Ongoing Clinical Trials for Foetal Growth Restriction
Four clinical trials are currently investigating different approaches to managing foetal growth restriction, a condition where babies do not grow as expected during pregnancy. These studies are taking place in France, Portugal, and Spain, examining treatments ranging from aspirin and blood-thinning medications to methods of inducing labor and advanced imaging techniques. (Also known as: Fetal Growth Restriction, Intrauterine Growth Restriction)
Clinical trial locations
- France
- Portugal
- Spain
Study of Acetylsalicylic Acid (Aspirin) 150 mg for Prevention of Complications in Pregnant Women with Chronic Hypertension
This trial is examining how aspirin can help prevent serious pregnancy complications in women with chronic high blood pressure, including the risk of their babies developing growth restriction.
Who can participate: Women who are between 10 and 19 weeks plus 6 days pregnant with a single baby and have chronic high blood pressure, whether treated or untreated. Participants must be able to provide written consent and have active social security coverage.
Who cannot participate: Women with known allergies to aspirin or similar medications, multiple pregnancies, bleeding disorders, active stomach or intestinal ulcers, liver disease with abnormal blood clotting, severe kidney disease, or those currently taking blood-thinning medications. Women with platelet counts below 100,000 per microliter of blood or those already taking aspirin or non-steroidal anti-inflammatory drugs regularly are also excluded.
Study focus: The trial compares the effects of taking 150 mg of aspirin daily versus a placebo tablet to prevent serious complications such as pre-eclampsia, placental separation, reduced baby growth, early delivery, and other health issues affecting both mother and baby. The medication is provided in gastro-resistant tablets that dissolve in the intestine rather than the stomach. Neither participants nor healthcare providers know which treatment is being received during the study period. Treatment continues for 6 months during pregnancy, with long-term follow-up of children at ages 2 and 4 years.
Investigational drug: Aspirin works by preventing the formation of substances that cause inflammation and blood clotting. During pregnancy, it may help prevent complications by improving blood flow to the placenta and reducing the risk of blood clots.
Study on Placental Blood Flow in Fetal Growth Restriction Using Sulfur Hexafluoride for Patients Undergoing Medical Termination of Pregnancy
This study uses a special imaging technique to examine blood flow in the placenta of pregnancies affected by growth restriction. The research takes place in women who have already decided to undergo medical termination of pregnancy.
Who can participate: Adult women at least 18 years old with a singleton pregnancy between 16 and 38 weeks and 6 days who have requested medical termination of pregnancy and had this request accepted in writing by a medical center. For the growth restriction group, the baby must have severe growth restriction with estimated weight below the 3rd percentile, confirmed by ultrasound within 15 days before the termination request.
Who cannot participate: Men, women outside the specified pregnancy timeframe, those who are part of vulnerable populations requiring special protection, or women with medical conditions that could interfere with the study.
Study focus: The trial uses contrast-enhanced ultrasound with sulfur hexafluoride, a gas that helps improve ultrasound images. This contrast agent is injected intravenously, and then detailed ultrasound images are taken to examine placental blood flow. Researchers compare the blood flow patterns between women with growth restriction and those without to better understand how the condition affects placental circulation. Placental samples are collected afterward for microscopic analysis and to study how the contrast agent deposits in the placenta tissue.
Investigational approach: Contrast-enhanced ultrasound uses a contrast agent injected into the bloodstream to enhance the visibility of blood flow and tissue structures. The contrast agent increases the reflection of ultrasound waves, improving the clarity and detail of images showing fetal-placental circulation.
Study of Enoxaparin Treatment in Pregnant Women with Early Fetal Growth Restriction
This study is investigating whether enoxaparin, a blood-thinning medication, can help extend the time babies with growth restriction can remain in the womb before delivery becomes necessary.
