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

Hospital Mutua de Terrassa3,644 enrolled

Overview

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).

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

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

3,644

Conditions

Gestational Diabetes

Interventions

IADPSG CriteriaDIAGNOSTIC_TEST

One-step: 2 hr 75 gr OGTT

NDDG CriteriaDIAGNOSTIC_TEST

Osullivan test + 3 h 100 g OGTT

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Hospital Universitari Mutua Terrassa

Terrassa, Barcelona, Spain

RECRUITING

Outcomes

Primary Outcomes

Large for gestational age

Infant birthweight \>90th centile using customized growth curves

Time frame: At birth of infant

Secondary Outcomes

Macrosomia

infant birthweight \>=4kg

Time frame: At birth of infant

Small for gestational age

infant birthweight \<10th centile using customized growth curves

Time frame: At birth of infant

Hypertension in pregnant

classification according to American College of Obstetricians and Gynecologists (Task Force on Hypertension in Pregnancy).

Time frame: First 3 months postpartum

Neonatal obstetric trauma

rate of shoulder dystocia, clavicle fracture, brachial plexus injury and intrapartum asphyxia

Time frame: At birth of infant

Congenital anomalies

Coding of EUROCAT

Time frame: 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.

Time frame: up to 4 weeks after delivery

Neonatal hypocalcemia

neonatal calcium levels of \<7mg/dl

Time frame: up to 4 weeks after delivery

Neonatal hyperbilirubinemia

Central Contacts

Verónica Perea, MD

CONTACT

0034937365050 vperea@mututaterrassa.cat

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

hyperbilirubinemia treated with phototherapy

Time frame: up to 4 weeks after delivery

Neonatal polycythemia

hematocrit from a peripheral venous sample is \>65 percent

Time frame: 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).

Time frame: up to 4 weeks after delivery

Infant Outcomes

Pregnancy loss (Miscarriage, stillbirth, neonatal death)

Time frame: 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)

Time frame: up to 4 weeks after delivery

Polyhydramnios

Amniotic fluid index ≥25 cm

Time frame: 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.

Time frame: At birth of infant

Cesarean section

delivery of a baby through a surgical incision in the mother's abdomen and uterus

Time frame: 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.

Time frame: First 7days postpartum

NICU admission

NICU admission for treatment or surveillance

Time frame: up to 4 weeks after delivery

Maternal hospital stay

Length of hospital stay (days)

Time frame: up to 4 weeks from maternal discharge

Neonatal hospital stay

Length of hospital stay (days)

Time frame: 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.

Time frame: 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)

Time frame: 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 (€).

Time frame: First 3 months postpartum