The Feasibility Of Expectant Management Versus Induction At 38 Weeks Among Individuals With Gestational Diabetes Mellitus: A Randomized Controlled Pilot Trial (EAGER Pilot Trial)
Recruiting
N/A
Interventional Study
Gestational Diabetes Mellitus (GDM)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 16 and older
- Sex
- Female
- Study type
- Interventional
- Purpose
- Other
- Participants needed
- 260 (estimated)
- Sponsor
- Ottawa Hospital Research Institute · Other
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About 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 w…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Diagnosis of GDM after 24 weeks of gestation, based on documented 1-step or 2-step screening and diagnostic tests for GDM.
* Singleton fetus at randomization.
* Confirmed live fetus within 24 hours prior to randomization.
* Gestational age between 36 weeks + 0 days and 38 week…
Contacts