Who can participate: Women 18 years or older who are pregnant with a single baby and have a confirmed diagnosis of early growth restriction. Participants must be able to understand and provide informed consent, and the pregnancy must be viable with the diagnosis confirmed at the study facility according to current medical standards.
Who cannot participate: Women with active or recent significant bleeding within the last month, blood clotting disorders that increase bleeding risk, known allergies to enoxaparin or similar medications, severe kidney disease, current use of other blood-thinning medications, multiple pregnancies, placental abruption, active liver disease, history of heparin-induced thrombocytopenia, planned delivery within the next week, participation in another clinical trial within the past 30 days, or those unable to comply with study procedures or follow-up visits.
Study focus: Participants receive daily injections of enoxaparin sodium (4,000 international units or 40 mg) under the skin for up to 24 weeks during pregnancy. The study monitors various aspects of both mother’s and baby’s health through regular check-ups, including blood flow to the baby and through the placenta, tracking the baby’s growth, and monitoring maternal health. Important outcomes include the baby’s birth weight, overall health at birth, and any complications during pregnancy or delivery. After delivery, the need for intensive care for the baby, maternal recovery, and placental examination are also assessed.
Investigational drug: Enoxaparin is a low molecular weight heparin that helps prevent blood clots by making the blood less likely to clot. In this trial, it is being studied for its potential to improve blood flow to the developing baby through the placenta, which may help improve growth during pregnancy.
Study Comparing Cook’s Balloon and Dinoprostone for Inducing Labor in Pregnant Women with Fetal Growth Restriction at Term
This trial compares two methods of inducing labor in pregnancies affected by growth restriction that have reached at least 37 weeks of pregnancy.
Who can participate: Women at least 18 years old who are pregnant with only one baby in a head-down position, with pregnancy at least 37 weeks along as confirmed by first trimester ultrasound. Participants must have Stage I intrauterine growth restriction, meaning the baby’s estimated weight is either less than the 3rd percentile or less than the 10th percentile with additional signs like high blood flow resistance in the umbilical artery or low blood flow to the baby’s brain. The Bishop score must be less than 7, the amniotic sac must be intact, and there should be no history of cesarean section or medical reasons preventing vaginal delivery or labor induction.
Who cannot participate: Women with other medical conditions that might interfere with the study, known allergies to study medications, pregnancy complications unrelated to growth restriction, history of previous uterine surgery such as cesarean section, infections that could affect pregnancy or study results, participation in another clinical trial simultaneously, conditions requiring immediate delivery, placenta previa, severe health conditions posing risks during the study, or history of drug or alcohol abuse.
Study focus: Participants are allocated to receive either Cook’s balloon or dinoprostone for cervical ripening and labor induction. The study monitors the progress of labor and compares which method is more effective in achieving vaginal delivery while keeping complications for the newborn low. Continuous monitoring of mother and fetus ensures safety throughout the labor induction process.
Investigational approaches: Cook’s Balloon is a medical device inserted into the cervix and inflated to gently open and soften the cervix, preparing it for labor. Dinoprostone is a medication that mimics natural prostaglandins to soften and dilate the cervix. It is administered as a vaginal insert containing 10 mg of the active substance.
Summary
These four clinical trials represent different approaches to managing foetal growth restriction at various stages of pregnancy. Two trials are taking place in France, with one in Portugal and one in Spain. The French studies include a prevention trial using aspirin in women with chronic hypertension and an imaging study examining placental blood flow. The Portuguese trial focuses on treatment with enoxaparin during pregnancy, while the Spanish study compares methods of inducing labor when pregnancies reach term.
The trials examine both preventive strategies, such as aspirin for high-risk pregnancies, and treatment approaches, including blood-thinning medications and labor induction methods. The studies also reflect different stages of managing the condition, from prevention and early treatment to delivery planning. Each trial contributes unique insights into understanding and managing this pregnancy complication, with monitoring periods ranging from the intervention period through delivery and, in one case, extending to early childhood follow-up.
