Glycated Albumin in Pregnancy

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

Study Overview

• Status: Completed
• Conditions: Gestational Diabetes

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 148

Contacts and Locations

Study Locations

• Norway
  • Rogaland
    • Stavanger, Rogaland, Norway, 4068
      • Stavanger University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Primiparas above the age of 25 years old at conception. Women will be asked to participate in the study when they atttend an ultrasound examination at the Obstetrical outpatient clinic, Stavanger University Hospital, in gestational week 18-20.

Description

Inclusion Criteria:

• primiparas >25 years old
• singleton pregnancy

Exclusion criteria:

- prior diagnosed with diabetes

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Pregnant women; Primiparas above 25 years of age, singleton pregnancy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycated albumin reference interval in pregnancy	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.	gestational week 24-28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral glucose tolerance test in pregnancy	The oral glucose tolerance test (OGTT) will be performed according to national guidelines as a screening test for gestational diabetes	Gestational week 24-28
HbA1c	HbA1c, long-term bloodsugar, will be analyzed in blood sample taken during the OGTT for all participants	Gestational week 24-28
Iron status	Iron status might effect the HbA1c Level. We will analyse iron status in blood samples collected at the OGTT for all participants.	Gestational week 24-28
Glycaemic control	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	Gestational week 24-37
Preeclampsia	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	From gestational week 20 until 1 week postpartum
Induction of labour	Register pregnancy outcome. Induction of Labour and indication for induction will be registered.	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.	At delivery
Birth weight	Register pregnancy outcome. Birth weight (gram) of the newborn will be registered	At delivery
Admission to neonatal intensive care unit	Register pregnancy outcome. Admission to neonatal intensive care unit will be registered.	At delivery

Collaborators and Investigators

• Sponsor: Helse Stavanger HF
• Investigators: Principal Investigator: Johanne H Toft, MD, Helse Stavanger HF

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Actual): February 1, 2019
• Study Completion (Actual): February 1, 2019

Study Registration Dates

• First Submitted: December 4, 2017
• First Submitted That Met QC Criteria: December 8, 2017
• First Posted (Actual): December 14, 2017

Study Record Updates

• Last Update Posted (Actual): January 27, 2020
• Last Update Submitted That Met QC Criteria: January 24, 2020
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: mass screening
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Pregnancy Complications; Diabetes, Gestational
• Other Study ID Numbers: SUS-ID651

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No