NCT03421262

Pregnancy Outcomes and Medical Costs According to Gestational Diabetes Mellitus Diagnostic Criteria

Pregnancy Outcomes and Medical Costs According to Gestational Diabetes Mellitus Diagnostic Criteria: Randomized Prospective Study.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,644 (estimated)
• Sponsor: Hospital Mutua de Terrassa · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The aim of the study is to evaluate differences in pregnancy outcomes and medical costs depending on gestational diabetes diagnostic criteria used (one vs two-step approach).

Detailed description

Due to Hyperglycemia and Adverse Pregnancy Outcomes study results, a new gestational diabetes mellitus (GDM) diagnostic criteria was defined using a one-step approach (75-g oral glucose tolerance test -OGTT-). However, not all scientific societies have accepted and have implanted this new diagnostic criteria. The lowest glycemia cut-off of this criteria regarding the two-step approach entails an increase in GDM incidence with discordant studies about its cost-effectivity. It will be assessed if pregnancy outcomes and medical costs are different depending on diagnostic criteria used.

Conditions

• Gestational Diabetes

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	IADPSG Criteria	One-step: 2 hr 75 gr OGTT
DIAGNOSTIC_TEST	NDDG Criteria	Osullivan test + 3 h 100 g OGTT

Timeline

• Start date: 2017-06-01
• Primary completion: 2018-11-27
• Completion: 2019-12-01
• First posted: 2018-02-05
• Last updated: 2018-02-05

Locations

1 site across 1 country: Spain