Trials / Unknown
UnknownNCT04108455
Biomarkers During Pregnancy
Alternate Biomarkers for Better Management of Diabetes During Pregnancy and Prediction of Neonatal Complications in Pregnant Women With Diabetes
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 47 (actual)
- Sponsor
- Washington University School of Medicine · Academic / Other
- Sex
- Female
- Age
- 14 Years – 48 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Specimens Collected | Serum will be collected from patients at multiple times during pregnancy for later analysis. |
Timeline
- Start date
- 2019-03-15
- Primary completion
- 2021-11-01
- Completion
- 2023-11-30
- First posted
- 2019-09-30
- Last updated
- 2023-05-06
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04108455. Inclusion in this directory is not an endorsement.