Glycemic Control and Iron Status in Diabetic Pregnancies - a Study of New Markers

NCT03330951 | Completed

• 1 other identifier: SUS-ID580
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

This is an observational study at the Obstetrical outpatient clinic at Stavanger University Hospital. The main goal is to compare the current marker of glycemic control (glycated hemoglobin A1c, HbA1c) with glycated albumin in pregnancies with pregestational diabetes mellitus. Women with diabetes are at increased risk for adverse pregnancy outcomes. With improved glycemic control, the risk decreases. Glycated albumin is suggested to be a better marker for monitoring glycemic control in pregnancies because it reflects blood glucose for a shorter period than HbA1c (3 versus 8-12 weeks). Other studies have shown that HbA1c increases in pregnancy because of iron deficiency. The investigators want to investigate HbA1c, glycated albumin and iron status in diabetic pregnancies. The investigators will compare HbA1c and glycated albumin throughout pregnancy with the patient's own blood glucose measurements or data from CGM (continuous blood glucose monitoring). Blood samples for HbA1c and glycated albumin will be taken 6 times during pregnancy (week 12, 20, 24, 28, 32, 36).

Conditions

Diabetes Mellitus Pregnancy

Keywords

HbA1c; Glycated albumin

Outcome Measures

Primary Outcomes (1)

• Glycemic Control markers in pregnancy

  Compare HbA1c and glycated albumin to blood sugar measurements

  throughout pregnancy, gestational week 12-36.

Secondary Outcomes (7)

• Iron status in diabetic pregnancy,

  throughout pregnancy, gestational week 12-36.

• Preterm delivery

  at delivery.

• Preeclampsia

  From gestational week 20 to 1 week after delivery.

• Induction of labour

  At delivery.

• APGAR

  At delivery.

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Pregnant women with pregestational diabetes mellitus

You may qualify if:

• pregestational diabetes mellitus
• singleton pregnancy
• follow-up at Stavanger University Hospital in pregnancy

You may not qualify if:

• gestational diabetes
• twin pregnancies

Sponsors & Collaborators

• Helse Stavanger HF: lead

Study Sites (1)

Stavanger University Hospital

Stavanger, Rogaland, 4068, Norway

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood and urine samples

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Johanne Toft, MD

  Helse Stavanger HF

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2016
• First Posted: November 6, 2017
• Study Start: May 1, 2016
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: January 27, 2020

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)