RecruitingNAINTERVENTIONAL

Determinants of Repeated Spontaneous Miscarriages and Unexplained Fetal Deaths

This study, called DEFI-2, is investigating why some women experience repeated miscarriages (three or more in the first three months of pregnancy) or unexplained stillbirths (after the third month). For about half of these couples, doctors can't find a clear reason. The researchers want to identify specific factors, especially genetic ones, that might be involved. They're looking for volunteers who have experienced these issues to provide biological samples (like blood) from both partners. This will help them gather more information to understand the causes and potentially find ways to help couples in the future. The project builds on an earlier study (DEFI-1) and aims to confirm and expand on those findings.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Brest

Enrolment target

200

Start

05 Oct 2020

Estimated completion

05 Oct 2057

Repeated Spontaneous Miscarriages Fetal Deaths in Utero

What is this study about?

Imagine wanting to start or grow your family, but facing the heartbreak of a miscarriage again and again, or the tragedy of a baby stillborn without a clear reason. This can be a very difficult, confusing, and upsetting experience for many couples. For about half of these couples, doctors can't pinpoint the exact cause, which can make it even harder to cope and plan for the future. This study, called DEFI-2, aims to change that.

The researchers are trying to understand why some women experience repeated miscarriages (meaning three or more happen in the first three months of pregnancy) or why some babies are stillborn without an obvious explanation in the later stages of pregnancy. They believe there might be hidden reasons, especially genetic factors or problems with how blood clots, that could be playing a role. By gathering more information from many couples who have been through this, they hope to uncover these underlying causes.

Ultimately, the goal of this research is to gain a deeper understanding of these painful situations. This understanding could lead to better ways to support couples in the future, offer more specific advice, and potentially even develop new treatments or preventive measures. It's about shedding light on a very difficult area of health to improve outcomes for families.

Key takeaways

The study investigates causes of repeated miscarriages and unexplained stillbirths.
It aims to identify hidden factors, especially genetic ones, by studying biological samples.
Participation involves providing a blood sample from both partners.
The research helps researchers understand these difficult situations for future support.
There are no direct medical benefits to participants, but contributions help others.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To take part in this study, you and your partner would need to meet certain conditions.

Your wife must be between 18 and 40 years old (inclusive), and you, her husband, must be over 18. Together, you must have experienced at least three unexplained miscarriages in the first three months of pregnancy, OR one unexplained stillbirth in the second or third three months of pregnancy. Important: the doctors must have already ruled out common clear causes for these events, such as known issues with the baby's umbilical cord, a clear problem with the baby itself, or a severe condition called pre-eclampsia.

Both you and your partner must be willing to give your informed consent to participate, meaning you understand what the study involves and agree to be part of it. You also need to be covered by a social security scheme. You cannot take part if either of you are under legal protection or if the wife is currently taking blood-thinning medication. If doctors have already found a clear reason for your miscarriages or stillbirths, you would not be eligible for this specific study.

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 a couple where the wife is between 18 and 40 years old?
Is the husband over 18 years old?
Has the wife experienced three or more miscarriages in the first three months of pregnancy without a known cause?
OR, has the wife experienced one stillbirth in the second or third trimester without a known cause?
Have doctors already ruled out common identifiable reasons for these events?
Are neither of you on legal protection or is the wife taking blood-thinning medication?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it would involve both you and your partner providing a biological sample, most likely a blood test. There would be no medication to take as part of the study itself, nor would there be specific follow-up appointments solely for the research. The study aims to collect information and samples to understand the causes of repeated miscarriages and stillbirths. The exact number of visits or the duration for you would be minimal, mainly focused on providing the sample and giving your consent.

Potential risks and benefits

The main benefit of taking part in this study is contributing to a better understanding of repeated miscarriages and unexplained stillbirths, which could help future couples. There are no direct medical benefits to you personally from participating. The risks are very low, primarily those associated with a blood draw, such as a small bruise or slight discomfort. You, or your partner, have the right to withdraw from the study at any time without giving a reason, and this would not affect your current or future medical care.

Locations (1)

BREST
Verified postcode
Brest, France· Recruiting

Common questions

What is the purpose of this study?

This study aims to find out why some couples experience repeated miscarriages or unexplained stillbirths, particularly looking for genetic or blood-related causes.

Who can take part in this study?

Couples where the woman is 18-40, the man is over 18, and they have had at least 3 unexplained miscarriages or 1 unexplained stillbirth. Clear causes must already be ruled out.

What will I have to do if I join?

You and your partner will need to provide a biological sample, typically a blood sample. You will also need to give your informed consent.

Are there any risks to participating?

Risks are very low, mainly minor discomfort or bruising from a blood test. There are no direct medical treatments or interventions in this study.

Can I stop participating if I change my mind?

Yes, you are free to withdraw from the study at any time without giving a reason, and your medical care will not be affected.

How to find out more

Elisabeth Pasquier, MD

elisabeth.pasquier@chu-brest.fr 0298145013 Official trial record

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