Gestational DiabetesNCT03372824
Glycated Albumin in Pregnancy
An observational study of Gestational Diabetes, run by Helse Stavanger HF at 1 site in Norway.
Trial summary
This is an observational study at the Obstetrical outpatient clinic at Stavanger University Hospital, Norway. The purpose of the study is to compare glycated albumin and glycated hemoglobin (HbA1c), both markers of "long-term blood sugar" with oral glucose tolerance test (OGTT). Read more about this study
- Who is it for?
- Ages 25 years and older, women only
- Conditions the study is for
- Gestational Diabetes
- How many people
- 148 participants
- Where
- 1 siteNorway
- Study dates
- 1 Nov 2017to 1 Feb 2019
- 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 25 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Primiparas above the age of 25 years old at conception. Women will be asked to participate in the study when they atttend an ultrasound examination at the Obstetrical outpatient clinic, Stavanger University Hospital, in gestational week 18-20.
Who may be able to join
- primiparas >25 years old
- singleton pregnancy
Who cannot join
- prior diagnosed with diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Glucose Tolerance Test (OGTT), HbA1c or Glycated Albumin - Can we Reduce the Need for OGTT in Pregnancy?
This is an observational study at the Obstetrical outpatient clinic at Stavanger University Hospital, Norway. The purpose of the study is to compare glycated albumin and glycated hemoglobin (HbA1c), both markers of "long-term blood sugar" with oral glucose tolerance test (OGTT). The OGTT is a screening test for gestational diabetes, a condition that increases risk of adverse pregnancy outcome for mother and child. The risks are reduced with good glycaemic control throughout pregnancy, therefore, it is important to screen for gestational diabetes.
Read the detailed description
According to the new guideline by the Norwegian Directorate of Health published april 2017, screening for gestational diabetes is increased. All pregnant women with a slight risk, approximately 70 % of pregnant women i Norway, should have an OGTT performed in gestational week 24-28. Among those women, all primiparas above the age of 25 years old.
The investigators will include 150 primiparas above the age of 25 years old in the study. The women will be asked to participate in the study when they attend an ultrasound examination at the Obstetric outpatient clinic in gestational week 18-20. Prior to inclusion, participants need to sign written informed consent.
Included women will get an appointment for OGTT in gestational week 24-28 at the Clinical trial unit, Stavanger University hospital. The OGTT will be performed according to national guidelines. The participants will fill in a single questionaire with information on age, height, ethnicity, whether there is diabetes in close family, any other illnesses, smoking habits and other medications/supplements.
In addition, to blood sugar levels, markers of importance for glycaemic control, iron status and vitamin-D status will be analyzed.
Women diagnosed with gestational diabetes or overt diabetes mellitus, will be followed up according to national guidelines.
- Conditions
- Gestational Diabetes
- Keywords
- mass screening
- 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 |
|---|---|---|
| Pregnant women | Primiparas above 25 years of age, singleton pregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycated albumin reference interval in pregnancy
Glycated albumin will be analyzed by a new method based on mass spectrometry. Glycated albumin will be analyzed in blood samples taken during the OGTT.
Measured: gestational week 24-28
Secondary outcomes (9)
Oral glucose tolerance test in pregnancy
The oral glucose tolerance test (OGTT) will be performed according to national guidelines as a screening test for gestational diabetes
Measured: Gestational week 24-28
HbA1c
HbA1c, long-term bloodsugar, will be analyzed in blood sample taken during the OGTT for all participants
Measured: Gestational week 24-28
Iron status
Iron status might effect the HbA1c Level. We will analyse iron status in blood samples collected at the OGTT for all participants.
Measured: Gestational week 24-28
Glycaemic control
For women diagnosed with gestational diabetes, we will register blood sugar measurements from diagnosis until gestational week 37. These measurements will be compared to HbA1c and glycated albumin levels in blood sample taken in gestational week 37
Measured: Gestational week 24-37
Preeclampsia
Pregnancy outcome. New onset systolic blood pressure >140, diastolic blood pressure >90 after gestational week 20 and proteinuria 2+ according to urine dipstick, will be registered as preeclampsia
Measured: From gestational week 20 until 1 week postpartum
Induction of labour
Register pregnancy outcome. Induction of Labour and indication for induction will be registered.
