Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06641141
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-11
Brief Title:
The Feasibility Of Expectant Management Versus Induction At 38 Weeks Among Individuals With Gestational Diabetes Mellitus A Randomized Controlled Pilot Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Feasibility Of Expectant Management Versus Induction At 38 Weeks Among Individuals With Gestational Diabetes Mellitus A Randomized Controlled Pilot Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EAGER Pilot
Brief Summary:
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 37 weeks 0 days and 38 weeks 2 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 will be collected as will clinical data from medical charts and a blood sample to assess glycemic control 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
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 will be collected as will clinical data from medical charts and a blood sample to assess glycemic control 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None