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.
Em resumo
Sobre o que é este estudo?
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.
Pontos principais
- 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.
- Você pode se retirar do estudo a qualquer momento.
Quem pode ser elegível?
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.
Este estudo pode ser adequado para você?
Responda a estas perguntas rápidas para ver se você pode ser elegível. Este é apenas um guia — a decisão final é da equipe de pesquisa.
- Você tem 16 anos ou mais?
- 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?
O que envolve a participação?
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.
Riscos e benefícios potenciais
Localizações (1)
- O Hospital de OttawaCódigo postal verificadoOttawa, Canadá· Recrutamento
Perguntas frequentes
O que é diabetes gestacional?
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.
Como saber mais
Malia Murphy, PhD
Sempre consulte seu médico ou especialista antes de decidir participar de um estudo.
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Desenvolvido pelo nosso fórum em community.patient.info. Por favor, seja respeitoso — isto não é um conselho médico.