Induction of Labour for Gestational Diabetes

(EAGER Pilot Trial)

Overseen By Serine Ramlawi, MSc

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: Ottawa Hospital Research Institute

Must not be taking: Low molecular weight heparin

Disqualifiers: Pre-pregnancy diabetes, Hypertension, Preeclampsia, Prior Cesarean, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 1 week

260 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether inducing labor at 38 weeks can reduce serious health risks for mothers and babies with gestational diabetes, a type of diabetes that begins during pregnancy. Participants will either have labor induced between 38 weeks and 38 weeks plus 6 days or wait for labor to start naturally, unless a medical reason requires earlier delivery. This study suits those with gestational diabetes diagnosed after 24 weeks who are expecting one baby, have no prior C-sections, and plan to give birth at a participating center. As an unphased trial, it offers participants the chance to contribute to important research that may improve outcomes for mothers and babies with gestational diabetes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that induction of labour is safe for gestational diabetes?

Research has shown that starting labor for individuals with gestational diabetes around 38 to 39 weeks is generally safe. Some studies suggest that this timing might reduce the likelihood of needing a C-section and lower the risk of high blood pressure issues, such as pre-eclampsia. Inducing labor could benefit both mothers and babies, with no major safety concerns reported. However, not all experts agree on these benefits, and some research finds no clear advantage if there are no other complications. Overall, inducing labor at this stage for gestational diabetes appears safe for many. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the induction of labor for gestational diabetes because it offers a proactive approach compared to the standard expectant management. Typically, gestational diabetes is monitored closely, with interventions like dietary control, insulin therapy, and waiting for natural labor to begin. However, inducing labor between 38 weeks and 38 weeks + 6 days could potentially reduce complications for both the mother and baby by preventing prolonged pregnancies. This approach aims to manage risks associated with gestational diabetes more effectively, possibly leading to better outcomes for mothers and their newborns.

What evidence suggests that induction of labour might be an effective treatment for gestational diabetes?

This trial will compare two approaches for managing gestational diabetes: expectant management and induction of labor. Research has shown that inducing labor at 38 or 39 weeks for women with gestational diabetes can be beneficial. Studies have found that it may lower the likelihood of needing a C-section and reduce the risk of high blood pressure. It can also decrease the chance of delivering a larger-than-average baby, which is common with gestational diabetes, and help prevent severe tears during delivery. However, some research suggests that if no other complications exist, early labor induction might not be necessary. Overall, evidence supports early labor in certain cases, particularly to avoid specific risks associated with waiting for labor to begin naturally. ^{1 2 3 4 6}

Who Is on the Research Team?

Mark C Walker, MD, MSc, MHM

Principal Investigator

Ottawa Hospital Research Institute

Darine El-Chaâr, MD, FRCS(C), MSc

Principal Investigator

Ottawa Hospital Research Institute

Are You a Good Fit for This Trial?

This trial is for individuals with gestational diabetes diagnosed after 24 weeks of pregnancy, carrying a single baby in head-down position, planning to deliver at a participating site. They must be between 37 and 38 weeks +2 days pregnant based on ultrasound or IVF dates and be aged 16 or older.

Inclusion Criteria

I am pregnant with one baby.

My pregnancy has a confirmed live fetus.

My baby is positioned head-down for birth.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Enrollment and Randomization

Participants are enrolled and randomized into either the induction of labour or expectant management arms

1 day

1 visit (in-person)

Treatment

Participants undergo either induction of labour between 38 weeks + 0 days and 38 weeks + 6 days or expectant management until spontaneous labour

1 week

1 visit (in-person)

Postpartum Assessment

Participants are assessed after delivery and up to 72 hours postpartum for study feasibility and clinical data collection

3 days

1 visit (in-person)

Follow-up

Participants are monitored for secondary health resource use and participant satisfaction at 6 weeks postpartum

6 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Induction of Labour

Trial Overview The EAGER pilot trial is testing if inducing labor at 38 weeks (IOL) is better than waiting for natural labor (EM) in reducing severe newborn health issues among those with gestational diabetes. Participants are randomly assigned to either induced labor or expectant management.

How Is the Trial Designed?

Group I: Induction of Labour between 38 weeks + 0 days and 38 weeks + 6 days Experimental Treatment 1 Intervention

Induction of Labour between 38+0 weeks and 38+6 weeks.

Group II: Expectant Management Active Control 1 Intervention

Expectant management without intervention until spontaneous labour, or earlier at the discretion of the attending healthcare provider.

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials

585

Recruited

3,283,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10075038/

Gestational diabetes mellitus: The optimal time of delivery Melamed et al[30] also found that the induction of labor at (39-39) + 6 wk of gestation significantly reduced the rate of cesarean section in patients with GDM; ...

2. evidencebasedbirth.com evidencebasedbirth.com/evidence-on-induction-for-gestational-diabetes/

Evidence on: Induction for Gestational Diabetes They found that inducing labor at 38 or 39 weeks for GDM is linked to a lower rate of Cesareans, less pre-eclampsia/hypertension, and more ...

3. bmcpregnancychildbirth.biomedcentral.com bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-023-05779-z

Comparison of adverse maternal and perinatal outcomes ... For GDM women, induction may reduce the risk of macrosomia and severe perineal lacerations compared to expectant management.

4. ajog.org ajog.org/article/S0002-9378(15)02542-9/fulltext

Induction of labor before 40 weeks is associated with lower ... In women with gestational diabetes mellitus, the routine induction of labor at 38 or 39 weeks is associated with a lower risk of cesarean delivery compared ...

5. sarawickham.com sarawickham.com/articles-2/induction-for-gestational-diabetes/

Induction for gestational diabetes: what's the evidence? The summary: There is no evidence to support induction of labour in women with gestational diabetes and no other complications. The problems ...

6. gynaecology-obstetrics-journal.com gynaecology-obstetrics-journal.com/induction-of-labour-in-pregnancies-with-gestational-diabetes-mellitus-maternal-and-neonatal-outcomes-a-single-centre-experience/

Induction of labour in pregnancies with gestational ... Objective. To assess maternal and foetal outcomes in pregnancies with gestational diabetes mellitus undergoing induction of labour. Materials and Methods.