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Gestational DiabetesGDM HbA1cNCT02139254

First Trimester Glycosylated Haemoglobin Und Plasma Glucose in Women at High Risk for Gestational Diabetes

An observational study of Gestational Diabetes, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Gestational diabetes mellitus (GDM) is defined as carbohydrate intolerance with onset or first recognition during pregnancy. If insulin resistance and hyperglycemia are recognized before pregnancy, the term pregestational diabetes (PGD) is used. Read more about this study

Who is it for?
Any age, women onlyHealthy volunteers can take part
Conditions the study is for
Gestational Diabetes
How many people
1,800 participants
Where
1 siteSwitzerland
Study dates
Aug 2013to 20 Sep 2018
Phase
Observational
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 Any age
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: Pregnant women who receive antenatal care at the Department of Obstetrics in our Hospital and have the first vist between 8. and 12. week of pregnancy. Women with pregestational diabetes are excluded.

Who may be able to join

  • Pregnancy
  • 8-13 weeks of gestation
  • Written informed consent

Who cannot join

  • Pregestational diabetes

Trial locations and contacts

1 site in 1 country.

Switzerland1 site
  • Dep. of Obstetrics and Gynecology

    Bern, 3010

Other trials in Switzerland

About this study

Gestational diabetes mellitus (GDM) is defined as carbohydrate intolerance with onset or first recognition during pregnancy. If insulin resistance and hyperglycemia are recognized before pregnancy, the term pregestational diabetes (PGD) is used. In the last years, much has been invested to uniformly define worldwide the diagnostic criteria and the management of gestational diabetes. A general screening in a low risk population should be implemented into routine prenatal care. Similarly, pregnant women at high risk for metabolic disorders should be screened in the early pregnancy.

The aim of the following study ist to investigate the role of first trimester glycosylated haemoglobin (HbA1c) of pregnant women with risk factors in developing gestational diabetes mellitus (GDM).

Read the detailed description

Background

Gestational diabetes mellitus (GDM) is defined as carbohydrate intolerance with onset or first recognition during pregnancy. If insulin resistance and hyperglycemia are recognized before pregnancy, the term pregestational diabetes (PGD) is used. In the last years, much has been invested to uniformly define worldwide the diagnostic criteria and the management of gestational diabetes. Recently, the American Diabetes Association stated that a general screening in a low risk population should be implemented into routine prenatal care. However, there are still controversies on which diagnostic criteria to use. Similarly, screening of pregnant women at high risk for PGD is also a matter of debate. This is an important issue as the prevalence of this group is increasing worldwide. Of interest, the ADA as well as the international expert committee on diabetes published a consensus statement in which the use of HbA1c was supported for the diagnosis of diabetes rather than the measurement of fasting or post-prandial plasma glucose in a non-pregnant population. A value of ≥6.5% (≥48mmol/mol) was proposed as criterion for diagnosis. There is no doubt that the measurement of glycosylated haemoglobin may be of value in particular preconceptional in diabetes type 1. Difference exist in using HbA1c during pregnancy. At the pregnant state, the different red cell turnover and other physiologic changes in pregnancy may interfere with HbA1c. Indeed, mean HBA1c levels in healthy pregnant women are lower than in the non-pregnant women. Moreover, O'Connor et al. showed that first and second trimester HbA1c values are significantly different to a non-pregnant population, whereas no difference was found comparing HbA1c values from the third trimester. Therefore, it has been suggested, that only blood glucose criteria should be used to diagnose or exclude PGD in particular during the first trimester as the data on HBA1c in the first trimester is limited .

Objective

To observe the values of HbA1c obtained from pregnant women in the early pregnancy, the difference between those who develop GDM and those who do not and the comparison of first trimester HBA1c, Plasma Glucose and angiogenesis factors.

Methods

This is an observational prospective cohort study conducted in our Department of Obstetrics. All women are tested for HbA1c at the first antenatal visit during the first trimester. First trimester was defined as up to 12 6/7 weeks of gestation. Between 24 and 28 weeks of gestation the women are screened, as internationally proposed, by a "one-step" standardized 75g oral glucose tolerance test (oGTT). Venous blood samples were collected at 0, 1, and 2h after the glucose load. Women with pre-existing diabetes mellitus or a first trimester HbA1c ≥6.5% are excluded from the study und medical care for pregestational diabetes is provided.

Keywords
Gestational Diabetes, HbA1c, Glucose, First Trimenon
Medical subject headings
Diabetes, Gestational

What participants receive

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

Study groups in NCT02139254
Study groupRoleWhat they receive
Low riskPregnant women with a low risk for metabolic diseases
High riskPregnant women with a high risk for metabolic diseases

What is being measured

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

  1. Number of women with gestational diabetes

    Measured: Week 28 of pregnancy

Secondary outcomes (1)
  1. Delivery Mode

    Measured: At delivery, expected to be on average after 40 weeks

Timeline

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

  1. First posted15 May 2014 (estimated)
  2. Study startAug 2013
  3. Primary completion29 Sep 2017
  4. Study completion20 Sep 2018

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,800 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02139254
Sponsor's protocol ID
030/13
Acronym
GDM HbA1c
Status last verified
Oct 2018
First submitted
13 May 2014
Last updated
3 Oct 2018
Results posted
No
Data monitoring committee
No

Publications

  • Amylidi-Mohr S, Lang C, Mosimann B, Fiedler GM, Stettler C, Surbek D, Raio L. First-trimester glycosylated hemoglobin (HbA1c) and maternal characteristics in the prediction of gestational diabetes: An observational cohort study. Acta Obstet Gynecol Scand. 2023 Mar;102(3):294-300. doi: 10.1111/aogs.14495. Epub 2022 Dec 16.

    PubMed 36524557

Questions about this trial

What is this clinical trial studying?

An observational study of Gestational Diabetes, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

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 1 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: finished, as of the sponsor's last update on 3 Oct 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 Switzerland. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of women with gestational diabetes (time frame: Week 28 of pregnancy). 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 NCT02139254, 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 3 Oct 2018.

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GDM HbA1c Clinical Trial NCT02139254 | AzTrials