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

NCT03421262 | Unknown

• 1 other identifier: 00003
• Study Type: interventional
• Target: 3,644
• Locations: 1 country
• Sites: 1

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).

Conditions

Gestational Diabetes

Outcome Measures

Primary Outcomes (1)

• Large for gestational age

  Infant birthweight \>90th centile using customized growth curves

  At birth of infant

Secondary Outcomes (22)

• Macrosomia

  At birth of infant

• Small for gestational age

  At birth of infant

• Hypertension in pregnant

  First 3 months postpartum

• Neonatal obstetric trauma

  At birth of infant

• Congenital anomalies

  At birth of infant

Study Arms (2)

One-step:IADPSG Criteria

EXPERIMENTAL

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.

Diagnostic Test: IADPSG Criteria

Two-step:NDDG Criteria

ACTIVE COMPARATOR

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

Diagnostic Test: NDDG Criteria

Interventions

IADPSG Criteria DIAGNOSTIC_TEST

One-step: 2 hr 75 gr OGTT

One-step:IADPSG Criteria

NDDG Criteria DIAGNOSTIC_TEST

Osullivan test + 3 h 100 g OGTT

Two-step:NDDG Criteria

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Mutua de Terrassa: lead

Study Sites (1)

Hospital Universitari Mutua Terrassa

Terrassa, Barcelona, 08221, Spain

RECRUITING

Related Publications (1)

• 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.

  PMID: 18463375 BACKGROUND

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Verónica Perea, MD

  Hospital Universitari Mutua Terrassa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Verónica Perea, MD

CONTACT

0034937365050; vperea@mututaterrassa.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: February 5, 2018
• Study Start: June 1, 2017
• Primary Completion: November 27, 2018
• Study Completion: December 1, 2019
• Last Updated: February 5, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)