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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Gestational Diabetes

Intervention / Treatment
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* Diagnostic Test: IADPSG Criteria
* Diagnostic Test: NDDG Criteria


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: One-step:IADPSG Criteria<br>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<br>* One-step: 2 hr 75 gr OGTT<br>|
| Active Comparator: Two-step:NDDG Criteria<br>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<br>* Osullivan test + 3 h 100 g OGTT<br>|

What is the study measuring?
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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 |