RecruitingOBSERVATIONAL

Selective Fetal Growth Restriction in Monochorionic Twins - an International Investigation

This international study aims to better understand why one baby might grow slower than the other in identical twin (monochorionic) pregnancies, a condition known as selective fetal growth restriction (sFGR). Currently, it's hard to predict which pregnancies will have problems, which causes a lot of worry for parents. There's also not much known about how sFGR affects the babies' brain development or the emotional well-being of the parents. By looking at ultrasound scans, placentas, and following children for two years, researchers hope to improve diagnosis, better predict outcomes, and provide more support to families. This will help doctors give more accurate advice and reduce stress for expectant parents.

At a glance

Status

Recruiting

Sponsor

Leiden University Medical Center

Enrolment target

274

Start

17 Feb 2023

Estimated completion

01 Mar 2028

Twin; Pregnancy, Affecting Fetus or Newborn Fetal Growth Retardation Twin Monochorionic Diamniotic Placenta Twin Diseases

What is this study about?

This important international study is looking into a condition called selective fetal growth restriction (sFGR) in identical twin pregnancies. In these pregnancies, the twins share one placenta, but sometimes one baby doesn't grow as well as the other. This can be very worrying for expectant parents, as it can lead to complications during the pregnancy or birth.

Currently, it's quite difficult for doctors to predict how these pregnancies will progress and which babies might be at higher risk. This uncertainty can make it hard for doctors to give clear advice, and it often leaves parents feeling very anxious. This study aims to improve how doctors diagnose sFGR and how accurately they can predict what will happen next. It also wants to understand more about why sFGR happens in the first place by looking closely at the placenta.

The researchers will also be exploring something that hasn't been looked into much before: how sFGR might affect the twins' brain development as they grow, and the emotional impact on parents during and after the pregnancy. By gathering all this information, the study hopes to find better ways to support families going through a selective fetal growth restriction pregnancy, giving them clearer information and reducing their worries.

Key takeaways

This study focuses on identical twin pregnancies where one baby isn't growing as well.
It aims to improve diagnosis and prediction of selective fetal growth restriction (sFGR).
Researchers want to understand how sFGR affects babies' development and parents' feelings.
Taking part involves extra ultrasound scans and follow-up until your children are two.
The goal is to provide better information and support to families in the future.

Who may be eligible?

To join this study, you would need to be pregnant with identical twins (meaning they share one placenta) and have been diagnosed with selective fetal growth restriction (sFGR) before 28 weeks of pregnancy. You and your partner (if you have one and they share parental responsibility) must both be at least 18 years old and able to agree to take part.

It's important that both parents (if applicable) are willing to give written permission to be part of the study, including follow-up for the children until they are two years old.

You wouldn't be able to join the study if either twin has a life-threatening problem, if you're expecting more than two babies, or if there are other specific twin complications like TTTS (twin-to-twin transfusion syndrome) or TAPS (twin anaemia polycythaemia sequence) at the time sFGR is first diagnosed.

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 pregnant with identical twins?
Has one of your twins been diagnosed with slower growth (sFGR) before 28 weeks of pregnancy?
Are you (and your partner, if applicable) aged 18 years or older?
Are you willing for your children to be followed up until they are two years old?
Are your twins healthy otherwise, with no other major complications like TTTS?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the doctors would use more detailed ultrasound scans than usual to monitor your pregnancy. They will look closely at how the blood flows through the umbilical cord to each baby. After the babies are born, the placenta would be examined very carefully in a lab to understand more about its structure. The study also involves checking the development of your children when they are two years old. Additionally, researchers will ask you about your emotional well-being during the pregnancy and after birth, to understand the impact of having an sFGR pregnancy on parents. The total duration of your participation, including follow-up, would be until your children reach two years of age.

Potential risks and benefits

Taking part in this study may offer some benefits by providing you with more detailed information about your pregnancy and potentially contributing to a better understanding of sFGR for future families. However, you should be aware that being part of a study like this might involve more hospital visits or tests than a standard pregnancy. There are no known direct medical risks from the study procedures themselves, as they involve standard ultrasound and examinations. You have the right to withdraw from the study at any time without giving a reason, and this decision will not affect the care you receive for your pregnancy and babies.

Locations (6)

Boston Children's Hospital
Verified postcode
Boston, United States· Recruiting
Universitaire Ziekenhuizen Leuven
Verified postcode
Leuven, Belgium· Recruiting
Mount Sinai Hospital
Verified postcode
Toronto, Canada· Recruiting
Leiden University Medical Center
Verified postcode
Leiden, Netherlands· Recruiting
BCNatal
Verified postcode
Barcelona, Spain· Recruiting
Karolinska University Hospital
Verified postcode
Stockholm, Sweden· Not yet recruiting

Common questions

What does 'monochorionic twins' mean?

Monochorionic twins are identical twins that share a single placenta in the womb.

What is 'selective fetal growth restriction' (sFGR)?

It's when one of the identical twins isn't growing as well as the other in the womb because they aren't getting enough nutrients from the placenta.

Will taking part in this study change the treatment I receive?

The study aims to gather information, but your medical care will always be decided by your doctors based on what's best for you and your babies.

What kind of ultrasound scans will be performed?

You'll have detailed ultrasound scans, similar to regular pregnancy scans, but with extra focus on blood flow in the umbilical cord and how the babies are growing.

Will my information be kept private?

Yes, all your personal information gathered for the study will be kept confidential and anonymous to protect your privacy.

How to find out more

Anne Noll, MD

a.t.r.noll@lumc.nl +32 16 34 47 50 Official trial record

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