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AzTrials

Gestational DiabetesPOMECNCT03421262

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

A study testing IADPSG Criteria and NDDG Criteria in people with Gestational Diabetes, run by Hospital Mutua de Terrassa at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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). Read more about this study

Who is it for?
Ages 18 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for
Gestational Diabetes
What is being tested?
IADPSG Criteria and NDDG Criteria
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,644 participants
Where
1 siteSpain
Study dates
1 Jun 2017to Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Verónica Perea, MD contact

0034937365050 ext. 11330

vperea@mututaterrassa.cat

Spain1 site, 1 recruiting

  • Hospital Universitari Mutua Terrassa

    Terrassa, Barcelona, 08221

    Verónica Perea, MD, 0034937365050 ext. 11330, vperea@mutuaterrassa.cat

    Recruiting

Other trials in Spain

About this study

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

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).

Read the 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.

Being tested
IADPSG Criteria, NDDG Criteria
Medical subject headings
Diabetes, Gestational

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IADPSG CriteriaDiagnostic test

    One-step: 2 hr 75 gr OGTT

  • NDDG CriteriaDiagnostic test

    Osullivan test + 3 h 100 g OGTT

Study groups in NCT03421262
Study groupRoleWhat they receive
One-step:IADPSG CriteriaExperimentalGestational 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.
Receives: Diagnostic Test: IADPSG Criteria
Two-step:NDDG CriteriaActive comparatorStep 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
Receives: Diagnostic Test: NDDG Criteria

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Large for gestational age

    Infant birthweight >90th centile using customized growth curves

    Measured: At birth of infant

Secondary outcomes (22)

  1. Macrosomia

    infant birthweight >=4kg

    Measured: At birth of infant

  2. Small for gestational age

    infant birthweight <10th centile using customized growth curves

    Measured: At birth of infant

  3. Hypertension in pregnant

    classification according to American College of Obstetricians and Gynecologists (Task Force on Hypertension in Pregnancy).

    Measured: First 3 months postpartum

  4. Neonatal obstetric trauma

    rate of shoulder dystocia, clavicle fracture, brachial plexus injury and intrapartum asphyxia

    Measured: At birth of infant

  5. Congenital anomalies

    Coding of EUROCAT

    Measured: At birth of infant

  6. Neonatal hypoglycemia

    neonatal plasma glucose levels of <2.5 mmol/L in the first 24 hours of life and <2.8 mmol/L thereafter.

    Measured: up to 4 weeks after delivery

  7. Neonatal hypocalcemia

    neonatal calcium levels of <7mg/dl

    Measured: up to 4 weeks after delivery

  8. Neonatal hyperbilirubinemia

    hyperbilirubinemia treated with phototherapy

    Measured: up to 4 weeks after delivery

  9. Neonatal polycythemia

    hematocrit from a peripheral venous sample is >65 percent

    Measured: up to 4 weeks after delivery

  10. Respiratory Distress Syndrome

    onset of progressive respiratory failure shortly after birth, in conjunction with a characteristic chest radiograph (after ruling out other causes).

    Measured: up to 4 weeks after delivery

  11. Infant Outcomes

    Pregnancy loss (Miscarriage, stillbirth, neonatal death)

    Measured: up to 4 weeks after delivery

  12. Hypertrophic cardiomyopathy

    increased left ventricular (LV) wall thickness ≥15 mm is imaged anywhere in the LV wall (by transthoracic echocardiography)

    Measured: up to 4 weeks after delivery

  13. Polyhydramnios

    Amniotic fluid index ≥25 cm

    Measured: At birth of infant

  14. Gestational age at delivery

    Gestational age was defined as completed weeks based on last menstrual period or the earliest ultrasound assessment if discordant.

    Measured: At birth of infant

  15. Cesarean section

    delivery of a baby through a surgical incision in the mother's abdomen and uterus

    Measured: At birth of infant

  16. 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.

    Measured: First 7days postpartum

  17. NICU admission

    NICU admission for treatment or surveillance

    Measured: up to 4 weeks after delivery

  18. Maternal hospital stay

    Length of hospital stay (days)

    Measured: up to 4 weeks from maternal discharge

  19. Neonatal hospital stay

    Length of hospital stay (days)

    Measured: up to 4 weeks from neonatal discharge

  20. Evaluation of mediterranean diet adherence

    using Mediterranean Diet Adherence Screener (MEDAS) questionnaire. Score betwwen 0-14; high score indicate maximum mediterranean diet adherence.

    Measured: up to 12-14weeks from last menstrual period.

  21. 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)

    Measured: up to 12-14weeks from last menstrual period.

  22. 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 (€).

    Measured: First 3 months postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2018
  2. Study start1 Jun 2017
  3. Primary completion27 Nov 2018 (estimated)
  4. Study completionDec 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
3,644 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03421262
Sponsor's protocol ID
00003
Acronym
POMEC
Status last verified
Jan 2018
First submitted
27 Nov 2017
Last updated
5 Feb 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 18463375

Questions about this trial

What is this clinical trial studying?

A study testing IADPSG Criteria and NDDG Criteria in people with Gestational Diabetes, run by Hospital Mutua de Terrassa at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Verónica Perea, MD (0034937365050 ext. 11330, vperea@mututaterrassa.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Large for gestational age (time frame: At birth of infant). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03421262, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2018.

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