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Completed

NCT Number: NCT03372824

Glycated Albumin 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.

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Key information

Conditions

Gestational Diabetes 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

Age range

25 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Stavanger University hospital

Stavanger, Rogaland, 4068, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • primiparas >25 years old
  • singleton pregnancy

Exclusion criteria

  • prior diagnosed with diabetes

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Oral glucose tolerance test in pregnancy

    Time frame: Gestational week 24-28

    The oral glucose tolerance test (OGTT) will be performed according to national guidelines as a screening test for gestational diabetes

  2. HbA1c

    Time frame: Gestational week 24-28

    HbA1c, long-term bloodsugar, will be analyzed in blood sample taken during the OGTT for all participants

  3. Iron status

    Time frame: Gestational week 24-28

    Iron status might effect the HbA1c Level. We will analyse iron status in blood samples collected at the OGTT for all participants.

  4. Glycaemic control

    Time frame: Gestational week 24-37

    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

  5. Preeclampsia

    Time frame: From gestational week 20 until 1 week postpartum

    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

  6. Induction of labour

    Time frame: At delivery

    Register pregnancy outcome. Induction of Labour and indication for induction will be registered.

  7. 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.

  8. Birth weight

    Time frame: At delivery

    Register pregnancy outcome. Birth weight (gram) of the newborn will be registered

  9. 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

Official study title

Oral Glucose Tolerance Test (OGTT), HbA1c or Glycated Albumin - Can we Reduce the Need for OGTT in Pregnancy?

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 14, 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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