Glycemic Control and Iron Status in Diabetic Pregnancies - a Study of New Markers

NCT ID: NCT03330951

Last Updated: 2020-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

41 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-31

Study Completion Date

2019-02-28

Brief Summary

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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).

Detailed Description

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Conditions

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Diabetes Mellitus Pregnancy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* pregestational diabetes mellitus
* singleton pregnancy
* follow-up at Stavanger University Hospital in pregnancy

Exclusion Criteria

* gestational diabetes
* twin pregnancies
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Helse Stavanger HF

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Johanne Toft, MD

Role: PRINCIPAL_INVESTIGATOR

Helse Stavanger HF

Locations

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Stavanger University Hospital

Stavanger, Rogaland, Norway

Site Status

Countries

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Norway

Other Identifiers

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SUS-ID580

Identifier Type: -

Identifier Source: org_study_id

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