Clinical trial NCT03372824: Glycated Albumin in Pregnancy
Official title: Oral Glucose Tolerance Test (OGTT), HbA1c or Glycated Albumin - Can we Reduce the Need for OGTT in Pregnancy?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gestational Diabetes
Keywords: mass screening
Lead sponsor: Helse Stavanger HF
Sponsor class: OTHER_GOV
First posted: 2017-12-14
Enrollment: 148
Sex: FEMALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: Inclusion Criteria:

* primiparas \>25 years old
* singleton pregnancy

Exclusion criteria:

- prior diagnosed with diabetes

Primary outcomes:
measure: Glycated albumin reference interval in pregnancy
timeFrame: gestational week 24-28
Secondary outcomes:
measure: Oral glucose tolerance test in pregnancy
timeFrame: Gestational week 24-28
measure: HbA1c
timeFrame: Gestational week 24-28
measure: Iron status
timeFrame: Gestational week 24-28
measure: Glycaemic control
timeFrame: Gestational week 24-37
measure: Preeclampsia
timeFrame: From gestational week 20 until 1 week postpartum
measure: Induction of labour
timeFrame: At delivery
measure: APGAR
timeFrame: At delivery
measure: Birth weight
timeFrame: At delivery
measure: Admission to neonatal intensive care unit
timeFrame: At delivery
Other outcomes:
Locations:
city: Stavanger
country: Norway
facility: Stavanger University hospital
state: Rogaland
Study officials:
affiliation: Helse Stavanger HF
name: Johanne H Toft, MD
role: PRINCIPAL_INVESTIGATOR
References: