Pregnancy Outcomes and Medical Costs According to Gestational Diabetes Mellitus Diagnostic Criteria

Not Applicable

• Conditions: Gestational Diabetes

• 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.

Study Timeline

• Study Start: 2017-06-01
• Study First Submitted: 2017-11-27
• Status Verified: 2018-01
• Study First Submitted QC: 2018-01-29
• Last Update Submitted: 2018-01-29
• Study First Posted: 2018-02-05
• Last Update Posted: 2018-02-05
• Primary Completion: 2018-11-27
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 3644

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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
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.
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)
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