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

Completed

• Conditions: Diabetes Mellitus Pregnancy

• Registration Number: NCT03330951
• Lead Sponsor: Helse Stavanger HF

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-11-17
• Study First Submitted QC: 2017-11-02
• Study First Posted: 2017-11-06
• Status Verified: 2018-12
• Primary Completion: 2019-02
• Study Completion: 2019-02
• Last Update Submitted: 2020-01-24
• Last Update Posted: 2020-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 41

Inclusion Criteria

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

Exclusion Criteria

• gestational diabetes
• twin pregnancies

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Glycemic Control markers in pregnancy	throughout pregnancy, gestational week 12-36.	Compare HbA1c and glycated albumin to blood sugar measurements

Secondary Outcome Measures

Name	Time	Method
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.
Iron status in diabetic pregnancy,	throughout pregnancy, gestational week 12-36.	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.
Preeclampsia	From gestational week 20 to 1 week after delivery.	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
Induction of labour	At delivery.	Register pregnancy outcome. Induction of Labour and indication for induction will be registered.
Birth weight	At delivery.	Register pregnancy outcome. Birth weight (gram) of the newborn will be registered.
Preterm delivery	at delivery.	Register pregnancy outcomes. Delivery before gestational week 37 will be registered. Data will be collected from journals.

Trial Locations

Locations (1)

Stavanger University Hospital; 🇳🇴 Stavanger, Rogaland, Norway