Clinical Trials Directory

Trials / Terminated

TerminatedNCT03946631

GDM Post Partum Screening

Immediate Postpartum Screening for Diabetes Mellitus in Women With Gestational Diabetes.

Status
Terminated
Phase
Study type
Observational
Enrollment
21 (actual)
Sponsor
Pediatrix · Academic / Other
Sex
Female
Age
18 Years – 60 Years
Healthy volunteers
Not accepted

Summary

Immediate postpartum screening for diabetes mellitus in women with gestational diabetes The objective of this study is to determine if screening for type 2 diabetes can be done 24 hours after delivery, versus 6-12 weeks postpartum, in recently delivered women having been diagnosed with gestational diabetes requiring medication therapy in the antecedent pregnancy.

Detailed description

1 Overview The purpose of the project is to determine if screening for diabetes mellitus, in women with gestational diabetes, can be done 24 hours postpartum versus 6-12 weeks postpartum. Primary Objective: To compare the results from screening for type 2 diabetes 24 hours postpartum versus 6-12 weeks postpartum. Design and Project Type Prospective cohort study. Women diagnosed with gestational diabetes and receiving anti-hyperglycemic medication therapy will have testing for type 2 DM done 24 hours after delivery. They will also have routine screening for type 2 DM done at 6-12 weeks postpartum. Description of Intervention The intervention is early screening for type 2 DM which involves oral intake of a 75-- gram (g) glucose drink and subsequent measurement of fasting, 1- hour, and 2- hour postprandial point of care fingerstick s for blood glucose measurement. Instruments Fingerstick testing will be done with StatStrip Glucose Hospital Meter (Nova Biomedical). This device is used routinely throughout the hospital and has been validated for use in all patients, including the critically ill. Using point of care testing will allow for accurate results with less pain for the patient, as compared to (fingerstick versus venipuncture).

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TEST2 hour glucose tolerance test using 75g glucose drinkintervention is a 2 hour glucose tolerance test. Involves oral intake of a 75g glucose drink followed by using point of care testing. Glucose drink is taken after at least 6 hours of fasting. Fingerstick blood glucose testing done at three time points: fasting, one hour post drink and two hours post drink.

Timeline

Start date
2019-08-20
Primary completion
2022-10-21
Completion
2022-10-21
First posted
2019-05-10
Last updated
2022-12-14

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03946631. Inclusion in this directory is not an endorsement.