RecruitingOBSERVATIONAL

Early Versus Late Monitoring Among Pregnant Women With a History of Gestational Diabetes

This study aims to understand the best way to care for pregnant women who have had gestational diabetes in a previous pregnancy. We are comparing two approaches: one group will check their blood sugar levels regularly from early in their current pregnancy, while another group will have a sugar tolerance test later, around 28 weeks. The study will look at various health outcomes for both the mothers and their babies, such as birth weight, the need for C-sections, and if the baby needs extra care. We hope to find out which approach leads to healthier pregnancies and babies, especially since gestational diabetes can affect future health for both mum and child.

At a glance

Status

Recruiting

Sponsor

Imperial College London

Enrolment target

200

Start

20 Nov 2023

Estimated completion

31 Dec 2026

Pregnancy Complications Gestational Diabetes

What is this study about?

This study is particularly for pregnant women who have had gestational diabetes in a past pregnancy. We know that if you've had gestational diabetes once, you have a higher chance of getting it again in a future pregnancy. This condition, which means high blood sugar during pregnancy, can also increase the risk of health problems for both the mother and the baby, sometimes even many years later. Doctors are trying to find the best way to look after mums like you to make sure both you and your baby stay as healthy as possible during pregnancy.

Currently, there are different ways doctors manage pregnant women who have a history of gestational diabetes. Some doctors suggest checking blood sugar levels very early in the pregnancy, usually by testing your own blood sugar regularly at home. Others recommend waiting until about 28 weeks into the pregnancy for a special sugar tolerance test. This study wants to compare these two options to see which one works better for mums and babies. We will be looking at important things like how the birth goes, the baby's health at birth, and whether mums need extra help to control their blood sugar.

Besides looking at general health outcomes, the study also has a deeper part. Researchers will investigate how these different ways of monitoring might affect very tiny things in your body and your baby's, like special chemicals in your urine and blood, and even tiny bugs in your gut. They will also look at how the placenta, which feeds your baby, and the umbilical cord are affected. This detailed research helps us understand exactly why one approach might be better than the other, giving us important clues for future treatments.

Key takeaways

This study compares two ways to manage pregnancy for women with a history of gestational diabetes.
It checks if early blood sugar monitoring improves health outcomes for mum and baby.
It investigates both general health results and tiny changes in your body.
Participation involves either early blood sugar checks or a later sugar tolerance test.
The findings aim to help improve future care for women with this history.

Who may be eligible?

To join this study, you need to be pregnant and over 16 years old. A key requirement is that you must have been diagnosed with gestational diabetes in a previous pregnancy using a sugar tolerance test. Also, you must be carrying one baby in your current pregnancy.

There are also some reasons why you wouldn't be able to join. For example, if you are carrying more than one baby, or if you've had weight-loss surgery (bariatric surgery). You also can't be in the study if you are already taking certain medications for blood sugar like metformin, or if a recent blood test (called HbA1c) shows your long-term blood sugar levels are already quite high.

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?
Are you over 16 years old?
Did you have gestational diabetes in a past pregnancy, diagnosed by a sugar tolerance test?
Are you currently pregnant with only one baby?
Have you NOT had weight-loss surgery?
Are you NOT currently taking metformin or similar blood sugar medication?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be placed into one of two groups. One group will regularly check their blood sugar levels early in the pregnancy. The other group will have a sugar tolerance test later in the pregnancy, around 28 weeks. For a smaller number of participants (about 25 people in total), there would be additional collections of urine and blood samples, both at the start of the study and again at 28 weeks. For these same smaller groups, if you consent, samples from the umbilical cord, placenta, and cord tissue would also be collected after your baby is born. For all women in the study, information about your delivery and your baby's health outcomes will be collected. The total duration of your participation would last until after your baby is born and initial health data is gathered.

Potential risks and benefits

Participating in this study might offer the benefit of receiving close monitoring during your pregnancy, potentially leading to better understanding of your specific needs. There are no direct medical risks from the study's monitoring approaches, as they are standard practices. However, as with any medical study, there's always the chance that the information collected won't directly benefit you personally, but it will help other pregnant women in the future. You are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Chelsea and Westminster Trust
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is gestational diabetes?

It's a type of diabetes that develops during pregnancy and usually goes away after the baby is born. If you've had it before, you're at a higher risk of getting it again.

What does 'early monitoring' mean?

It means you'll be checking your blood sugar levels regularly, usually at home, from fairly early in your pregnancy.

What is a 'sugar tolerance test'?

This is a test where you drink a sugary drink, and your blood sugar is checked before and after to see how your body handles sugar.

Will I know which group I'm in?

Yes, you will be aware of whether you are in the 'early monitoring' group or the 'late monitoring' group.

Do I have to give extra samples like blood and urine?

Only a small number of participants will be asked to give extra samples, and you would be asked for your separate consent for this specific part of the study.

How to find out more

Natasha Singh, MBBS FRCOG

n.mohammed@imperial.ac.uk 02033159892 Official trial record

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