Pregnancy Outcomes and Medical Costs According to Gestational Diabetes Mellitus Diagnostic Criteria: Randomized Prospective Study.
Phase: NA
Conditions: Gestational Diabetes
Sponsor: Hospital Mutua de Terrassa

 
 
 
 
 
 
 
 
Pregnancy outcomes and medical costs according to 
gestational diabetes mellitus diagnostic criteria: 
randomized prospective study. POMEC study. 
 
 
 
 
 
 
 
Protocol ID: 00003 
 
Approval Number: 11/09/2016 
 
 
Version: 8th January 2018 
 

POMEC STUDY        Protocol ID:00003 
8th January 2018 
2 
 
 
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-) 1 
 
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 2–4. 
 
It will be assessed if pregnancy outcomes and medical costs are different depending 
on diagnostic criteria used. 
 
RESEARCH DESIGN AND METHODS 
 
The POMEC study is a randomized, parallel group trial, conducted in Spain. The Ethics 
Committee at Hospital Universitari Mútua Terrassa (Spain) approved the study. 
 
Participants: 
All pregnant women with follow-up of their gestation at Hospital Universitari Mútua 
Terrassa (Spain), at first antenatal visit, will be proposed to participate in the study.  
 
Inclusion Criteria: 
- Age 18-50 years 
- No expectation that the participant will be moving out of the area of the clinical centre 
during the next year 
- Informed Consent Form signed by the subject 
 
Exclusion Criteria: 
- Pre-existing type 1 or 2 diabetes 
- Advanced human immunodeficiency virus infection (on medications that cause 
hyperglycemia), 
severe 
liver 
disease, 
gastric 
bypass 
surgery 
or 
other 
illnesses/surgeries that preclude them from drinking the glucose solution. 
 
 
Randomization: 
 
All pregnant women without a former diagnosis of diabetes mellitus will be considered 
for gestational diabetes mellitus (GDM) screening at 24–28 weeks of gestation.  
 
Women with risk factors for diabetes at their initial prenatal visit will be screening at 9-
12 weeks of gestation. Risk factors are:  Age >35years, obesity (body mass index 
≥30kg/m2 or >27.5kg/m2 in Asian Americans), first-degree relative with diabetes and 
high-risk race/ethnicity (e.g., African American, Latino, Native American, Asian 
American, Pacific Islander).  
 

POMEC STUDY        Protocol ID:00003 
8th January 2018 
3 
 
At the time of GDM screening, patients will be assigned a number by a random number 
generation program (ratio 1: 1) that will classify them to one of the following two 
groups: 
- Experimental Group (One-step): International Association of Diabetes and Pregnancy 
Study Groups (IADPSG) Criteria. 
Perfoming a fasting 2 hour 75g OGTT. The diagnosis of GDM is made if at least one or 
more values are ≥: Fasting 92, 1-hour 180, or 2-hour 153 mg/dL. 
 
- Active Comparator (Two-step): National Diabetes Data Group (NDDG) Criteria 
Step 1: Performing 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, 1 h, 2 h, 3 h after the OGTT) are ≥: 
105mg/dl, 190mg/dl, 165mg/dl and 145mg/dl respectively.  
If only one value is exceed, 100g OGTT will be repeated 2-3weeks after.  
 
Pregnant women without GDM diagnosis at third trimester of pregnancy will repeat 
GDM screening (according previous randomization) if it appears macrosomia or/and 
polyhydramnios in the follow-up.  
 
GDM diagnosed women will be managed with diet and self-monitoring of blood 
glucose. Insulin will be added according to the local protocol5. All women will receive 
routine prenatal care (without differences between randomized groups).  
 
Outcomes 
Primary outcome Measures:  
Large for gestational age (LGA): Infant birthweight >90th centile using customized 
growth curves. Time Frame: At birth of infant. 
Secondary Outcome Measures: 
1. Infant outcomes 
- Small for gestational age (infant birthweight <10th centile using customized growth 
curves); macrosomia (infant birthweight >=4kg), Neonatal obstetric trauma (shoulder 
dystocia, clavicle fracture, brachial plexus injury, intrapartum asphyxia), Congenital 
anomalies (Coding of EUROCAT), Pregnancy loss (Miscarriage, stillbirth, neonatal 
death) 
Time Frame: At birth of infant  
- Neonatal hypoglycaemia (neonatal plasma glucose levels <2.5 mmol/L in the first 24 
hours of life and <2.8 mmol/L thereafter), Neonatal hypocalcemia (neonatal calcium 
levels <7mg/dl), Neonatal hyperbilirubinemia (hyperbilirubinemia treated with 
phototherapy), Neonatal polycythemia (hematocrit from a peripheral venous sample 
>65 percent), Respiratory Distress Syndrome (onset of progressive respiratory failure 
shortly after birth, in conjunction with a characteristic chest radiograph -after ruling out 
other causes-), Hypertrophic cardiomyopathy (increased left ventricular –LV- wall 

