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

Trial Summary

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 data supports the effectiveness of the treatment Induction of Labour for Gestational Diabetes?

Research suggests that inducing labor in women with gestational diabetes at term can reduce the need for cesarean sections and improve outcomes for both mothers and babies compared to waiting for labor to start naturally. ^{1 2 3 4 5}

Is induction of labor safe for women with gestational diabetes?

Research shows that induction of labor for women with gestational diabetes is generally safe, but it may be associated with some risks, such as adverse outcomes for the baby. However, it can also lead to a lower rate of cesarean deliveries, which is a major surgery with its own risks. ^{1 2 3 6 7}

How does the treatment 'Induction of Labour' differ from other treatments for gestational diabetes?

Induction of Labour for gestational diabetes is unique because it involves starting labor artificially to avoid complications like excessive fetal growth and potential Cesarean delivery, rather than waiting for labor to begin naturally. This approach is different from other treatments that focus on managing blood sugar levels through diet, exercise, or medication. ^{1 4 7 8 9}

What is the purpose of this trial?

The EAGER pilot trial is designed to assess the feasibility of a Canadian, multicentre prospective randomized open-label blinded end-point (PROBE) clinical trial addressing whether induction of labour (IOL) at 38 weeks' gestation compared to expectant management (EM) reduces severe perinatal mortality and morbidity among individuals with gestational diabetes mellitus (GDM). Eligible participants will be recruited between 36 weeks + 0 days and 38 weeks + 0 days gestation. Participants will be randomized to one of two arms: * Intervention Arm: IOL between 38 weeks + 0 days and 38 weeks + 6 days OR * Control Arm: EM without intervention until spontaneous labour, or earlier if a medical indication arises. A total of 260 participants (130 per group) will be recruited from Canadian sites, where participants will have 3 study visits: 1. Enrollment and randomization 2. After delivery and up to 72 hours postpartum 3. 6 weeks postpartum At enrollment and randomization, patient-reported baseline and clinical data from medical charts will be collected. Upon admission to hospital for labour and delivery, a blood sample will be collected to assess HbA1C and plasma glucose levels. After delivery and up to 72 hours postpartum, study feasibility will be assessed through patient-reported outcomes and administrative and clinical data. At 6 weeks postpartum, participants will be surveyed for secondary health resource use. Findings from this pilot will inform the design, implementation and feasibility of a future full-scale randomized controlled trial.

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

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

Immediate delivery or expectant management in gestational diabetes at term: the GINEXMAL randomised controlled trial. [2022]

2. Australia pubmed.ncbi.nlm.nih.gov

Maternal and neonatal outcomes of women with gestational diabetes and without specific medical conditions: an Australian population-based study comparing induction of labor with expectant management. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Induction of labor versus expectant management for gestational diabetes mellitus at term. [2020]

4. Germany pubmed.ncbi.nlm.nih.gov

Perinatal outcome following induction of labor in patients with good glycemic controlled gestational diabetes: does timing matter? [2020]

5. Austria pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of induction at 38 weeks versus 40 weeks gestation on maternal and infant outcomes in women with insulin-controlled gestational diabetes. [2022]

6. Uganda pubmed.ncbi.nlm.nih.gov

Factors associated with adverse obstetric events following induction of labour: a retrospective study in a tertiary hospital in Ghana. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Induction of labor before 40 weeks is associated with lower rate of cesarean delivery in women with gestational diabetes mellitus. [2019]

8. Poland pubmed.ncbi.nlm.nih.gov

Influence of gestational diabetes mellitus on outcomes of preinduced labour with dinoprostone vaginal insert. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Induction of labor versus conservative management of pregnant diabetic women. [2006]