Pregnancy Outcomes and Medical Costs According to Gestational Diabetes Mellitus Diagnostic Criteria (POMEC)
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|ClinicalTrials.gov Identifier: NCT03421262|
Recruitment Status : Recruiting
First Posted : February 5, 2018
Last Update Posted : February 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Gestational Diabetes||Diagnostic Test: IADPSG Criteria Diagnostic Test: NDDG Criteria||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||3644 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pregnancy Outcomes and Medical Costs According to Gestational Diabetes Mellitus Diagnostic Criteria: Randomized Prospective Study.|
|Actual Study Start Date :||June 1, 2017|
|Estimated Primary Completion Date :||November 27, 2018|
|Estimated Study Completion Date :||December 2019|
Experimental: One-step: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.
Diagnostic Test: IADPSG Criteria
One-step: 2 hr 75 gr OGTT
Active Comparator: Two-step: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
Diagnostic Test: NDDG Criteria
Osullivan test + 3 h 100 g OGTT
- Large for gestational age [ Time Frame: At birth of infant ]Infant birthweight >90th centile using customized growth curves
- Macrosomia [ Time Frame: At birth of infant ]infant birthweight >=4kg
- Small for gestational age [ Time Frame: At birth of infant ]infant birthweight <10th centile using customized growth curves
- Hypertension in pregnant [ Time Frame: First 3 months postpartum ]classification according to American College of Obstetricians and Gynecologists (Task Force on Hypertension in Pregnancy).
- Neonatal obstetric trauma [ Time Frame: At birth of infant ]rate of shoulder dystocia, clavicle fracture, brachial plexus injury and intrapartum asphyxia
- Congenital anomalies [ Time Frame: At birth of infant ]Coding of EUROCAT
- Neonatal hypoglycemia [ Time Frame: 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 [ Time Frame: up to 4 weeks after delivery ]neonatal calcium levels of <7mg/dl
- Neonatal hyperbilirubinemia [ Time Frame: up to 4 weeks after delivery ]hyperbilirubinemia treated with phototherapy
- Neonatal polycythemia [ Time Frame: up to 4 weeks after delivery ]hematocrit from a peripheral venous sample is >65 percent
- Respiratory Distress Syndrome [ Time Frame: 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 [ Time Frame: up to 4 weeks after delivery ]Pregnancy loss (Miscarriage, stillbirth, neonatal death)
- Hypertrophic cardiomyopathy [ Time Frame: 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 [ Time Frame: At birth of infant ]Amniotic fluid index ≥25 cm
- Gestational age at delivery [ Time Frame: 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 [ Time Frame: At birth of infant ]delivery of a baby through a surgical incision in the mother's abdomen and uterus
- Perinatal mortality [ Time Frame: 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 [ Time Frame: up to 4 weeks after delivery ]NICU admission for treatment or surveillance
- Maternal hospital stay [ Time Frame: up to 4 weeks from maternal discharge ]Length of hospital stay (days)
- Neonatal hospital stay [ Time Frame: up to 4 weeks from neonatal discharge ]Length of hospital stay (days)
- Evaluation of mediterranean diet adherence [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 (€).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03421262
|Contact: Verónica Perea, MD||0034937365050 ext email@example.com|
|Hospital Universitari Mutua Terrassa||Recruiting|
|Terrassa, Barcelona, Spain, 08221|
|Contact: Verónica Perea, MD 0034937365050 ext 11330 firstname.lastname@example.org|
|Principal Investigator:||Verónica Perea, MD||Hospital Universitari Mutua Terrassa|