Ongoing Clinical Trials for Pre-eclampsia
Pre-eclampsia is a serious pregnancy complication characterized by high blood pressure and potential organ damage. Currently, there are 7 ongoing clinical trials investigating various preventive treatments for this condition, including aspirin, metformin, and pravastatin. These studies focus on different high-risk pregnancy groups, from women with chronic hypertension to 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 whether daily aspirin can prevent serious pregnancy complications in women who have chronic high blood pressure. The study focuses on preventing conditions such as pre-eclampsia, placental abruption, fetal growth restriction, and preterm delivery.
Who can participate: Pregnant women between 10 and 19 weeks plus 6 days of pregnancy who have chronic high blood pressure, whether treated or untreated. Participants must be carrying a single baby and have active social security coverage.
Who cannot participate: Women with known allergies to aspirin, those carrying multiple babies, individuals with bleeding disorders or peptic ulcer disease, those currently using blood-thinning medications, people with liver or kidney disease, those with platelet counts below 100,000 per microliter, and women already taking aspirin or NSAIDs regularly.
Treatment details: Participants receive either 150 mg of acetylsalicylic acid or a placebo in gastro-resistant tablet form, taken daily for 6 months during pregnancy. The tablets are specially coated to dissolve in the intestine rather than the stomach. The study is designed so that neither participants nor healthcare providers know which treatment is being given.
Study goal: The research aims to determine whether aspirin can reduce the risk of serious complications including pre-eclampsia, separation of the placenta from the womb, reduced baby growth, early delivery, and other serious health issues for both mother and baby. Long-term follow-up includes monitoring the child’s development at ages 2 and 4 years.
Study of Metformin to Extend Pregnancy Duration in Women with Preterm Preeclampsia
This trial examines whether metformin can help extend pregnancy duration in women diagnosed with preterm pre-eclampsia, which occurs before 32 weeks of pregnancy. The study also includes women with HELLP syndrome, a severe form of the condition affecting blood and liver function.
Who can participate: Women aged 18 or older with a singleton pregnancy between 23 and 31 weeks plus 6 days of gestation, where the baby weighs more than 400 grams on ultrasound. Participants must have pre-eclampsia, and the medical team and patient must agree that immediate delivery is not required. Women must understand English or Dutch and provide written informed consent.
Who cannot participate: Women carrying multiple babies, those with known allergy to metformin, individuals with pre-existing or gestational diabetes requiring medication, those with severe liver or kidney dysfunction, women in active labor, those with HELLP syndrome, women planning delivery within 48 hours, and those under 18 years of age.
Treatment details: Participants receive either metformin or placebo in film-coated tablet form, with doses up to 3000 mg per day. Treatment continues daily until delivery or until it becomes medically necessary to end the pregnancy, for up to 98 days.
Study goal: The research aims to determine if metformin can prolong pregnancy safely, allowing the baby more time to develop. The study monitors both maternal health and fetal development throughout treatment, with follow-up extending to 42 days after delivery for mothers and 28 days after birth for babies.
Study on Aspirin for Preventing Preeclampsia in First-Time Pregnant Women Using Assisted Reproductive Technology
This trial investigates whether daily aspirin can prevent preterm pre-eclampsia in first-time mothers who became pregnant through assisted reproductive technology such as IVF, ICSI, oocyte donation, or intrauterine insemination with sperm donor.
Who can participate: First-time mothers aged 18 or older with a singleton pregnancy between 9 and 14 weeks of gestation, whose pregnancy resulted from assisted reproductive technology. Participants must have French Social Security Insurance or equivalent coverage and provide written informed consent.
Who cannot participate: Women who are not pregnant, those who are not first-time mothers, women who did not use assisted reproductive technology, those not between 9 and 14 weeks of pregnancy, and women who are not at risk of developing pre-eclampsia.
Treatment details: Participants receive either 150 mg aspirin or placebo in hard capsule form, taken orally once daily. Treatment begins between 9 and 14 weeks of pregnancy and continues until the 26th week.
Study goal: The research aims to evaluate whether aspirin can prevent preterm pre-eclampsia compared to placebo. The study monitors various outcomes including the occurrence of pre-eclampsia, preterm birth, cesarean delivery, and other pregnancy complications. Researchers also assess newborn health, including birth weight and any complications. The trial includes cost-effectiveness analysis, examining hospitalizations, consultations, and other medical expenses.
Study on Aspirin for Preventing Preeclampsia in Twin Pregnancies
This trial examines whether low-dose aspirin can prevent pre-eclampsia in women expecting twins, whether dichorionic diamniotic or monochorionic diamniotic pregnancies.
Who can participate: Women over 18 years old who are pregnant with twins, with both babies alive between 11 weeks and 2 days to 13 weeks and 6 days of pregnancy. Participants must provide informed written consent.
Who cannot participate: The trial excludes individuals who do not meet the age requirement or do not have a twin pregnancy within the specified gestational window.
Treatment details: Participants receive either aspirin 75mg gastro-resistant tablets or placebo, taken orally once daily. The medication is taken from the first trimester until delivery before 37 weeks of gestation. The study is double-blind, meaning neither participants nor healthcare providers know which treatment is being given.
