Diabetes Mellitus PregnancyNCT03330951
Glycemic Control and Iron Status in Diabetic Pregnancies - a Study of New Markers
An observational study of Diabetes Mellitus Pregnancy, 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. The main goal is to compare the current marker of glycemic control (glycated hemoglobin A1c, HbA1c) with glycated albumin in pregnancies with pregestational diabetes mellitus. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Diabetes Mellitus Pregnancy
- How many people
- 41 participants
- Where
- 1 siteNorway
- Study dates
- May 2016to 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pregnant women with pregestational diabetes mellitus
Who may be able to join
- pregestational diabetes mellitus
- singleton pregnancy
- follow-up at Stavanger University Hospital in pregnancy
Who cannot join
- gestational diabetes
- twin pregnancies
Trial locations and contacts
1 site in 1 country.
About this study
This is an observational study at the Obstetrical outpatient clinic at Stavanger University Hospital. The main goal is to compare the current marker of glycemic control (glycated hemoglobin A1c, HbA1c) with glycated albumin in pregnancies with pregestational diabetes mellitus.
Women with diabetes are at increased risk for adverse pregnancy outcomes. With improved glycemic control, the risk decreases. Glycated albumin is suggested to be a better marker for monitoring glycemic control in pregnancies because it reflects blood glucose for a shorter period than HbA1c (3 versus 8-12 weeks). Other studies have shown that HbA1c increases in pregnancy because of iron deficiency. The investigators want to investigate HbA1c, glycated albumin and iron status in diabetic pregnancies. The investigators will compare HbA1c and glycated albumin throughout pregnancy with the patient's own blood glucose measurements or data from CGM (continuous blood glucose monitoring). Blood samples for HbA1c and glycated albumin will be taken 6 times during pregnancy (week 12, 20, 24, 28, 32, 36).
- Conditions
- Diabetes Mellitus Pregnancy
- Keywords
- HbA1c, Glycated albumin
- Medical subject headings
- Diabetes, Gestational
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic Control markers in pregnancy
Compare HbA1c and glycated albumin to blood sugar measurements
Measured: throughout pregnancy, gestational week 12-36.
Secondary outcomes (7)
Iron status in diabetic pregnancy,
Compare current markers of iron status with hepcidin throghout diabetic pregnancies by analyses of blood samples in gestational week 12, 20, 24, 28, 32 and 36.
Measured: throughout pregnancy, gestational week 12-36.
Preterm delivery
Register pregnancy outcomes. Delivery before gestational week 37 will be registered. Data will be collected from journals.
Measured: at delivery.
Preeclampsia
Register pregnancy outcomes. 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 to 1 week after delivery.
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 posted6 Nov 2017
- Study startMay 2016
- Primary completionFeb 2019
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus PregnancyStudies 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
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Stavanger HF
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Johanne Toft, MD, Principal investigator, Helse Stavanger HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03330951
- Sponsor's protocol ID
- SUS-ID580
- Status last verified
- Dec 2018
- First submitted
- 17 Nov 2016
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- 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
- Glycemic Control and Iron Status in Diabetic Pregnancies - a Study of New Markers
- ClinicalTrials.gov ID
- NCT03330951
- Acronym / sponsor ID
- SUS-ID580
- Conditions
- Diabetes Mellitus Pregnancy
- Keywords
- HbA1c, Glycated albumin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Helse Stavanger HFOther government
- Study start
- May 2016 (actual)
- Primary completion
- Feb 2019 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 6 Nov 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. The main goal is to compare the current marker of glycemic control (glycated hemoglobin A1c, HbA1c) with glycated albumin in pregnancies with pregestational diabetes mellitus.
Women with diabetes are at increased risk for adverse pregnancy outcomes. With improved glycemic control, the risk decreases. Glycated albumin is suggested to be a better marker for monitoring glycemic control in pregnancies because it reflects blood glucose for a shorter period than HbA1c (3 versus 8-12 weeks). Other studies have shown that HbA1c increases in pregnancy because of iron deficiency. The investigators want to investigate HbA1c, glycated albumin and iron status in diabetic pregnancies. The investigators will compare HbA1c and glycated albumin throughout pregnancy with the patient's own blood glucose measurements or data from CGM (continuous blood glucose monitoring). Blood samples for HbA1c and glycated albumin will be taken 6 times during pregnancy (week 12, 20, 24, 28, 32, 36).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant women with pregestational diabetes mellitus
Key inclusion criteria (3 listed)
- pregestational diabetes mellitus
- singleton pregnancy
- follow-up at Stavanger University Hospital in pregnancy
Key exclusion criteria (2 listed)
- gestational diabetes
- twin pregnancies
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
Glycemic Control markers in pregnancy
Time frame: throughout pregnancy, gestational week 12-36.
Compare HbA1c and glycated albumin to blood sugar measurements
7 secondary outcomes
Iron status in diabetic pregnancy,
Time frame: throughout pregnancy, gestational week 12-36.
Preterm delivery
Time frame: at delivery.
Preeclampsia
Time frame: From gestational week 20 to 1 week after delivery.
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
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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 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 Diabetes Mellitus Pregnancy, 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 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: 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?
Glycemic Control markers in pregnancy (time frame: throughout pregnancy, gestational week 12-36.). 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.