Viewing Study NCT02139254



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Study NCT ID: NCT02139254
Status: COMPLETED
Last Update Posted: 2018-10-03
First Post: 2014-05-13

Brief Title: First Trimester Glycosylated Haemoglobin Und Plasma Glucose in Women at High Risk for Gestational Diabetes
Sponsor: Insel Gruppe AG University Hospital Bern
Organization: Insel Gruppe AG University Hospital Bern

Study Overview

Official Title: First Trimester Glycosylated Haemoglobin Und Plasma Glucose in Women at High Risk for Gestational Diabetes
Status: COMPLETED
Status Verified Date: 2018-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: GDM HbA1c
Brief Summary: Gestational diabetes mellitus GDM is defined as carbohydrate intolerance with onset or first recognition during pregnancy If insulin resistance and hyperglycemia are recognized before pregnancy the term pregestational diabetes PGD is used In the last years much has been invested to uniformly define worldwide the diagnostic criteria and the management of gestational diabetes A general screening in a low risk population should be implemented into routine prenatal care Similarly pregnant women at high risk for metabolic disorders should be screened in the early pregnancy

The aim of the following study ist to investigate the role of first trimester glycosylated haemoglobin HbA1c of pregnant women with risk factors in developing gestational diabetes mellitus GDM
Detailed Description: Background

Gestational diabetes mellitus GDM is defined as carbohydrate intolerance with onset or first recognition during pregnancy If insulin resistance and hyperglycemia are recognized before pregnancy the term pregestational diabetes PGD is used In the last years much has been invested to uniformly define worldwide the diagnostic criteria and the management of gestational diabetes Recently the American Diabetes Association stated that a general screening in a low risk population should be implemented into routine prenatal care However there are still controversies on which diagnostic criteria to use Similarly screening of pregnant women at high risk for PGD is also a matter of debate This is an important issue as the prevalence of this group is increasing worldwide Of interest the ADA as well as the international expert committee on diabetes published a consensus statement in which the use of HbA1c was supported for the diagnosis of diabetes rather than the measurement of fasting or post-prandial plasma glucose in a non-pregnant population A value of 65 48mmolmol was proposed as criterion for diagnosis There is no doubt that the measurement of glycosylated haemoglobin may be of value in particular preconceptional in diabetes type 1 Difference exist in using HbA1c during pregnancy At the pregnant state the different red cell turnover and other physiologic changes in pregnancy may interfere with HbA1c Indeed mean HBA1c levels in healthy pregnant women are lower than in the non-pregnant women Moreover OConnor et al showed that first and second trimester HbA1c values are significantly different to a non-pregnant population whereas no difference was found comparing HbA1c values from the third trimester Therefore it has been suggested that only blood glucose criteria should be used to diagnose or exclude PGD in particular during the first trimester as the data on HBA1c in the first trimester is limited

Objective

To observe the values of HbA1c obtained from pregnant women in the early pregnancy the difference between those who develop GDM and those who do not and the comparison of first trimester HBA1c Plasma Glucose and angiogenesis factors

Methods

This is an observational prospective cohort study conducted in our Department of Obstetrics All women are tested for HbA1c at the first antenatal visit during the first trimester First trimester was defined as up to 12 67 weeks of gestation Between 24 and 28 weeks of gestation the women are screened as internationally proposed by a one-step standardized 75g oral glucose tolerance test oGTT Venous blood samples were collected at 0 1 and 2h after the glucose load Women with pre-existing diabetes mellitus or a first trimester HbA1c 65 are excluded from the study und medical care for pregestational diabetes is provided

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None