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NCT05067075 · ClinicalTrials.gov registry record · NA
The CGMS in GDM Labor and Delivery Study
A NA study of Gestational Diabetes Mellitus in Pregnancy, sponsored by Woman's.
- Completed
- Registry status
- NA
- Development phase
- 61
- Enrollment target
- 1
- Study location
NCT05067075 is a NA study of Gestational Diabetes Mellitus in Pregnancy that has completed, run by Woman's. The registered enrollment target is 61 participants, below the 1,869-participant average among 9 other Gestational Diabetes Mellitus in Pregnancy trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05067075, a NA study of Gestational Diabetes Mellitus in Pregnancy, has completed, sponsored by Woman's.
- COMPLETED
- Registry status
- NA
- Development phase
- 61 participants
- Enrollment target
- 1
- Study location
Study Summary
Glucose control during labor is important for both fetus and mother. During labor and delivery, the goal is to maintain the sugars in the normal range as safely as possible as increased blood sugars 4-6 h prior to delivery leads to increased rates of hypoglycemia in the neonate. Neonatal hypoglycemia is a risk for the offspring of pregnant women with diabetes and occurs when fetal pancreatic hyperplasia is acutely stimulated by a high fetal glucose level derived from maternal hyperglycemia during labor. The maternal blood glucose level during delivery is a predictor of the neonatal blood glucose level. Modern continuous glucose monitoring (CGM) systems can capture the direction and magnitude of short-lived changes in interstitial glucose levels and are therefore useful for assessing glucose variability more accurately than self-monitoring blood glucose (SMBG) measurements. Indeed, it has already been demonstrated that intermittent blood glucose monitoring underestimates the number of hyperglycemic events, because blood glucose excursions can peak at different times of day. CGMs can help identify glycemic patterns in pregnancy, obtain and maintain glucose targets, and reduce hypoglycemia. Strict glycemic control during labor and delivery may reduce the risk of neonatal hypoglycemia. Two groups have reported on the use of CGM in type 1 diabetics during labor in small pilot studies. Another study looked at effects of maternal glucose levels in insulin-treated women during labor and delivery (2 to 8 h before birth) and resultant neonatal hypoglycemia. The researchers found that maternal hyperglycemia before delivery was correlated with neonatal hypoglycemia. Although more studies are needed, CGM use has promise as a therapy to improve outcomes in pregnancies associated with diabetes. In this study, the investigators plan to explore whether the use of blinded glucose monitoring during labor, delivery, and early postpartum supplementary to normally monitored plasma glucos
Conditions Studied
Interventions
- DEVICE Blinded CGM
Study Locations (1)
Louisiana
- Woman's Hospital - Baton Rouge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2021-11-01 |
| Est. Completion | 2023-04-18 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05067075
The ClinicalTrials.gov registry entry for NCT05067075 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 61 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,869-participant average among 9 other Gestational Diabetes Mellitus in Pregnancy trials with a reported enrollment target (97% lower). The listed sponsor is Woman's, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Gestational Diabetes Mellitus in Pregnancy appearing as the primary indexed condition, and to 1 intervention - of which Blinded CGM is the first listed.
NCT05067075 reports 1 study location spanning 1 distinct geographic area - top geographies include Louisiana.
Frequently Asked Questions
What is clinical trial NCT05067075 about?
NCT05067075 is a clinical study titled "The CGMS in GDM Labor and Delivery Study". Glucose control during labor is important for both fetus and mother. During labor and delivery, the goal is to maintain the sugars in the normal range as safely as possible as increased blood sugars 4-6 h prior to delivery leads to increased rates of hypoglycemia in the neonate. Neonatal hypoglycemi...
What is the current status of trial NCT05067075?
This trial is currently completed. It is a NA study. The enrollment target is 61 participants. The study started on 2021-11-01. Estimated completion is 2023-04-18.
What conditions does trial NCT05067075 study?
This clinical trial studies the following conditions: Gestational Diabetes Mellitus in Pregnancy.
What interventions are being tested in trial NCT05067075?
The interventions under investigation include: Blinded CGM (DEVICE).
Who is sponsoring clinical trial NCT05067075?
This trial is sponsored by Woman's, which has 17 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05067075 being conducted?
This trial has 1 study location across Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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