Glycated Albumin in Pregnancy

Sponsor

Helse Stavanger HF (Other)

Overall Status

Completed

CT.gov ID

NCT03372824

Collaborator

(none)

148

Enrollment

Location

Actual Duration (Months)

9.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational

Actual Enrollment :

148 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Nov 1, 2017

Actual Primary Completion Date :

Feb 1, 2019

Actual Study Completion Date :

Feb 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Pregnant women Primiparas above 25 years of age, singleton pregnancy

Outcome Measures

Primary Outcome Measures

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

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
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
Induction of labour [At delivery]
Register pregnancy outcome. Induction of Labour and indication for induction will be registered.
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.
Birth weight [At delivery]
Register pregnancy outcome. Birth weight (gram) of the newborn will be registered
Admission to neonatal intensive care unit [At delivery]
Register pregnancy outcome. Admission to neonatal intensive care unit will be registered.

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

primiparas >25 years old
singleton pregnancy

Exclusion criteria:

prior diagnosed with diabetes

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stavanger University hospital	Stavanger	Rogaland	Norway	4068

Sponsors and Collaborators

Helse Stavanger HF

Investigators

Principal Investigator: Johanne H Toft, MD, Helse Stavanger HF

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Helse Stavanger HF

ClinicalTrials.gov Identifier:

NCT03372824

Other Study ID Numbers:

SUS-ID651

First Posted:

Dec 14, 2017

Last Update Posted:

Jan 27, 2020

Last Verified:

Dec 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Helse Stavanger HF

mass screening

Additional relevant MeSH terms:

Diabetes, Gestational

Study Results

No Results Posted as of Jan 27, 2020