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OpenTrials
Completed

NCT Number: NCT04108455

Biomarkers During Pregnancy

This study aims to obtain preliminary data for utility of alternate biomarkers for monitoring glucose control in diabetic women during pregnancy and/or predicting risk of adverse neonatal events in these women.

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Key information

About this study

This study aims to obtain preliminary data for utility of alternate biomarkers for monitoring glucose control in diabetic women during pregnancy and/or predicting risk of adverse neonatal events in these women. Our population is unique compared to published studies and contains significant numbers of African American women and overweight or obese women. Two of these markers have been examined in several other populations of pregnant women and have shown utility for both outcomes. However, the recommended levels of these markers need to be determined in specific populations as ethnicity and BMI affect the values. Values obtained in recruited women will be compared with biobank samples from women who have no evidence or history of diabetes. Additionally, two other potentially promising markers will be examined (beta-hydroxybutyrate and triglycerides). Both these analytes change during pregnancy and beta-hydroxybutyrate has shown correlation with large for gestational status or macrosomia in some studies. A combination of markers may be a better predictor of adverse neonatal outcomes than a single marker.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All women included in the study will either have diabetes diagnosed before pregnancy or will have been diagnosed during pregnancy (GDM). We do not exclude minors, since in Missouri, they may consent to medical treatment without parental consent for medical issues relating to pregnancy,

Exclusion criteria

  • No specific exclusion criteria will be used. BMI data will be collected and utilized to sort patients into various subgroups, but will not be used as exclusion criteria.

Treatment and study plan

Specimens Collected

Other

Serum will be collected from patients at multiple times during pregnancy for later analysis.

Primary outcomes

  1. Glucose Control

    Time frame: up to 60 weeks from enrollment

    various measures of glucose control will be reported and compared to other biomarkers measured by the study

  2. Adverse Neonatal Events

    Time frame: up to 60 weeks from enrollment

    various adverse neonatal events will be reported and compared to other biomarkers measured by the study

Secondary outcomes

  1. Glycated Albumin

    Time frame: up to 60 weeks from enrollment

    Levels of % glycated albumin will be measured in the various cohorts to see if correlations exist with glucose control and adverse neonatal events

  2. Glycated Serum Protein (GSP)

    Time frame: up to 60 weeks from enrollment

    Levels of glycated serum protein will be measured in the various cohorts to see if correlations exist with glucose control and adverse neonatal events

  3. Beta-hydroxybutyrate

    Time frame: up to 60 weeks from enrollment

    Levels of beta-hydroxybutyrate will be measured in the various cohorts to see if correlations exist with glucose control and adverse neonatal events

  4. Triglycerides

    Time frame: up to 60 weeks from enrollment

    Levels of triglycerides will be measured in the various cohorts to see if correlations exist with glucose control and adverse neonatal events

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

Alternate Biomarkers for Better Management of Diabetes During Pregnancy and Prediction of Neonatal Complications in Pregnant Women With Diabetes

Important dates

Study start
2019
Primary completion
2021
Study completion
2024
First posted
Sep 30, 2019
Registry last updated
Aug 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.