RecruitingNAINTERVENTIONAL

New Markers of Glycation to Predict Gestational Diabetes Mellitus and Macrosomia.

This study is investigating new ways to spot gestational diabetes and the chance of a baby being born much larger than expected. Gestational diabetes can increase a baby's size and lead to other problems. Currently, screening methods are debated, and sometimes problems like a baby growing too large can start before these checks are even done. This research aims to compare new tests, called skin autofluorescence and glycated albumin, with a more common test (HbA1c). The goal is to see if these new tests are better at predicting gestational diabetes, larger babies, and other related issues in pregnant women. Learning this could help doctors offer better care and support earlier in pregnancy.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Bordeaux

Enrolment target

800

Start

18 Dec 2023

Estimated completion

01 Sep 2028

Macrosomia, Fetal Gestational Diabetes Mellitus in Pregnancy

What is this study about?

This research is looking into how we can better predict two important things during pregnancy: gestational diabetes and the likelihood of a baby being born larger than average. Gestational diabetes is a type of diabetes that develops during pregnancy, and it can sometimes lead to babies being born larger than doctors would ideally like. When a baby is born much larger than expected, it's called macrosomia, and it can sometimes lead to complications for both the mother and baby during birth and afterwards.

Currently, there are ways to check for gestational diabetes, but doctors are always looking for improvements. Sometimes, a baby might start growing larger before current screening methods are even used. This study is exploring if some newer tests, which look at markers related to sugar levels in the body over time, could give us an earlier warning. These new tests are called 'skin autofluorescence' and 'glycated albumin'. The researchers will compare these new tests against a widely used test called 'HbA1c' to see which ones are best at predicting the risks.

Ultimately, the results of this study could help doctors develop better ways to identify pregnant women who might be at higher risk for gestational diabetes and having a larger baby. Knowing this earlier could allow mothers and their healthcare teams to take steps to manage these conditions sooner, potentially leading to healthier outcomes for both mother and child.

Key takeaways

The study explores new ways to predict gestational diabetes and larger babies.
It compares new tests (skin and blood) with current methods.
Participation involves blood tests and a simple skin check, no new medicines.
Results could help doctors offer earlier, better care for pregnant women.
You can stop participating at any time without affecting your usual care.

Who may be eligible?

To join this study, you need to be at least 18 years old and be pregnant with one baby. If you initially had twins and one was naturally or medically reduced before 14 weeks of pregnancy, you might still be able to join. You must also be less than 28 weeks pregnant when you sign up for the study, and you need to be covered by a social security scheme.

There are also some reasons why you might not be able to join. For example, if you are 28 weeks pregnant or more, or if you are pregnant with more than one baby. If you knew you had diabetes before getting pregnant, or if you've had weight loss surgery (bariatric surgery), you wouldn't be able to take part. Also, if you expect to give birth at a hospital that isn't involved in this study, or if you are in prison, or have a legal guardian or conservator, you wouldn't be eligible.

It's important to remember that the study team will go through all these details with you to make sure it's the right fit. Giving your permission to take part, known as 'consent', is also a key part of the process.

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?
Are you pregnant with one baby (or had one twin reduce early in pregnancy)?
Are you less than 28 weeks pregnant right now?
Do you have social security coverage (like NHS in the UK)?
Do you not have diabetes already (before pregnancy)?
Have you not had bariatric (weight loss) surgery?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you won't need to take any new medicines. Your involvement will mainly include providing some blood samples and having a simple, non-invasive skin test (skin autofluorescence). These tests would be done at various points during your pregnancy, alongside your usual antenatal care. The study aims to follow you throughout your pregnancy to see how these markers change and what they might predict for your baby's birth. The total duration of your participation would cover your pregnancy until delivery.

Potential risks and benefits

Taking part in any study has potential aspects to consider. A potential benefit of this study is that it might help improve how we predict gestational diabetes and baby size in the future, which could lead to better care for pregnant women. The risks are generally low, mainly involving the minor discomfort and very small chance of bruising from blood tests. You are always in control and free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Hopital Pellegrin
Verified postcode
Bordeaux, France· Recruiting

Common questions

What is gestational diabetes?

Gestational diabetes is a type of diabetes that develops for the first time during pregnancy. It usually goes away after the baby is born.

What does 'macrosomia' mean?

Macrosomia means that a baby is born much larger than average for their gestational age. This can sometimes lead to difficulties during birth.

Will I have to take new medicine in this study?

No, this study does not involve taking any new medications. It's about testing and observing.

How often will I need to visit the clinic?

Visits will be similar to your standard antenatal check-ups, with additional blood tests and a skin test at certain points during your pregnancy.

Can I stop participating if I change my mind?

Yes, you can choose to stop participating in the study at any time, for any reason, without it affecting your medical care.

How to find out more

FOUSSARD NINON, Dr

ninon.foussard@u-bordeaux.fr 5.57.65.60.78 Official trial record

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