Glycated Albumin in Pregnancy

Completed

• Conditions: Gestational Diabetes

• Registration Number: NCT03372824
• Lead Sponsor: Helse Stavanger HF

Brief Summary

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.

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 Timeline

• Study Start: 2017-11-01
• Status Verified: 2017-12
• Study First Submitted: 2017-12-04
• Study First Submitted QC: 2017-12-08
• Study First Posted: 2017-12-14
• Primary Completion: 2019-02-01
• Study Completion: 2019-02-01
• Last Update Submitted: 2020-01-24
• Last Update Posted: 2020-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 148

Inclusion Criteria

• primiparas >25 years old
• singleton pregnancy

Exclusion criteria:

• prior diagnosed with diabetes

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Glycated albumin reference interval in pregnancy	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 Outcome Measures

Name	Time	Method
Induction of labour	At delivery	Register pregnancy outcome. Induction of Labour and indication for induction will be registered.
Preeclampsia	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
Birth weight	At delivery	Register pregnancy outcome. Birth weight (gram) of the newborn will be registered
Oral glucose tolerance test in pregnancy	Gestational week 24-28	The oral glucose tolerance test (OGTT) will be performed according to national guidelines as a screening test for gestational diabetes
HbA1c	Gestational week 24-28	HbA1c, long-term bloodsugar, will be analyzed in blood sample taken during the OGTT for all participants
Iron status	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.
Glycaemic control	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
APGAR	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.
Admission to neonatal intensive care unit	At delivery	Register pregnancy outcome. Admission to neonatal intensive care unit will be registered.

Trial Locations

Locations (1)

Stavanger University hospital; 🇳🇴 Stavanger, Rogaland, Norway