Measured: At delivery
APGAR
Register pregnancy outcome. APGAR score (Appearance, Pulse, Grimace, Activity, Respiration) of the newborn will be registered for 1 minute, 5 minute and 10 minutes after delivery.
Measured: At delivery
Birth weight
Register pregnancy outcome. Birth weight (gram) of the newborn will be registered
Measured: At delivery
Admission to neonatal intensive care unit
Register pregnancy outcome. Admission to neonatal intensive care unit will be registered.
Measured: At delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2017
- Study start1 Nov 2017
- Primary completion1 Feb 2019
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- 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
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Stavanger HF
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Johanne H Toft, MD, Principal investigator, Helse Stavanger HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03372824
- Sponsor's protocol ID
- SUS-ID651
- Status last verified
- Dec 2017
- First submitted
- 4 Dec 2017
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Glucose Tolerance Test (OGTT), HbA1c or Glycated Albumin - Can we Reduce the Need for OGTT in Pregnancy?
- ClinicalTrials.gov ID
- NCT03372824
- Acronym / sponsor ID
- SUS-ID651
- Conditions
- Gestational Diabetes
- Keywords
- mass screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Helse Stavanger HFOther government
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 14 Dec 2017 (actual)
- 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.
This is an observational study at the Obstetrical outpatient clinic at Stavanger University Hospital, Norway. The purpose of the study is to compare glycated albumin and glycated hemoglobin (HbA1c), both markers of "long-term blood sugar" with oral glucose tolerance test (OGTT). The OGTT is a screening test for gestational diabetes, a condition that increases risk of adverse pregnancy outcome for mother and child. The risks are reduced with good glycaemic control throughout pregnancy, therefore, it is important to screen for gestational diabetes.
Detailed description
According to the new guideline by the Norwegian Directorate of Health published april 2017, screening for gestational diabetes is increased. All pregnant women with a slight risk, approximately 70 % of pregnant women i Norway, should have an OGTT performed in gestational week 24-28. Among those women, all primiparas above the age of 25 years old.
The investigators will include 150 primiparas above the age of 25 years old in the study. The women will be asked to participate in the study when they attend an ultrasound examination at the Obstetric outpatient clinic in gestational week 18-20. Prior to inclusion, participants need to sign written informed consent.
Included women will get an appointment for OGTT in gestational week 24-28 at the Clinical trial unit, Stavanger University hospital. The OGTT will be performed according to national guidelines. The participants will fill in a single questionaire with information on age, height, ethnicity, whether there is diabetes in close family, any other illnesses, smoking habits and other medications/supplements.
In addition, to blood sugar levels, markers of importance for glycaemic control, iron status and vitamin-D status will be analyzed.
Women diagnosed with gestational diabetes or overt diabetes mellitus, will be followed up according to national guidelines.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women | – | –Primiparas above 25 years of age, singleton pregnancy |
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primiparas above the age of 25 years old at conception. Women will be asked to participate in the study when they atttend an ultrasound examination at the Obstetrical outpatient clinic, Stavanger University Hospital, in gestational week 18-20.
Key inclusion criteria (2 listed)
- primiparas >25 years old
- singleton pregnancy
Key exclusion criteria (1 listed)
- prior diagnosed with 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
Glycated albumin reference interval in pregnancy
Time frame: gestational week 24-28
Glycated albumin will be analyzed by a new method based on mass spectrometry. Glycated albumin will be analyzed in blood samples taken during the OGTT.
9 secondary outcomes
Oral glucose tolerance test in pregnancy
Time frame: Gestational week 24-28
HbA1c
Time frame: Gestational week 24-28
Iron status
Time frame: Gestational week 24-28
Glycaemic control
Time frame: Gestational week 24-37
Preeclampsia
Time frame: From gestational week 20 until 1 week postpartum
Induction of labour
Time frame: At delivery
APGAR
Time frame: At delivery
Birth weight
Time frame: At delivery
Admission to neonatal intensive care unit
Time frame: At delivery
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 27 Jan 2020.
- Individual participant dataSharing planned: No
Related trials for Gestational Diabetes
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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.
Johanne H Toft, MD principal investigator
Helse Stavanger HF
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 Helse Stavanger HF at 1 site in Norway.
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 2 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 27 Jan 2020. 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 Norway. 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?
Glycated albumin reference interval in pregnancy (time frame: gestational week 24-28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jan 2020.