Clinical trial NCT03421262: Pregnancy Outcomes and Medical Costs According to Gestational Diabetes Mellitus Diagnostic Criteria
Official title: Pregnancy Outcomes and Medical Costs According to Gestational Diabetes Mellitus Diagnostic Criteria: Randomized Prospective Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gestational Diabetes
Lead sponsor: Hospital Mutua de Terrassa
Sponsor class: OTHER
First posted: 2018-02-05
Enrollment: 3644
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Large for gestational age
timeFrame: At birth of infant
Secondary outcomes:
measure: Macrosomia
timeFrame: At birth of infant
measure: Small for gestational age
timeFrame: At birth of infant
measure: Hypertension in pregnant
timeFrame: First 3 months postpartum
measure: Neonatal obstetric trauma
timeFrame: At birth of infant
measure: Congenital anomalies
timeFrame: At birth of infant
measure: Neonatal hypoglycemia
timeFrame: up to 4 weeks after delivery
measure: Neonatal hypocalcemia
timeFrame: up to 4 weeks after delivery
measure: Neonatal hyperbilirubinemia
timeFrame: up to 4 weeks after delivery
measure: Neonatal polycythemia
timeFrame: up to 4 weeks after delivery
measure: Respiratory Distress Syndrome
timeFrame: up to 4 weeks after delivery
measure: Infant Outcomes
timeFrame: up to 4 weeks after delivery
measure: Hypertrophic cardiomyopathy
timeFrame: up to 4 weeks after delivery
measure: Polyhydramnios
timeFrame: At birth of infant
measure: Gestational age at delivery
timeFrame: At birth of infant
measure: Cesarean section
timeFrame: At birth of infant
measure: Perinatal mortality
timeFrame: First 7days postpartum
measure: NICU admission
timeFrame: up to 4 weeks after delivery
measure: Maternal hospital stay
timeFrame: up to 4 weeks from maternal discharge
measure: Neonatal hospital stay
timeFrame: up to 4 weeks from neonatal discharge
measure: Evaluation of mediterranean diet adherence
timeFrame: up to 12-14weeks from last menstrual period.
measure: Evaluation of health-related physical activity
timeFrame: up to 12-14weeks from last menstrual period.
measure: Medical cost
timeFrame: First 3 months postpartum
Other outcomes:
Locations:
city: Terrassa
country: Spain
facility: Hospital Universitari Mutua Terrassa
state: Barcelona
Study officials:
affiliation: Hospital Universitari Mutua Terrassa
name: Verónica Perea, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: HAPO Study Cooperative Research Group; Metzger BE, Lowe LP, Dyer AR, Trimble ER, Chaovarindr U, Coustan DR, Hadden DR, McCance DR, Hod M, McIntyre HD, Oats JJ, Persson B, Rogers MS, Sacks DA. Hyperglycemia and adverse pregnancy outcomes. N Engl J Med. 2008 May 8;358(19):1991-2002. doi: 10.1056/NEJMoa0707943.