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NCT Number: NCT03330951

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

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).

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Key information

Conditions

Diabetes Mellitus Pregnancy Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Stavanger University Hospital

Stavanger, Rogaland, 4068, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • gestational diabetes
  • twin pregnancies

Treatment and study plan

Primary outcomes

  1. Glycemic Control markers in pregnancy

    Time frame: throughout pregnancy, gestational week 12-36.

    Compare HbA1c and glycated albumin to blood sugar measurements

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Helse Stavanger HF

Other Gov

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Nov 6, 2017
Registry last updated
Jan 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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