in pregnant women who have undergone frozen embryo transfer. The medication is administered as a gastro-resistant tablet (protecting the stomach) to prevent irritation.
Summary
These 7 clinical trials reflect a comprehensive research effort to prevent and manage pre-eclampsia across different pregnancy scenarios. The trials are distributed across 9 European countries, with notable concentration in Belgium and Spain, each hosting multiple studies. France also hosts two significant trials focusing on different at-risk populations.
The majority of trials (5 out of 7) investigate aspirin (acetylsalicylic acid) at various doses ranging from 75 mg to 160 mg, highlighting the medication’s central role in pre-eclampsia prevention research. Two trials focus on metformin’s potential to prolong pregnancy when pre-eclampsia has already developed, representing an alternative therapeutic approach. One trial uniquely explores pravastatin, traditionally a cholesterol-lowering medication, for managing severe early-onset conditions.
The research addresses diverse patient populations including women with chronic hypertension, twin pregnancies, first-time mothers using assisted reproductive technology, and those experiencing preterm pre-eclampsia. This variety demonstrates the medical community’s recognition that different pregnancy circumstances may require tailored preventive strategies. The trials generally follow rigorous double-blind, placebo-controlled designs to ensure reliable results that can inform future clinical guidelines for managing this serious pregnancy complication.
