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Clinical trialNCT05067075CompletedInterventional

The CGMS in GDM Labor and Delivery Study

SponsorWoman'sEnrollment61Gestational Diabetes Mellitus in Pregnancy
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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 glucose measurements in women with gestational diabetes (GDM) would provide useful information to improve glycemia during labor in this diabetic population. All CGM data will be masked and therefore not available to participants, clinicians, or researchers at the time of delivery. Participants otherwise will receive standard clinical care. The blinded glucose monitoring data on glycemia throughout labor and post-delivery will be retrospectively assessed.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

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Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Woman'S Hospital

    Baton Rouge, Louisiana, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
1 Nov 2021
Primary completion
18 Apr 2023
Completion
18 Apr 2023
Last update posted
28 Aug 2023
Registered enrollment
61
Registry id
NCT05067075

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.