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

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

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).

Study Overview

• Status: Unknown
• Conditions: Gestational Diabetes
• Intervention / Treatment: Diagnostic test: IADPSG Criteria; Diagnostic test: NDDG Criteria

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.

• Study Type: Interventional
• Enrollment (Anticipated): 3644
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Terrassa, Barcelona, Spain, 08221
      • Recruiting
      • Hospital Universitari Mutua Terrassa
      • Contact: Verónica Perea, MD; Phone Number: 11330 0034937365050; Email: vperea@mutuaterrassa.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Diagnostic test: IADPSG Criteria; One-step: 2 hr 75 gr OGTT
ACTIVE_COMPARATOR: 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	Diagnostic test: NDDG Criteria; Osullivan test + 3 h 100 g OGTT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Large for gestational age	Infant birthweight >90th centile using customized growth curves	At birth of infant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Macrosomia	infant birthweight >=4kg	At birth of infant
Small for gestational age	infant birthweight <10th centile using customized growth curves	At birth of infant
Hypertension in pregnant	classification according to American College of Obstetricians and Gynecologists (Task Force on Hypertension in Pregnancy).	First 3 months postpartum
Neonatal obstetric trauma	rate of shoulder dystocia, clavicle fracture, brachial plexus injury and intrapartum asphyxia	At birth of infant
Congenital anomalies	Coding of EUROCAT	At birth of infant
Neonatal hypoglycemia	neonatal plasma glucose levels of <2.5 mmol/L in the first 24 hours of life and <2.8 mmol/L thereafter.	up to 4 weeks after delivery
Neonatal hypocalcemia	neonatal calcium levels of <7mg/dl	up to 4 weeks after delivery
Neonatal hyperbilirubinemia	hyperbilirubinemia treated with phototherapy	up to 4 weeks after delivery
Neonatal polycythemia	hematocrit from a peripheral venous sample is >65 percent	up to 4 weeks after delivery
Respiratory Distress Syndrome	onset of progressive respiratory failure shortly after birth, in conjunction with a characteristic chest radiograph (after ruling out other causes).	up to 4 weeks after delivery
Infant Outcomes	Pregnancy loss (Miscarriage, stillbirth, neonatal death)	up to 4 weeks after delivery
Hypertrophic cardiomyopathy	increased left ventricular (LV) wall thickness ≥15 mm is imaged anywhere in the LV wall (by transthoracic echocardiography)	up to 4 weeks after delivery
Polyhydramnios	Amniotic fluid index ≥25 cm	At birth of infant
Gestational age at delivery	Gestational age was defined as completed weeks based on last menstrual period or the earliest ultrasound assessment if discordant.	At birth of infant
Cesarean section	delivery of a baby through a surgical incision in the mother's abdomen and uterus	At birth of infant
Perinatal mortality	infant deaths that occur at less than 7 days of age and fetal deaths with a gestational age of 28 weeks or more.	First 7days postpartum
NICU admission	NICU admission for treatment or surveillance	up to 4 weeks after delivery
Maternal hospital stay	Length of hospital stay (days)	up to 4 weeks from maternal discharge
Neonatal hospital stay	Length of hospital stay (days)	up to 4 weeks from neonatal discharge
Evaluation of mediterranean diet adherence	using Mediterranean Diet Adherence Screener (MEDAS) questionnaire. Score betwwen 0-14; high score indicate maximum mediterranean diet adherence.	up to 12-14weeks from last menstrual period.
Evaluation of health-related physical activity	using International Physical Activity Questionnaire (IPAQ). Data collected with IPAQ can be used as a continuous measure (Metabolic Equivalent of Task [MET]-minutes/week) or caterorical measure (low, moderate or high physical activity)	up to 12-14weeks from last menstrual period.
Medical cost	Economic cost include: laboratory costs; glucose bottles (50 g, 100 g and 75 g); pharmaceutical expenditure (exact insulin doses consumed, total pens, needles, strips); medical visits during pregnany and postpartum (endocrinologist,educational nurses, obstetrician and midwifes); total number of tests (ultrasonds, cardiotocography record); cost of intensive care unit admissions (Length of stay and complexity) and total hospital admission costs. All these variables will be expressed as cost (€).	First 3 months postpartum

Collaborators and Investigators

• Sponsor: Hospital Mutua de Terrassa
• Investigators: Principal Investigator: Verónica Perea, MD, Hospital Universitari Mutua Terrassa

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2017
• Primary Completion (ANTICIPATED): November 27, 2018
• Study Completion (ANTICIPATED): December 1, 2019

Study Registration Dates

• First Submitted: November 27, 2017
• First Submitted That Met QC Criteria: January 29, 2018
• First Posted (ACTUAL): February 5, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 5, 2018
• Last Update Submitted That Met QC Criteria: January 29, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Diabetes, Gestational
• Other Study ID Numbers: 00003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No