The EAGER Pilot Trial

Gestational diabetes mellitus (GDM) is a common pregnancy complication that can lead to various negative health outcomes for both mother/birthing parent and baby. Recent research suggests that induction of labour (procedures or drugs used to stimulate birth) between 37 and 41 weeks of pregnancy may reduce some of these risks compared to expectant management (waiting until labour begins on its own or prompting labour and/or delivery to occur earlier if medically necessary).

However, there is still limited research, and no agreement amongst medical experts on the benefits of inducing labor after 37 weeks in pregnancies affected by GDM.

WHY IS THIS STUDY BEING DONE?

The purpose of this study, called a pilot study or a feasibility study, is to test if it is reasonable to conduct a larger study to determine if induction of labour between 38 weeks + 0 days and 38 weeks + 6 days gestation reduces the risk of serious health problems or death among pregnant individuals with GDM and their infants, compared to expectant management.

WHO CAN PARTICIPATE?

You might be eligible if:

You have been diagnosed with GDM in your current pregnancy
You are pregnant with one baby
You are planning to deliver at one of the following centres:
- The Ottawa Hospital, Ottawa

WHAT WILL HAPPEN DURING THIS STUDY?

If you decide to participate, you will be put into a group by chance (like flipping a coin) into one of the groups below.

Group 1 – Induction of labour. If you are randomized to this group, you may have an induction of labour between 38 weeks + 0 days and 38 weeks + 6 days. The type of induction and induction procedures will be determined and conducted by your healthcare provider at the hospital where you are planning to deliver. This study will not change the method of induction that you and your healthcare provider determine is best for you.

Group 2 – Expectant management. If you are randomized to this group, you will receive expectant management until spontaneous labour, or earlier if a medical indication arises. If there is a medical reason for you to deliver your baby early, your healthcare provider may recommend that your labour be induced.

Your participation will last from the day you provide consent to participate until 6 weeks after you are discharged from the hospital after your baby is born. Once you have been put in a group, you will be asked to complete three electronic questionnaires and give a blood sample during your pregnancy. Information about your pregnancy, delivery and newborn will be collected from your medical charts.

IF YOU WANT TO PARTICIPATE

You may fill in the “Contact Us” form below and the research team at your planned delivery hospital will contact you.

CONTACT US

Note:

Your contact information will be securely sent to the appropriate participating site based on your location of delivery. The study team from the site will contact you directly.