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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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN41918550
Enrollment
71500
Registered
2017-12-15
Start date
2018-01-01
Completion date
Unknown
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational diabetes mellitus Pregnancy and Childbirth Gestational diabetes mellitus

Interventions

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,

Sponsors

Region Örebro County
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: All pregnant women in the participating hospitals and their uptake regions.

Exclusion criteria

Exclusion criteria: Preexisting diabetes mellitus.

Design outcomes

Primary

MeasureTime frame
Large for Gestational Age (LGA) is measured as the weight of the baby will be measured at time of birth.

Secondary

MeasureTime frame
Current secondary outcome measures as of 28/02/2019 in accordance with approved ethical protocol from 07/12/2016: 1. Composite of severe adverse outcomes (stillbirth, neonatal death, Erbs palsy, metabolic acidosis defined as pH 12 mmol/l in umbilical artery or pH <7.0 in umbilical artery, Apgar score <4 at 5 minutes, HIE I-III, intracranial haemorrhage, neonatal convulsions, meconium aspiration syndrome, mechanical ventilation) 2. 5-Min Apgar score <7 3. Fractured clavicle 4. Blood glucose in the infants 5. Prematurity <37 weeks 6. NICU admission yes/no 7. NICU days 8. Small for Gestational Age 9. Health economic outcome 10. Incremental Cost Effectiveness Ratio 11. Hypoglycaemia needing IV therapy 12. Phototherapy 13. Blood glucose in the infants Maternal outcomes: 1. Hypertension, Pre-eclampsia-defined is measured using blood pressure and proteinuria at labour and/or discharge 2. Shoulder dystocia is measured using pregnancy quality register (Shoulder dystocia ICD O660) at labour and/or discharge 3. Perineal trauma-3 and 4 degree measured using pregnancy quality register (Perineal trauma ICD O70) at labour and/or discharge 4. Induction of labour is measured using medical records at labour 5. Breastfeeding at hospital discharge 6. Emergency C-section is measured using medical records at labour and/or discharge 7. Elective C-section is measured using medical records at labour and/or discharge 8. Instrumental delivery is recorded using medical records at labour and/or discharge 9. Length of maternal postnatal stay is recorded using medical records at discharge Previous secondary outcome measures: 1. Hypertension, Pre-eclampsia-defined is measured using blood pressure and proteinuria at labour and/or discharge 2. Shoulder dystocia is measured using pregnancy quality register (Shoulder dystocia ICD O660) at labour and/or discharge 3. Perineal trauma-3 and 4 degree measured using pregnancy quality register (Perineal trauma ICD O70) at labour and/or discharge 4. Indu

Countries

Sweden

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Aug 15, 2026