Pregnancy Outcomes and Medical Costs According to Gestational Diabetes Mellitus Diagnostic Criteria: Randomized Prospective Study.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Gestational Diabetes
- Sponsor
- Hospital Mutua de Terrassa
- Enrollment
- 3644
- Locations
- 1
- Primary Endpoint
- Large for gestational age
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Large for gestational age
Time Frame: At birth of infant
Infant birthweight \>90th centile using customized growth curves
Secondary Outcomes
- Congenital anomalies(At birth of infant)
- Macrosomia(At birth of infant)
- Small for gestational age(At birth of infant)
- Hypertension in pregnant(First 3 months postpartum)
- Neonatal obstetric trauma(At birth of infant)
- Neonatal hypoglycemia(up to 4 weeks after delivery)
- Neonatal hypocalcemia(up to 4 weeks after delivery)
- Neonatal hyperbilirubinemia(up to 4 weeks after delivery)
- Neonatal polycythemia(up to 4 weeks after delivery)
- Respiratory Distress Syndrome(up to 4 weeks after delivery)
- Infant Outcomes(up to 4 weeks after delivery)
- Hypertrophic cardiomyopathy(up to 4 weeks after delivery)
- Polyhydramnios(At birth of infant)
- Gestational age at delivery(At birth of infant)
- Cesarean section(At birth of infant)
- Perinatal mortality(First 7days postpartum)
- NICU admission(up to 4 weeks after delivery)
- Maternal hospital stay(up to 4 weeks from maternal discharge)
- Neonatal hospital stay(up to 4 weeks from neonatal discharge)
- Evaluation of mediterranean diet adherence(up to 12-14weeks from last menstrual period.)
- Evaluation of health-related physical activity(up to 12-14weeks from last menstrual period.)
- Medical cost(First 3 months postpartum)