Impact on pregnancy outcomes when changing diagnostic criteria for gestational diabetes in Sweden
Impact of Changing Diagnostic criteria for Gestional diabetes in Sweden - a national stepped wedge randomized controlled trial
- Registry ID
- ISRCTN41918550
- Source registry
- ISRCTN
- Status
- No longer recruiting
- Study type
- INTERVENTIONAL
- Sponsor
- Region Örebro County
- Enrollment
- 71500
- Start date
- 2018-01-01
- Completion date
- 2025-12-31
- Last update
- 2026-08-17
Conditions
- Pregnancy and Childbirth
- Gestational diabetes mellitus
Summary
Gestational diabetes mellitus
Detailed description
The intervention is the switch from the pre-existing Swedish diagnostic criteria to the WHO 2013 criteria for GDM to the 3 point OGTT with fasting, 1 hour and/or 2 hour diagnostic thresholds of ≥5.1, ≥10.0, ≥8.5 mmol/l. This stepped wedge randomised controlled study design allows each participating center (cluster) to be their own controls before and after randomization. All eligible women from the participating centres are randomised for starting time to the new regime. Randomisation is done through a RCT module from the Pregnancy Register.
Interventions
- OTHER: The intervention is the switch from the pre-existing Swedish diagnostic criteria to the WHO 2013 criteria for GDM to the 3 point OGTT with fasting, 1 hour and/or 2 hour diagnostic thresholds of ≥5.1, ≥10.0, ≥8.5 mmol/l. This stepped wedge randomised controlled study design allows each participating center (cluster) to be their own controls before and after randomization. All eligible women from the participating centres are randomised for starting time to the new regime. Randomisation is done t
Inclusion criteria
All pregnant women in the participating hospitals and their uptake regions.
Exclusion criteria
Preexisting diabetes mellitus.
Locations
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