RecruitingNAINTERVENTIONAL

Exploration of Allograft Humoral Rejection in Chronic Histiocytic Intervillositis

This research is investigating a rare pregnancy problem called Chronic Histiocytic Intervillositis (CHI). It's quite uncommon, happening in about 5 out of every 10,000 pregnancies, but it can lead to serious complications. These include babies not growing properly (intrauterine growth restriction), babies dying before birth (fetal death in utero), and miscarriages. Currently, we don't fully understand why CHI happens, and the treatments available aren't always effective. Recent discoveries suggest that the mother's immune system might be reacting to the baby's cells in a way similar to how the body rejects a transplant. This study aims to explore this idea further to gain a deeper understanding of CHI, which could eventually help predict risks and find better ways to prevent these difficult pregnancy outcomes.

At a glance

Status

Recruiting

Phase

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

200

Start

11 Oct 2023

Estimated completion

11 Oct 2025

Chronic Histiocytic Intervillositis Intrauterine Growth Retardation Fetal Death in Utero Miscarriage

What is this study about?

This study is looking into a rare pregnancy condition called Chronic Histiocytic Intervillositis, or CHI for short. It's not very common, affecting about 5 out of every 10,000 pregnancies. When a mother has CHI, it can lead to very serious problems during pregnancy. These can include the baby not growing as much as expected, a baby dying before birth (which is called fetal death in utero), or repeated miscarriages.

At the moment, doctors don't fully understand why CHI happens, and the treatments available to prevent these complications aren't always very successful. This means it can be a very worrying and difficult experience for families. However, recent research has given us a new idea about what might be going on. It suggests that the mother's immune system, which normally protects her body from illness, might be reacting to the baby's cells. This reaction is similar to how the body might try to reject an organ transplant, even though the baby is part of the mother's body.

Our study wants to explore this idea further. We hope to learn more about exactly how the mother's immune system might be involved in CHI. By understanding what causes CHI, we aim to find new ways to help doctors predict which pregnancies might be at risk and, ultimately, develop better and more effective treatments to prevent these heartbreaking pregnancy complications.

Key takeaways

Study explores a rare pregnancy condition (CHI) linked to serious complications.
Aims to understand why CHI happens, possibly due to the mother's immune system reacting to the baby.
Hopes to improve ways to predict risks and find better treatments for future pregnancies.
Participation involves providing biological samples (like blood) and possibly existing records.
Your involvement could help many other families experiencing CHI.

Who may be eligible?

To be part of this study, both the mother and father need to be aged 18 or over. If you're a mother who has experienced CHI, we're looking for individuals who have had either a healthy pregnancy followed by at least one complication like poor baby growth, stillbirth, or miscarriage, OR you've had a diagnosis of CHI confirmed by a test on your placenta.

We are also looking for mothers who have experienced miscarriages and have a diagnosed condition called antiphospholipid syndrome. Additionally, some mothers who have had three or more healthy, full-term pregnancies with normal-sized babies are needed for comparison. Fathers need to be the parent of the child from the last pregnancy and any children participating in the study.

There are also some reasons why someone might not be able to join the study. This includes mothers who have had a blood transfusion or an organ transplant. Also, anyone who is under legal protection (like a guardianship) cannot take part. For mothers in the healthy pregnancy group, if there's any suspicion of an infection in the womb, you wouldn't be able to join.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
If you're a mother, have you experienced complications like poor baby growth, stillbirth, or miscarriage, or been diagnosed with CHI?
If you're a mother who has had miscarriages, have you been diagnosed with antiphospholipid syndrome?
Have you NOT had a blood transfusion or organ transplant?
Are you able to agree to take part in the study without pressure or legal restrictions?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, we would collect some biological samples from you. This simply means we would take some blood samples. We might also use existing samples, such as your placenta or DNA from a previous pregnancy, if you've had one where CHI was diagnosed. For those in the antiphospholipid syndrome group, we might use existing samples from a previous miscarriage. The main goal is to gather these samples to help us understand the condition better. There are no medications or treatments involved as part of this specific study, and the total duration would involve the sample collection process and any necessary follow-up for that. We don't specify the number of visits, but it would typically involve one or two appointments for sample collection.

Potential risks and benefits

Participating in this study might not directly benefit you, but your contribution could greatly help us understand CHI better. This understanding could lead to improved predictions and treatments for other families in the future. The risks involved are generally very low, mainly associated with the discomfort of blood draws. Please remember that taking part is completely voluntary, and you are free to change your mind and withdraw from the study at any time without giving a reason, and it will not affect your medical care.

Locations (1)

Antoine Béclère Hospital
Verified postcode
Clamart, France· Recruiting

Common questions

What is Chronic Histiocytic Intervillositis (CHI)?

It's a rare pregnancy condition where a particular type of immune cell builds up in the placenta, which can cause problems for the baby's growth and survival.

What does 'intrauterine growth retardation (IUGR)' mean?

This means your baby is not growing as much as expected while in the womb, often because they're not getting enough nutrients.

What does 'fetal death in utero' mean?

This is a medical term for when a baby dies in the womb before birth.

What are 'biological collections'?

This usually means taking samples like blood to help researchers study the condition.

Will taking part in this study give me a new treatment?

No, this study is focused on understanding the condition better by collecting samples. It's not a study that tests new treatments.

How to find out more

Alexandra LETOURNEAU, Doctor

letourneau.alexandra@aphp.fr 331 45 37 44 76 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.