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

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).

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus Pregnancy

• Study Type: Observational
• Enrollment (Actual): 41

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Pregnant women with pregestational diabetes mellitus

Description

Inclusion Criteria:

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

Exclusion Criteria:

• gestational diabetes
• twin pregnancies

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic Control markers in pregnancy	Compare HbA1c and glycated albumin to blood sugar measurements	throughout pregnancy, gestational week 12-36.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Iron status in diabetic pregnancy,	Compare current markers of iron status with hepcidin throghout diabetic pregnancies by analyses of blood samples in gestational week 12, 20, 24, 28, 32 and 36.	throughout pregnancy, gestational week 12-36.
Preterm delivery	Register pregnancy outcomes. Delivery before gestational week 37 will be registered. Data will be collected from journals.	at delivery.
Preeclampsia	Register pregnancy outcomes. 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 to 1 week after delivery.
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 Toft, MD, Helse Stavanger HF

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): February 1, 2019
• Study Completion (Actual): February 1, 2019

Study Registration Dates

• First Submitted: November 17, 2016
• First Submitted That Met QC Criteria: November 2, 2017
• First Posted (Actual): November 6, 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, 2018

More Information

Terms related to this study

• Keywords: HbA1c; Glycated albumin
• Additional Relevant MeSH Terms: Pregnancy Complications; Pregnancy in Diabetics
• Other Study ID Numbers: SUS-ID580

Plan for Individual participant data (IPD)

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