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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IADPSG Criteria | Diagnostic Test | One-step: 2 hr 75 gr OGTT |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Large for gestational age | Infant birthweight >90th centile using customized growth curves | At birth of infant |
| Measure | Description | Time Frame |
|---|---|---|
| Macrosomia | infant birthweight >=4kg | At birth of infant |
| Small for gestational age | infant birthweight <10th centile using customized growth curves |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Verónica Perea, MD | Contact | 0034937365050 | 11330 | vperea@mututaterrassa.cat |
| Name | Affiliation | Role |
|---|---|---|
| Verónica Perea, MD | Hospital Mutua de Terrassa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Mutua Terrassa | Recruiting | Terrassa | Barcelona | 08221 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18463375 | Background | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 8, 2018 | Jan 8, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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| NDDG Criteria |
| Diagnostic Test |
Osullivan test + 3 h 100 g OGTT |
|
| 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 |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |