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

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ClinicalTrials.gov Identifier: NCT03421262
Recruitment Status : Recruiting
First Posted : February 5, 2018
Last Update Posted : February 5, 2018
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment
Gestational Diabetes Diagnostic Test: IADPSG Criteria Diagnostic Test: NDDG Criteria

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3644 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pregnancy Outcomes and Medical Costs According to Gestational Diabetes Mellitus Diagnostic Criteria: Randomized Prospective Study.
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : November 27, 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: One-step:IADPSG Criteria
Gestational diabetes screening with fasting 2 hour 75g. Receive a fasting 2 hour 75 gr oral glucose tolerance test and diagnosed based on the IADPSG which is if one or more values exceed the following diagnostic threshold: Fasting 92, 1-hour 180, or 2-hour 153 mg/dL.
Diagnostic Test: IADPSG Criteria
One-step: 2 hr 75 gr OGTT
Active Comparator: Two-step:NDDG Criteria

Step 1: Perform 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 and 1 h, 2 h, 3 h after the OGTT) are met or exceeded: 105mg/dl, 190mg/dl, 165mg/dl and 145mg/dl respectively

Diagnostic Test: NDDG Criteria
Osullivan test + 3 h 100 g OGTT



Primary Outcome Measures :
  1. Large for gestational age [ Time Frame: At birth of infant ]
    Infant birthweight >90th centile using customized growth curves


Secondary Outcome Measures :
  1. Macrosomia [ Time Frame: At birth of infant ]
    infant birthweight >=4kg

  2. Small for gestational age [ Time Frame: At birth of infant ]
    infant birthweight <10th centile using customized growth curves

  3. Hypertension in pregnant [ Time Frame: First 3 months postpartum ]
    classification according to American College of Obstetricians and Gynecologists (Task Force on Hypertension in Pregnancy).

  4. Neonatal obstetric trauma [ Time Frame: At birth of infant ]
    rate of shoulder dystocia, clavicle fracture, brachial plexus injury and intrapartum asphyxia

  5. Congenital anomalies [ Time Frame: At birth of infant ]
    Coding of EUROCAT

  6. Neonatal hypoglycemia [ Time Frame: 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.

  7. Neonatal hypocalcemia [ Time Frame: up to 4 weeks after delivery ]
    neonatal calcium levels of <7mg/dl

  8. Neonatal hyperbilirubinemia [ Time Frame: up to 4 weeks after delivery ]
    hyperbilirubinemia treated with phototherapy

  9. Neonatal polycythemia [ Time Frame: up to 4 weeks after delivery ]
    hematocrit from a peripheral venous sample is >65 percent

  10. Respiratory Distress Syndrome [ Time Frame: 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).

  11. Infant Outcomes [ Time Frame: up to 4 weeks after delivery ]
    Pregnancy loss (Miscarriage, stillbirth, neonatal death)

  12. Hypertrophic cardiomyopathy [ Time Frame: up to 4 weeks after delivery ]
    increased left ventricular (LV) wall thickness ≥15 mm is imaged anywhere in the LV wall (by transthoracic echocardiography)

  13. Polyhydramnios [ Time Frame: At birth of infant ]
    Amniotic fluid index ≥25 cm

  14. Gestational age at delivery [ Time Frame: At birth of infant ]
    Gestational age was defined as completed weeks based on last menstrual period or the earliest ultrasound assessment if discordant.

  15. Cesarean section [ Time Frame: At birth of infant ]
    delivery of a baby through a surgical incision in the mother's abdomen and uterus

  16. Perinatal mortality [ Time Frame: 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.

  17. NICU admission [ Time Frame: up to 4 weeks after delivery ]
    NICU admission for treatment or surveillance

  18. Maternal hospital stay [ Time Frame: up to 4 weeks from maternal discharge ]
    Length of hospital stay (days)

  19. Neonatal hospital stay [ Time Frame: up to 4 weeks from neonatal discharge ]
    Length of hospital stay (days)

  20. Evaluation of mediterranean diet adherence [ Time Frame: 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.

  21. Evaluation of health-related physical activity [ Time Frame: 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)

  22. Medical cost [ Time Frame: 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 (€).




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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03421262


Contacts
Contact: Verónica Perea, MD 0034937365050 ext 11330 vperea@mututaterrassa.cat

Locations
Spain
Hospital Universitari Mutua Terrassa Recruiting
Terrassa, Barcelona, Spain, 08221
Contact: Verónica Perea, MD    0034937365050 ext 11330    vperea@mutuaterrassa.cat   
Sponsors and Collaborators
Hospital Mutua de Terrassa
Investigators
Principal Investigator: Verónica Perea, MD Hospital Universitari Mutua Terrassa
  Study Documents (Full-Text)

Documents provided by Hospital Mutua de Terrassa:

Publications:
Responsible Party: Hospital Mutua de Terrassa
ClinicalTrials.gov Identifier: NCT03421262     History of Changes
Other Study ID Numbers: 00003
First Posted: February 5, 2018    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications