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

Diabetes Mellitus Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03330951
• Other study ID #: SUS-ID580
• Status: Completed
• Start date: May 2016
• Est. completion date: February 2019

Study information

• Verified date: December 2018
• Source: Helse Stavanger HF
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: February 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• pregestational diabetes mellitus

• singleton pregnancy

• follow-up at Stavanger University Hospital in pregnancy

Exclusion Criteria:

• gestational diabetes

• twin pregnancies

Related Conditions & MeSH terms

• Diabetes Mellitus Pregnancy
• Pregnancy in Diabetics

Locations

Country	Name	City	State
Norway	Stavanger University Hospital	Stavanger	Rogaland

Sponsors (1)

Lead Sponsor	Collaborator
Helse Stavanger HF

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic Control markers in pregnancy	Compare HbA1c and glycated albumin to blood sugar measurements	throughout pregnancy, gestational week 12-36.
Secondary	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.
Secondary	Preterm delivery	Register pregnancy outcomes. Delivery before gestational week 37 will be registered. Data will be collected from journals.	at delivery.
Secondary	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.
Secondary	Induction of labour	Register pregnancy outcome. Induction of Labour and indication for induction will be registered.	At delivery.
Secondary	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.
Secondary	Birth weight	Register pregnancy outcome. Birth weight (gram) of the newborn will be registered.	At delivery.
Secondary	Admission to neonatal intensive care unit	Register pregnancy outcome. Admission to neonatal intensive care unit will be registered.	At delivery.