Study on Placental Blood Flow in Fetal Growth Restriction Using Sulfur Hexafluoride for Patients Undergoing Medical Termination of Pregnancy

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What is this study about?

This clinical trial is focused on studying fetal growth restriction, a condition where a baby does not grow as expected in the womb. The study will use a special imaging technique called contrast-enhanced ultrasound (CES) to examine the blood flow in the placenta, which is the organ that provides nutrients and oxygen to the baby during pregnancy. The treatment involves using a contrast agent called sulfur hexafluoride, which is a type of gas that helps improve the images taken during the ultrasound.

The purpose of the study is to compare the placental blood flow in two groups of pregnant women: those with fetal growth restriction and those without. Participants will receive an injection of the contrast agent, and then an ultrasound will be performed to capture detailed images of the placenta. This will help researchers understand how blood flow differs between the two groups and may provide insights into the causes of fetal growth restriction.

The study will involve a series of ultrasound examinations and the collection of placental samples for further analysis. These samples will be used to study the presence of sulfur hexafluoride in the placenta and to examine the structure of the placenta under a microscope. The study aims to gather valuable information that could lead to better understanding and management of fetal growth restriction in the future.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, gestational age, and pregnancy type.

The study involves adult women with a singleton pregnancy between 16 and 38 weeks of gestation who have requested a medical termination of pregnancy.

2 preparation for ultrasound

Before the ultrasound, a contrast agent called sulfur hexafluoride is prepared. This agent is used to enhance the ultrasound images.

The contrast agent is administered through an intravenous infusion.

3 contrast-enhanced ultrasound

A contrast-enhanced ultrasound (CES) is performed to study the placental vascularization.

The ultrasound aims to compare the placental blood flow in cases of fetal growth restriction with those without such restriction.

4 data collection

During the ultrasound, data on the perfusion kinetics of the contrast agent is collected.

This data helps in understanding the blood flow characteristics in the placenta.

5 placental sample collection

After the ultrasound, placental samples are obtained for further analysis.

These samples are used to study the deposition of sulfur hexafluoride in the placenta using advanced microscopy techniques.

6 end of participation

The study concludes with the collection of all necessary data and samples.

The information gathered contributes to understanding placental vascularization in different conditions.

Who Can Join the Study?

Must be an adult woman, which means you need to be at least 18 years old.
Your pregnancy should be between 16 weeks and 38 weeks and 6 days.
You should be pregnant with only one baby, not twins or more.
You must have requested a medical termination of pregnancy, and this request should be accepted in writing by a specific medical center.
If you are in the “growth restriction” group, your baby must have severe growth restriction. This means the baby’s estimated weight is below the 3rd percentile, determined by an ultrasound done within 15 days before the termination request.

Who Cannot Join the Study?

Participants must not have any medical conditions that could interfere with the study.
Participants must not be male, as the study is only for females.
Participants must not be under the age of 16 weeks of pregnancy or over 38 weeks and 6 days of pregnancy.
Participants must not be part of a vulnerable population that requires special protection.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Clkn Db Nmxog	Vandoeuvre Les Nancy	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.05.2024

Trial locations

Investigated drugs:

Sulfur Hexafluoride

Contrast-Enhanced Ultrasound (CES) is a special type of ultrasound that uses contrast agents to improve the visibility of blood flow in the placenta and fetus. In this trial, it is used to study the blood circulation in the placenta of pregnant women. The goal is to compare the results between two groups: those with fetal growth restriction and those without. This helps doctors understand how blood flow differences might affect fetal growth.

Investigated diseases:

Foetal growth restriction

Fetal Growth Restriction – Fetal growth restriction is a condition where a fetus does not grow at the expected rate during pregnancy. It is often identified when the fetus’s weight is below the 10th percentile for its gestational age. This condition can result from various factors, including problems with the placenta, maternal health issues, or genetic factors. As the pregnancy progresses, the restricted growth can lead to complications such as reduced oxygen and nutrient supply to the fetus. Monitoring and assessment are crucial to understanding the progression and impact on the fetus.

Trial ID:

2023-506936-34-00

Protocol code:

2021PI062

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Placental Blood Flow in Fetal Growth Restriction Using Sulfur Hexafluoride for Patients Undergoing Medical Termination of Pregnancy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?