POMEC STUDY        Protocol ID:00003 
8th January 2018 
4 
 
thickness 
≥15 
mm 
imaged 
anywhere 
in 
the 
LV 
wall 
-by 
transthoracic 
echocardiography-), NICU admission (NICU admission for treatment or surveillance), 
neonatal hospital stay (Length of hospital stay –days-). 
Time Frame: at infant hospital discharge. 
- Perinatal mortality (infant deaths that happen at less than 7 days of age and fetal 
deaths with a gestational age of 28 weeks or more). Time Frame: First 7 days 
postpartum. 
2. Maternal outcomes 
-Hypertension in pregnant: worsening of chronic hypertension, gestational hypertension 
and preeclampsia. Time Frame: First 3 months postpartum 
- Polyhydramnios (Amniotic fluid index ≥25 cm). Time Frame: At birth of infant. 
- Cesarean section delivery of a baby through a surgical incision in the mother's 
abdomen and uterus. Time Frame: At birth of infant. 
- Maternal hospital stay: Length of hospital stay (days).  Time Frame: at maternal 
hospital discharge. 
- Questionnaires:  Evaluation of Mediterranean diet adherence using Mediterranean 
Diet Adherence Screener (MEDAS) questionnaire. Evaluation of health-related physical 
activity using IPAQ questionnaire. Time Frame: up to 12-14weeks from last menstrual 
period. 
3. Gestational age at delivery: Gestational age was defined as completed weeks based 
on last menstrual period or the earliest ultrasound assessment if discordant. Time 
Frame: At birth of infant.  
4. 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 pregnancy and postpartum (endocrinologist, 
educational nurses, obstetrician and midwifes); total number of tests (ultrasounds, 
cardiotocography records); cost of intensive care unit admissions (Length of stay and 
complexity) and total hospital admission costs. Time Frame: First 3 months postpartum 
  
Statistical analysis 
 
Sample size (n=3,644) was calculated to detect a 20% decrease rate of LGA (primary 
outcome), assuming baseline rate of 16.5% (α=0.05 and β=0.80). This decrease rate 
was obtained from St Carlos Gestational Diabetes 
Study, carried out in Spanish 
population which compared Carpeten-Coustan criteria vs IADPSG criteria3. Since we 
will use NDDG criteria (vs. IADPSG), baseline LGA incidence was obtained from 
Spanish Multicentre Study6.  
 

POMEC STUDY        Protocol ID:00003 
8th January 2018 
5 
 
Results will be presented as means ± standard deviation in normal distribution, median 
[interquartile interval (IQI)] in non‐normal distribution or percentages. Normal 
distribution will be tested for each variable using the Kolmogorov test.  
 
Student t test will be used for normally distributed variables and the Mann‐Whitney U 
test for non‐normally distributed variables between two independent groups. 
Proportions will be compared using a Pearson's chi‐square or Fisher exact test as 
appropriate.  
 
We will use logistic regression analyses or multivariate linear regression (as 
appropriate) to estimate the ratio of the probability [I-TDS(1]of occurrence of an adverse 
event (primary and secondary outcomes) with 95% CIs by experimental group versus 
control group adjusting for cofounding factors (age, smoke habit, weight, multiparity) 
P values <0.05 were considered statistically significant. All statistical calculations will 
be performed with the STATA 14.0 statistical package.  
 
 
REFERENCES 
 
1. 
Metzger, B. E. et al. Hyperglycemia and adverse pregnancy outcomes. N. Engl. 
J. Med. 358, 1991–2002 (2008). 
2. 
Meltzer, S. J., Snyder, J., Penrod, J. R., Nudi, M. & Morin, L. Gestational 
diabetes mellitus screening and diagnosis: A prospective randomised controlled 
trial comparing costs of one-step and two-step methods. BJOG An Int. J. Obstet. 
Gynaecol. (2010). doi:10.1111/j.1471-0528.2009.02475.x 
3. 
Duran, A. et al. Introduction of IADPSG criteria for the screening and diagnosis 
of gestational diabetes mellitus results in improved pregnancy outcomes at a 
lower cost in a large cohort of pregnant women: the St. Carlos Gestational 
Diabetes Study. Diabetes Care 37, 2442–50 (2014). 
4. 
Corcoy, R., Lumbreras, B., Bartha, J. L., Ricart, W. & Grupo Español de 
Diabetes y Embarazo. New diagnostic criteria for gestational diabetes mellitus 
after the HAPO study. Are they valid in our environment?. Endocrinol. Nutr. 57, 

POMEC STUDY        Protocol ID:00003 
8th January 2018 
6 
 
277–80 
5. 
Asistencia a la gestante con diabetes. Guía de práctica clínica actualizada en 
2014. Av. en Diabetol. 31, 45–59 (2015). 
6. 
Ricart, W. et al.  Potential impact of American Diabetes Association (2000) 
criteria for diagnosis of gestational diabetes mellitus in Spain. Diabetologia 48, 
1135–41 (2005).