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

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ClinicalTrials.gov Identifier: NCT03330951
Recruitment Status : Completed
First Posted : November 6, 2017
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Helse Stavanger HF

Brief 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.

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).


Condition or disease
Diabetes Mellitus Pregnancy

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Study Type : Observational
Actual Enrollment : 41 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Glycemic Control and Iron Status in Diabetic Pregnancies - a Study of New Markers
Actual Study Start Date : May 2016
Actual Primary Completion Date : February 2019
Actual Study Completion Date : February 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Glycemic Control markers in pregnancy [ Time Frame: throughout pregnancy, gestational week 12-36. ]
    Compare HbA1c and glycated albumin to blood sugar measurements


Secondary Outcome Measures :
  1. Iron status in diabetic pregnancy, [ Time Frame: throughout pregnancy, gestational week 12-36. ]
    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.

  2. Preterm delivery [ Time Frame: at delivery. ]
    Register pregnancy outcomes. Delivery before gestational week 37 will be registered. Data will be collected from journals.

  3. Preeclampsia [ Time Frame: From gestational week 20 to 1 week after delivery. ]
    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

  4. Induction of labour [ Time Frame: At delivery. ]
    Register pregnancy outcome. Induction of Labour and indication for induction will be registered.

  5. APGAR [ Time Frame: At delivery. ]
    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.

  6. Birth weight [ Time Frame: At delivery. ]
    Register pregnancy outcome. Birth weight (gram) of the newborn will be registered.

  7. Admission to neonatal intensive care unit [ Time Frame: At delivery. ]
    Register pregnancy outcome. Admission to neonatal intensive care unit will be registered.


Biospecimen Retention:   Samples With DNA
Blood and urine samples


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Pregnant women with pregestational diabetes mellitus
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • gestational diabetes
  • twin pregnancies

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03330951


Locations
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Norway
Stavanger University Hospital
Stavanger, Rogaland, Norway, 4068
Sponsors and Collaborators
Helse Stavanger HF
Investigators
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Principal Investigator: Johanne Toft, MD Helse Stavanger HF
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Responsible Party: Helse Stavanger HF
ClinicalTrials.gov Identifier: NCT03330951    
Other Study ID Numbers: SUS-ID580
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Helse Stavanger HF:
HbA1c
Glycated albumin
Additional relevant MeSH terms:
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Pregnancy in Diabetics
Pregnancy Complications