RecruitingNAINTERVENTIONAL

The Feasibility Of Expectant Management Versus Induction At 38 Weeks Among Individuals With Gestational Diabetes Mellitus: A Randomized Controlled Pilot Trial (EAGER Pilot Trial)

This study, called the EAGER Pilot Trial, wants to find the best time for pregnant people with gestational diabetes to give birth. It's comparing two approaches: inducing labour at 38 weeks of pregnancy versus waiting for labour to start on its own. The main goal is to see if inducing labour reduces serious problems for the baby and the birthing parent. This is a small, initial study to make sure a bigger study would work well. It will help researchers understand how to properly set up a future main trial, including finding enough participants and collecting information effectively. Participants will be followed up after birth and again about six weeks later.

At a glance

Status

Recruiting

Phase

Sponsor

Ottawa Hospital Research Institute

Enrolment target

260

Start

07 Apr 2025

Estimated completion

01 Mar 2028

Gestational Diabetes Mellitus (GDM)

What is this study about?

This study is called the EAGER Pilot Trial, and it's looking into an important question for pregnant people with a condition called gestational diabetes. Gestational diabetes is a type of diabetes that develops during pregnancy and usually goes away after the baby is born. While it can often be managed, it can sometimes increase the risk of certain problems for both the birthing parent and the baby.

The main question this study wants to answer is whether it's better to induce labour (start it artificially) at 38 weeks of pregnancy, or to wait for labour to start naturally. Doctors want to find out which approach leads to fewer serious health problems for parents and babies. Because this is a pilot study, it's a smaller test run to see if a much larger study on this topic would be possible and how best to carry it out in the future.

Researchers will invite around 260 pregnant people in Canada to take part. They will be split into two groups by chance: one group will have their labour induced at 38 weeks, and the other will wait to see if labour starts naturally. The study will collect information about their health, their baby's health, and their experiences to help plan a bigger, more definite study later on.

Key takeaways

This study compares inducing labour at 38 weeks with waiting for natural labour for people with gestational diabetes.
It's a small 'pilot' study to help plan a bigger trial in the future.
The goal is to find the safest timing for birth for both parent and baby.
Participants will be split into two groups by chance.
Participation involves a few visits: joining, after delivery, and 6 weeks postpartum.
You can withdraw from the study at any time.

Who may be eligible?

You might be able to join this study if you are pregnant, at least 16 years old, and have been diagnosed with gestational diabetes after 24 weeks of pregnancy. You must be carrying one baby, and your baby needs to be head-down and in good health before you join the study. Your pregnancy dating must also be clear, typically based on an early ultrasound scan.

However, there are reasons why you might not be able to take part. For example, if you had diabetes before getting pregnant, or if you or your baby have certain health issues that mean you need special medical care already. This includes things like having a health problem that requires immediate delivery, signs of labour starting early, or if there's a reason you can't have a vaginal delivery.

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 16 years old or older?
Have you been diagnosed with gestational diabetes during this pregnancy?
Are you pregnant with only one baby, and is the baby in a head-down position?
Are you between 36 and 38 weeks pregnant when considering joining?
Do you have any other serious health conditions that require urgent delivery now?
Are you able to deliver at one of the hospitals taking part in the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, your journey will involve a few steps. First, you'll have an initial visit where you'll learn more about the study and decide if you want to join. If you do, you'll be randomly assigned to one of two groups: either to have your labour induced between 38 weeks and 38 weeks and six days of pregnancy, or to wait for labour to begin naturally (unless there's a medical reason for earlier delivery).

During this first visit, researchers will collect some basic health information from you and your medical records. When you go into hospital to have your baby, you might be asked to provide a blood sample. After your baby is born, and within 72 hours, there will be another check-up to gather information about your delivery and your health. Finally, about six weeks after your baby is born, you'll be asked to complete a survey about any healthcare services you've used since the birth. The total duration of your active participation will be up to about 6 weeks after your baby is born.

Potential risks and benefits

Taking part in any research study has potential benefits and risks. A potential benefit of this study is helping researchers understand the best timing for delivery for people with gestational diabetes, which could improve care for future pregnancies. There are no direct personal benefits guaranteed for participants. As with any medical procedure, induction of labour has its own set of potential risks and discomforts, just as waiting for labour might have different risks. Your doctor will discuss these with you. Remember, deciding whether to join is entirely up to you and you can withdraw from the study at any time without it affecting your medical care.

Locations (1)

The Ottawa Hospital
Verified postcode
Ottawa, Canada· Recruiting

Common questions

What is gestational diabetes?

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

What does 'inducing labour' mean?

'Inducing labour' means starting the birth process artificially with medicines or other medical methods, rather than waiting for it to begin naturally.

Why is this only a 'pilot' study?

A pilot study is a small, preliminary study. It helps researchers test their plans and make sure a larger, more comprehensive study in the future will be successful and well-organised.

Will I get to choose which group I'm in?

No, you will be assigned to a group randomly, like flipping a coin. This helps make the study fair and scientific.

If I join, does it affect my regular pregnancy care?

No, your regular medical care for your pregnancy will continue as normal. This study is designed to fit around your existing care.

How to find out more

Malia Murphy, PhD

malmurphy@ohri.ca 613-737-8899 Official trial record

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