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.
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.
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.
- Conditions
- Gestational Diabetes
- 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 group | Role | What they receive |
|---|---|---|
| Low risk | Pregnant women with a low risk for metabolic diseases | |
| High risk | Pregnant 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.
Number of women with gestational diabetes
Measured: Week 28 of pregnancy
Secondary outcomes (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.
- First posted15 May 2014 (estimated)
- Study startAug 2013
- Primary completion29 Sep 2017
- Study completion20 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luigi Raio, PD, Principal investigator, Frauenklinik Inselspital Bern
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First Trimester Glycosylated Haemoglobin Und Plasma Glucose in Women at High Risk for Gestational Diabetes
- ClinicalTrials.gov ID
- NCT02139254
- Acronym / sponsor ID
- GDM HbA1c / 030/13
- Conditions
- Gestational Diabetes
- Keywords
- Gestational Diabetes, HbA1c, Glucose, First Trimenon
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,800 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Aug 2013 (actual)
- Primary completion
- 29 Sep 2017 (actual)
- Study completion
- 20 Sep 2018 (actual)
- First posted
- 15 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low risk | – | –Pregnant women with a low risk for metabolic diseases |
| High risk | – | –Pregnant women with a high risk for metabolic diseases |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (3 listed)
- Pregnancy
- 8-13 weeks of gestation
- Written informed consent
Key exclusion criteria (1 listed)
- Pregestational diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of women with gestational diabetes
Time frame: Week 28 of pregnancy
1 secondary outcome
Delivery Mode
Time frame: At delivery, expected to be on average after 40 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2018.
- Derived from this study: PubMed 36524557Amylidi-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luigi Raio, PD principal investigator
Frauenklinik Inselspital Bern
1 site in 1 country: see every site and its status.
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.