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| ID | Type | Description | Link |
|---|---|---|---|
| PJT-191790 | Other Grant/Funding Number | Canadian Institutes of Health Research |
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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 consented between 32 weeks + 0 days and 38 weeks + 0 days gestation and randomized between 36 weeks + 0 days and 38 weeks + 0 days gestation. Participants will be randomized to one of two arms:
A total of 260 participants (130 per group) will be recruited from Canadian sites, where participants will have 3 study visits:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Induction of Labour between 38 weeks + 0 days and 38 weeks + 6 days | Experimental | Induction of Labour between 38+0 weeks and 38+6 weeks. |
|
| Expectant Management | No Intervention | Expectant management without intervention until spontaneous labour, or earlier at the discretion of the attending healthcare provider. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Induction of Labour | Procedure | Induction of Labour (IOL) will occur between 38+0 weeks and 38+6 weeks. All participating sites will follow an evidence-based approach for IOL, which may include any of the following: use of prostaglandins, oxytocin, amniotomy, or intracervical balloon catheters with and without extra-amniotic saline infusion for the intervention arm. Participants who are induced in either the intervention or control arms will be managed by their delivery care provider to ensure sufficient time to labour and determine when to proceed to Cesarean delivery. What constitutes a "failed" IOL will be dictated by local clinical practice guidelines and will be informed by the time since IOL (24-48 hours) and/or physician diagnosis of labour dystocia. |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Recruitment Rate | The pilot trial will be considered feasible if least 75% of the target sample can be recruited after 24 months of recruitment. The number of screened, approached, consented and randomized individuals will be recorded to assess feasibility. Recruitment rate will be measured by the proportion of eligible participants enrolled (consented and randomized) into the study. | Within 24 months of randomizing the first participant |
| Measure | Description | Time Frame |
|---|---|---|
| Appropriateness of eligibility criteria | The appropriateness of the eligibility criteria will be assessed. This will be measured as the proportion of screened participants who are excluded overall and per exclusion criterion. It will be reported as numbers (n) and percentages (%). | Within 24 months of randomizing the first participant |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Malia Murphy, PhD | Contact | 613-737-8899 | malmurphy@ohri.ca | |
| Serine Ramlawi, MSc | Contact | 613-737-8899 | 73840 | sramlawi@ohri.ca |
| Name | Affiliation | Role |
|---|---|---|
| Mark C Walker, MD, MSc, MHM | Ottawa Hospital Research Institute | Principal Investigator |
| Darine El-Chaâr, MD, FRCS(C), MSc | Ottawa Hospital Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ottawa Hospital | Recruiting | Ottawa | Ontario | K1H 8L6 | Canada |
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This is a multi-centre Prospective Randomized Open-label Blinded Endpoint (PROBE) Pilot Trial
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| Participant retention |
Participant retention will be assessed. This will be measured as the rate of loss to follow-up or withdrawal of consent from randomized participants. It will be reported as numbers (n) and percentages (%). |
| Within 24 months of randomizing the first participant |
| Non-compliance | Participant and healthcare provider non-compliance will be assessed. This will be measured as the proportion of participants who receive off-protocol delivery management, including late IOL. It will be reported as numbers (n) and percentages (%). | Within 24 months of randomizing the first participant |
| Participant satisfaction | Participant satisfaction with participating in this study will be assessed. This will be assessed via established surveys: The Labour Agentry Scale, the Study Participant Feedback Questionnaire and the Decisional Regret Scale. | Within 24 months of randomizing the first participant |
| Suitability of maternal and neonatal clinical endpoints. | Suitability of maternal and neonatal clinical endpoints for an eventual full-scale trial will be assessed. This will be assessed based on expert consultation (clinical experts and individuals with lived experience) and will account for the rate of occurrence of severe maternal and neonatal outcomes, and quality and completeness of collected data. | Within 24 months of randomizing the first participant |
| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D007751 | Labor, Induced |
| D020360 | Neoadjuvant Therapy |
| ID | Term |
|---|---|
| D036861 | Delivery, Obstetric |
| D013513 | Obstetric Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
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