First Trimester Glycosylated Haemoglobin Und Plasma Glucose in Women at High Risk for Gestational Diabetes

NCT02139254 | Completed

• 1 other identifier: 030/13
• Study Type: observational
• Target: 1,800
• Locations: 1 country
• Sites: 1

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).

Conditions

Gestational Diabetes

Keywords

Gestational Diabetes; HbA1c; Glucose; First Trimenon

Outcome Measures

Primary Outcomes (1)

• Number of women with gestational diabetes

  Week 28 of pregnancy

Secondary Outcomes (1)

• Delivery Mode

  At delivery, expected to be on average after 40 weeks

Study Arms (2)

Low risk

Pregnant women with a low risk for metabolic diseases

High risk

Pregnant women with a high risk for metabolic diseases

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women who receive antenatal care at the Department of Obstetrics in our Hospital and have the first vist between 8. and 12. week of pregnancy. Women with pregestational diabetes are excluded.

You may qualify if:

• Pregnancy
• weeks of gestation
• Written informed consent

You may not qualify if:

• Pregestational diabetes

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Dep. of Obstetrics and Gynecology

Bern, 3010, Switzerland

Location

Related Publications (1)

• Amylidi-Mohr S, Lang C, Mosimann B, Fiedler GM, Stettler C, Surbek D, Raio L. First-trimester glycosylated hemoglobin (HbA1c) and maternal characteristics in the prediction of gestational diabetes: An observational cohort study. Acta Obstet Gynecol Scand. 2023 Mar;102(3):294-300. doi: 10.1111/aogs.14495. Epub 2022 Dec 16.

  PMID: 36524557 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

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

• Luigi Raio, PD

  Frauenklinik Inselspital Bern

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 13, 2014
• First Posted: May 15, 2014
• Study Start: August 1, 2013
• Primary Completion: September 29, 2017
• Study Completion: September 20, 2018
• Last Updated: October 3, 2018

Record last verified: 2018-10

Locations

CH (1)