Gestational Diabetes
Conditions
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).
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.
Interventions
DIAGNOSTIC_TESTIADPSG Criteria
One-step: 2 hr 75 gr OGTT
DIAGNOSTIC_TESTNDDG Criteria
Osullivan test + 3 h 100 g OGTT
Sponsors
Hospital Mutua de Terrassa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Large for gestational age | At birth of infant | Infant birthweight \>90th centile using customized growth curves |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Small for gestational age | At birth of infant | infant birthweight \<10th centile using customized growth curves |
| Hypertension in pregnant | First 3 months postpartum | classification according to American College of Obstetricians and Gynecologists (Task Force on Hypertension in Pregnancy). |
| Neonatal obstetric trauma | At birth of infant | rate of shoulder dystocia, clavicle fracture, brachial plexus injury and intrapartum asphyxia |
| Congenital anomalies | At birth of infant | Coding of EUROCAT |
| Neonatal hypoglycemia | up to 4 weeks after delivery | neonatal plasma glucose levels of \<2.5 mmol/L in the first 24 hours of life and \<2.8 mmol/L thereafter. |
| Neonatal hypocalcemia | up to 4 weeks after delivery | neonatal calcium levels of \<7mg/dl |
| Neonatal hyperbilirubinemia | up to 4 weeks after delivery | hyperbilirubinemia treated with phototherapy |
| Neonatal polycythemia | up to 4 weeks after delivery | hematocrit from a peripheral venous sample is \>65 percent |
| Respiratory Distress Syndrome | up to 4 weeks after delivery | onset of progressive respiratory failure shortly after birth, in conjunction with a characteristic chest radiograph (after ruling out other causes). |
| Infant Outcomes | up to 4 weeks after delivery | Pregnancy loss (Miscarriage, stillbirth, neonatal death) |
| Macrosomia | At birth of infant | infant birthweight \>=4kg |
| Polyhydramnios | At birth of infant | Amniotic fluid index ≥25 cm |
| Gestational age at delivery | At birth of infant | Gestational age was defined as completed weeks based on last menstrual period or the earliest ultrasound assessment if discordant. |
| Cesarean section | At birth of infant | delivery of a baby through a surgical incision in the mother's abdomen and uterus |
| Perinatal mortality | First 7days postpartum | infant deaths that occur at less than 7 days of age and fetal deaths with a gestational age of 28 weeks or more. |
| NICU admission | up to 4 weeks after delivery | NICU admission for treatment or surveillance |
| Maternal hospital stay | up to 4 weeks from maternal discharge | Length of hospital stay (days) |
| Neonatal hospital stay | up to 4 weeks from neonatal discharge | Length of hospital stay (days) |
| Evaluation of mediterranean diet adherence | up to 12-14weeks from last menstrual period. | using Mediterranean Diet Adherence Screener (MEDAS) questionnaire. Score betwwen 0-14; high score indicate maximum mediterranean diet adherence. |
| Evaluation of health-related physical activity | up to 12-14weeks from last menstrual period. | 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) |
| Medical cost | First 3 months postpartum | 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 (€). |
| Hypertrophic cardiomyopathy | up to 4 weeks after delivery | increased left ventricular (LV) wall thickness ≥15 mm is imaged anywhere in the LV wall (by transthoracic echocardiography) |
Countries
Spain
Contacts
Primary ContactVerónica Perea, MD
Outcome results
None listed