Study goal: The research aims to determine if low-dose aspirin reduces the incidence of preterm pre-eclampsia in twin pregnancies. Regular check-ups monitor participant health and pregnancy progress, with participants asked to report any side effects or unusual symptoms. The trial assesses both maternal and fetal safety throughout.
Study on Metformin for Prolonging Pregnancy in Women with Preterm Preeclampsia
This Swedish trial investigates whether metformin can extend pregnancy duration in women diagnosed with preterm pre-eclampsia who are being managed expectantly, meaning the condition is closely monitored without immediate delivery.
Who can participate: Women aged 18 or older with a singleton pregnancy between 22 and 33 weeks plus 6 days of gestation, with a viable fetus. The attending clinician must have diagnosed pre-eclampsia, and the managing clinicians must have decided to proceed with expectant management. Delivery should not be expected within 48 hours, and participants must provide written consent.
Who cannot participate: Women not diagnosed with pre-eclampsia, those not pregnant between 22 and 33 weeks plus 6 days, and those not undergoing expectant management.
Treatment details: Participants receive either 3 grams of metformin hydrochloride daily in the form of Glucophage SR 500mg prolonged release tablets, or placebo. The study is double-blind, with neither participants nor researchers knowing which group participants are in. Medication is taken orally throughout the remainder of pregnancy.
Study goal: The research aims to determine if metformin can help prolong pregnancy in women with preterm pre-eclampsia. Throughout the trial, both maternal and fetal health are closely monitored with regular check-ups and assessments. The primary goal is to measure the time from trial enrollment to delivery, as well as tracking the length of neonatal care stays if needed.
Study on Pravastatin for Pregnant Patients with Preeclampsia or Intrauterine Growth Restriction
This Spanish trial investigates whether pravastatin, a medication commonly used to lower cholesterol, can help manage severe early-onset pre-eclampsia or intrauterine growth restriction in pregnancy.
Who can participate: Women with a singleton pregnancy between 24 and 29 weeks plus 6 days of gestation who have a diagnosis of severe early-onset pre-eclampsia not requiring immediate delivery, and/or intrauterine growth restriction with specific blood flow issues in the umbilical cord. Participants must be able to give informed consent.
Who cannot participate: Non-pregnant individuals, males, those outside the 24 to 29 weeks plus 6 days gestational window, and individuals with conditions other than intrauterine growth restriction or pre-eclampsia.
Treatment details: Participants are randomly assigned to receive either a 40 mg pravastatin tablet or placebo, taken orally once daily from enrollment until delivery.
Study goal: The research aims to determine if taking 40 mg of pravastatin daily can prolong pregnancy in women diagnosed with these serious conditions. Throughout the trial, regular monitoring includes physical examinations, blood tests, and ultrasound scans to track maternal health and pregnancy progress. The primary endpoint is the number of days the pregnancy is prolonged from inclusion until delivery.
Study on Low Dose Acetylsalicylic Acid to Prevent Preeclampsia in Pregnant Women After Frozen Embryo Transfer
This Belgian trial examines whether low-dose aspirin can prevent pre-eclampsia in women who have undergone frozen embryo transfer as part of fertility treatment.
Who can participate: Healthy women aged 18 to 43 who are planning frozen embryo transfer using a natural cycle, modified natural cycle, or hormone replacement therapy cycle. Participants must have given informed consent and have confirmed pregnancy at week 6 of amenorrhea following the transfer.
Who cannot participate: Women not planning frozen embryo transfer, those outside the specified age range, women unwilling to take the study medication, those with medical conditions making participation unsafe, women already taking interfering medications, those with allergic reactions to aspirin, individuals with bleeding disorders, and women with severe liver or kidney disease.
Treatment details: Participants are randomly assigned to receive either 160 mg of acetylsalicylic acid or no treatment. The medication is administered orally in gastro-resistant tablet form to prevent stomach irritation, continuing throughout pregnancy.
Study goal: The research aims to determine if low-dose acetylsalicylic acid can reduce the occurrence of pre-eclampsia in this specific population. The study monitors participants for development of pre-eclampsia, comparing the number of women who develop the condition in the treated group versus the untreated group. The trial is expected to conclude by October 2025.
Summary
The current landscape of clinical trials for pre-eclampsia shows a strong focus on prevention strategies, particularly using aspirin at various doses. Of the seven ongoing trials, four investigate aspirin as the primary intervention, highlighting its established role in pre-eclampsia prevention. Two trials explore metformin, traditionally a diabetes medication, for its potential to prolong pregnancy in women who have already developed preterm pre-eclampsia. One innovative trial examines pravastatin, a cholesterol-lowering medication, for managing severe early-onset cases.
Geographically, these trials are distributed across Europe, with notable activity in Spain, France, and Belgium. One trial spans multiple countries including Spain, Belgium, Austria, Greece, Denmark, and Czechia, reflecting international collaboration. The trials target diverse high-risk populations, from women with chronic hypertension and twin pregnancies to those using assisted reproductive technology, demonstrating efforts to address pre-eclampsia prevention across various pregnancy scenarios.
Most studies focus on prevention in the first and second trimesters, while the metformin trials specifically target women who have already developed preterm pre-eclampsia, aiming to safely extend pregnancy duration. This dual approach of prevention and management reflects the complexity of addressing this serious pregnancy complication.