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TANGO-DM: Randomized trial of effective treatment according to new GDM criteria

TANGO-DM: Randomized trial of effective treatment according to new GDM criteria - TANGO-DM

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON52951
Enrollment
1032
Registered
2018-08-14
Start date
2018-10-04
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

diabetes in pregnancy GDM gestational diabetes

Interventions

The intervention is intensive GDM treatment, including monitoring of blood glucose values, dietary recommendations and pharmacotherapy for those unable to achieve euglycemia with dietary interventio

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Singleton pregnancy - Aged >18 years - OGTT for all indications - OGTT conducted between gestational ages 16+0 and 30+ 0 weeks - Discordant result on a 3-point 75-gram OGTT i.e.: o Fasting glucose > 5.1 and =10.0 mmol/l OR o 2-hour glucose >7.8 and

Exclusion criteria

Exclusion criteria: - known preconception diabetes - major fetal congenital /chromosomal abnormality (eg trisomy 21, spina bifida), known at time of randomization - significant medical or psychiatric co-morbidities as judged by the investigator (e.g. high dose corticosteroid treatment) - inability to understand written informed consent without help as indicated by their usual care provider

Design outcomes

Primary

MeasureTime frame
The primary outcome will be the incidence of birth weight >90th centile (LGA).

Secondary

MeasureTime frame
Secondary outcomes include mode of delivery (caesarean sections), maternal outcomes, perinatal outcomes including perinatal mortality, gestational age at delivery, shoulder dystocia, birth trauma, neonatal hypoglycaemia, neonatal intensive care admission, need for phototherapy, quality of life and societal costs.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)