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

NCT ID: NCT03421262

Last Updated: 2018-02-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 3644 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2019-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

One-step:IADPSG Criteria

Gestational diabetes screening with fasting 2 hour 75g. Receive a fasting 2 hour 75 gr oral glucose tolerance test and diagnosed based on the IADPSG which is if one or more values exceed the following diagnostic threshold: Fasting 92, 1-hour 180, or 2-hour 153 mg/dL.

Group Type: EXPERIMENTAL

IADPSG Criteria

Intervention Type: DIAGNOSTIC_TEST

One-step: 2 hr 75 gr OGTT

Two-step:NDDG Criteria

Step 1: Perform a 1h 50-g glucose load test (nonfasting. If the plasma glucose level measured 1 h after the load is 140 mg/dL, proceed to a 100-g OGTT.

Step 2: 100-g OGTT. The diagnosis of GDM is made if at least two of the following four plasma glucose levels(measured fasting and 1 h, 2 h, 3 h after the OGTT) are met or exceeded: 105mg/dl, 190mg/dl, 165mg/dl and 145mg/dl respectively

Group Type: ACTIVE_COMPARATOR

NDDG Criteria

Intervention Type: DIAGNOSTIC_TEST

Osullivan test + 3 h 100 g OGTT

Interventions

IADPSG Criteria

One-step: 2 hr 75 gr OGTT

Intervention Type: DIAGNOSTIC_TEST

NDDG Criteria

Osullivan test + 3 h 100 g OGTT

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Age 18-50 years
• No expectation that subject will be moving out of the area of the clinical center during the next year
• Informed Consent Form signed by the subject

Exclusion Criteria

• Preexisting type 1 or 2 diabetes
• Advanced HIV( on medications that cause hyperglycemia), severe liver disease, gastric bypass surgery or other illness/surgeries that preclude them from drinking the glucose solution.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital Mutua de Terrassa

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Verónica Perea, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitari Mutua Terrassa

Locations

Hospital Universitari Mutua Terrassa

Terrassa, Barcelona, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Verónica Perea, MD

Role: CONTACT

vperea@mututaterrassa.cat

0034937365050 ext. 11330

Facility Contacts

Verónica Perea, MD

Role: primary

vperea@mutuaterrassa.cat

0034937365050 ext. 11330

References

HAPO Study Cooperative Research Group; Metzger BE, Lowe LP, Dyer AR, Trimble ER, Chaovarindr U, Coustan DR, Hadden DR, McCance DR, Hod M, McIntyre HD, Oats JJ, Persson B, Rogers MS, Sacks DA. Hyperglycemia and adverse pregnancy outcomes. N Engl J Med. 2008 May 8;358(19):1991-2002. doi: 10.1056/NEJMoa0707943.

Reference Type: BACKGROUND

PMID: 18463375 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

00003

Identifier Type: -

Identifier Source: org_study_id