GDM Post Partum Screening

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03946631
• Other study ID #: GDM 2019 iris 01-18-0028
• Status: Terminated
• Start date: August 20, 2019
• Est. completion date: October 21, 2022

Study information

• Verified date: December 2022
• Source: Pediatrix
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: October 21, 2022
• Est. primary completion date: October 21, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Pregnant, or recently postpartum, women with the diagnosis of GDM requiring medication therapy after 20 weeks,

• >18 years-old (yo)yo,

• English speaking.

Exclusion Criteria:

• have pre-existing type 2 DM,

• did not require anti-hyperglycemic medication therapy (GDMA1),

• early onset GDM (<20 weeks).

• do not speak English .

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes, Gestational
• Gestational Diabetes

Intervention

Diagnostic Test:
• 2 hour glucose tolerance test using 75g glucose drink
intervention 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.

Locations

Country	Name	City	State
United States	Banner - University Medical Center Phoenix	Phoenix	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Pediatrix	Banner University Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (8)

5. Biljok VR, Bozicevic S, Lovrencic MV, Car N. Performance of the StatStrip Glucose Meter in Inpatient Management of Diabetes Mellitus. Diabetologia Croatica 2010; 39-3:105-109.

Dinglas C, Muscat J, Heo H, Islam S, Vintzileos A. Immediate Postpartum Glucose Tolerance Testing in Women with Gestational Diabetes: A Pilot Study. Am J Perinatol. 2017 Oct;34(12):1264-1270. doi: 10.1055/s-0037-1606620. Epub 2017 Sep 14. No abstract available. — View Citation

Gobl CS, Bozkurt L, Prikoszovich T, Winzer C, Pacini G, Kautzky-Willer A. Early possible risk factors for overt diabetes after gestational diabetes mellitus. Obstet Gynecol. 2011 Jul;118(1):71-78. doi: 10.1097/AOG.0b013e318220e18f. — View Citation

Kjos SL, Peters RK, Xiang A, Henry OA, Montoro M, Buchanan TA. Predicting future diabetes in Latino women with gestational diabetes. Utility of early postpartum glucose tolerance testing. Diabetes. 1995 May;44(5):586-91. doi: 10.2337/diab.44.5.586. — View Citation

Mendez-Figueroa H, Daley J, Breault P, Lopes VV, Paine V, Goldman D, Francis MJ, Delgado B, Coustan DR. Impact of an intensive follow-up program on the postpartum glucose tolerance testing rate. Arch Gynecol Obstet. 2014 Jun;289(6):1177-83. doi: 10.1007/s00404-014-3157-0. Epub 2014 Jan 31. — View Citation

Su X, Zhang Z, Qu X, Tian Y, Zhang G. Hemoglobin A1c for diagnosis of postpartum abnormal glucose tolerance among women with gestational diabetes mellitus: diagnostic meta-analysis. PLoS One. 2014 Jul 11;9(7):e102144. doi: 10.1371/journal.pone.0102144. eCollection 2014. — View Citation

Vucic Lovrencic M, Radisic Biljak V, Bozicevic S, Pape-Medvidovic E, Ljubic S. Validation of Point-of-Care Glucose Testing for Diagnosis of Type 2 Diabetes. Int J Endocrinol. 2013;2013:206309. doi: 10.1155/2013/206309. Epub 2013 Dec 8. — View Citation

Werner EF, Has P, Tarabulsi G, Lee J, Satin A. Early Postpartum Glucose Testing in Women with Gestational Diabetes Mellitus. Am J Perinatol. 2016 Aug;33(10):966-71. doi: 10.1055/s-0036-1583193. Epub 2016 Apr 27. Erratum In: Am J Perinatol. 2016 Dec;33(14 ):1433-1434. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity of early postpartum overt diabetes screening by 2-hour glucose tolerance testing in postpartum women.	We will compare the sensitivity of a 2-hour oral glucose tolerance test (2HR OGTT) for the detection of overt diabetes when performed within 48 hours of delivery ("early") among postpartum women previously diagnosed with gestational diabetes requiring treatment. The "early" 2HR OGTT result will be compared to the current standard of care of a 2HR OGTT performed at 6-12 weeks postpartum.	24-48 hours postpartum verses 6-12 weeks postpartum.