Pregnancy Outcomes and Medical Costs According to Gestational Diabetes Mellitus Diagnostic Criteria
- Conditions
- Gestational Diabetes
- Interventions
- Diagnostic Test: IADPSG CriteriaDiagnostic Test: NDDG Criteria
- Registration Number
- NCT03421262
- Lead Sponsor
- Hospital Mutua de Terrassa
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 3644
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description One-step:IADPSG Criteria 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. Two-step:NDDG Criteria 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
- Primary Outcome Measures
Name Time Method Large for gestational age At birth of infant Infant birthweight \>90th centile using customized growth curves
- Secondary Outcome Measures
Name Time Method Macrosomia At birth of infant infant birthweight \>=4kg
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)
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)
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 (€).
Trial Locations
- Locations (1)
Hospital Universitari Mutua Terrassa
🇪🇸Terrassa, Barcelona, Spain