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

Gestational Diabetes Clinical Trial

— POMEC  

Official title:

Pregnancy Outcomes and Medical Costs According to Gestational Diabetes Mellitus Diagnostic Criteria: Randomized Prospective Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03421262
• Other study ID #: 00003
• Status: Recruiting
• Phase: N/A
• First received: November 27, 2017
• Last updated: January 29, 2018
• Start date: June 1, 2017
• Est. completion date: December 2019

Study information

• Verified date: January 2018
• Source: Hospital Mutua de Terrassa
• Contact: Verónica Perea, MD
• Phone: 0034937365050
• Email: vperea[@]mututaterrassa.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Recruiting
• Enrollment: 3644
• Est. completion date: December 2019
• Est. primary completion date: November 27, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes

Intervention

Diagnostic Test:
• IADPSG Criteria
One-step: 2 hr 75 gr OGTT
• NDDG Criteria
Osullivan test + 3 h 100 g OGTT

Locations

Country	Name	City	State
Spain	Hospital Universitari Mutua Terrassa	Terrassa	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Mutua de Terrassa

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Large for gestational age	Infant birthweight >90th centile using customized growth curves	At birth of infant
Secondary	Macrosomia	infant birthweight >=4kg	At birth of infant
Secondary	Small for gestational age	infant birthweight <10th centile using customized growth curves	At birth of infant
Secondary	Hypertension in pregnant	classification according to American College of Obstetricians and Gynecologists (Task Force on Hypertension in Pregnancy).	First 3 months postpartum
Secondary	Neonatal obstetric trauma	rate of shoulder dystocia, clavicle fracture, brachial plexus injury and intrapartum asphyxia	At birth of infant
Secondary	Congenital anomalies	Coding of EUROCAT	At birth of infant
Secondary	Neonatal hypoglycemia	neonatal plasma glucose levels of <2.5 mmol/L in the first 24 hours of life and <2.8 mmol/L thereafter.	up to 4 weeks after delivery
Secondary	Neonatal hypocalcemia	neonatal calcium levels of <7mg/dl	up to 4 weeks after delivery
Secondary	Neonatal hyperbilirubinemia	hyperbilirubinemia treated with phototherapy	up to 4 weeks after delivery
Secondary	Neonatal polycythemia	hematocrit from a peripheral venous sample is >65 percent	up to 4 weeks after delivery
Secondary	Respiratory Distress Syndrome	onset of progressive respiratory failure shortly after birth, in conjunction with a characteristic chest radiograph (after ruling out other causes).	up to 4 weeks after delivery
Secondary	Infant Outcomes	Pregnancy loss (Miscarriage, stillbirth, neonatal death)	up to 4 weeks after delivery
Secondary	Hypertrophic cardiomyopathy	increased left ventricular (LV) wall thickness =15 mm is imaged anywhere in the LV wall (by transthoracic echocardiography)	up to 4 weeks after delivery
Secondary	Polyhydramnios	Amniotic fluid index =25 cm	At birth of infant
Secondary	Gestational age at delivery	Gestational age was defined as completed weeks based on last menstrual period or the earliest ultrasound assessment if discordant.	At birth of infant
Secondary	Cesarean section	delivery of a baby through a surgical incision in the mother's abdomen and uterus	At birth of infant
Secondary	Perinatal mortality	infant deaths that occur at less than 7 days of age and fetal deaths with a gestational age of 28 weeks or more.	First 7days postpartum
Secondary	NICU admission	NICU admission for treatment or surveillance	up to 4 weeks after delivery
Secondary	Maternal hospital stay	Length of hospital stay (days)	up to 4 weeks from maternal discharge
Secondary	Neonatal hospital stay	Length of hospital stay (days)	up to 4 weeks from neonatal discharge
Secondary	Evaluation of mediterranean diet adherence	using Mediterranean Diet Adherence Screener (MEDAS) questionnaire. Score betwwen 0-14; high score indicate maximum mediterranean diet adherence.	up to 12-14weeks from last menstrual period.
Secondary	Evaluation of health-related physical activity	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)	up to 12-14weeks from last menstrual period.
Secondary	Medical cost	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 (€).	First 3 months postpartum